5 - Training Manual PDF

Comparison of Age-Related Macular Degeneration Treatment Trials (CATT)
Oracle Clinical Remote Data Capture Users Manual
Version 1.01_20080904
Prepared by: Clinical Research Computing Unit (CRCU) Center for Clinical Epidemiology and Biostatics (CCEB) University of Pennsylvania School of Medicine 3535 Market Street, Suite 560 Philadelphia, PA 19104-3309
THESE DOCUMENTS ARE THE PROPERTY OF THE CLINICAL RESEARCH COMPUTING UNIT (CRCU), A DIVISION OF THE UNIVERSITY OF PENNSYLVANIAS SCHOOL OF MEDICINE AND THE CENTER FOR CLINICAL EPIDEMIOLOGY AND BIOSTATISTICS (CCEB). THESE DOCUMENTS CONTAIN PRIVILEGED, PROPRIETARY, OR OTHERWISE PRIVATE STUDY INFORMATION AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED WITHOUT THE EXPRESS WRITTEN CONSCENT OF THE CLINICAL DATA MANAGEMENT DIVISION OF THE CLINICAL RESEARCH COMPUTING UNIT (CRCU).
Table of Contents
I Installation and Getting Started 1.1 1.2 1.3 1.4 RDC Software Installation Connecting to the Oracle Clinical RDC Application Medication Reference Tool Downloads Troubleshooting RDC Installations page 1 page 2 page 7 page 9 page 11
II
Logging-In
page 15
III
Navigation and General Overview 3.1 3.2 3.3 3.4 News Items Activity List Command Buttons and Menus Main Spreadsheet
page 18 page 18 page 19 page 27 page 38
IV
Printing Case Report Forms (CRFs) 4.1 4.2 Printing CRFs from CATT Landing Page Printing CRFs from an Open PDF
page 47 page 48 page 55
Accessing Study Tools Adverse Event Coding and Concomitant Medication Coding 5.1 5.2 5.3 5.4 Adverse Event Coding Additional Adverse Event Pages Concomitant Medication Coding Additional Concomitant Medication Pages
page 56 page 57 page 67 page 70 page 78
VI
General Data Entry Instructions 6.1 6.2 Patient Registration Entering CRFs
VII
Discrepancy Management 7.1 7.2 7.3 Accessing Discrepancies Correcting Errors Creating Manual Discrepancies
page 96 page 97 page 102 page 109
VIII
Randomization, Patient Visit Calendar, and Patient Randomization Assignments 8.1 8.2 Patient Randomization Patient Visit Calendar and Randomization Assignment
VIII
List of Abbreviations
page 125
VIV
Glossary
page 126
Oracle Clinical Remote Data Capture Installation and Getting Started

Personal Computer (PC) Requirements For Oracle Clinical Remote Data Capture (RDC) users: Windows 2K (any release, although preferably Service Pack [SP] 4), XP Home or Professional (SP2) 1 . An account that can install software (i.e., must be able to modify registry entries), preferably with administrative privileges. Adobe Acrobat Reader (or Professional) 6, 7, or 8 installed (any subrelease). o If Adobe is not installed, it can be downloaded from the Adobe website http://www.adobe.com. Follow the installation instructions provided by Adobe.
Internet Explorer (IE) 6 or above. If the users internet browsers popup blocker is enabled, make sure to allow popups from the following websites: rt1.cceb.med.upenn.edu and rt4.cceb.med.upenn.edu. If your browser has Yahoo Search, Google Toolbar, AOL Toolbar, Windows Messenger add-ons, they should be disabled 2 . o To disable them in IE 6, the add-on needs to be removed using the Control Panels Add or Remove Programs tool. To disable then for IE 7, go to the Tools menu and select Manage Add-ons; click on the add-on and check Disable. Repeat for each add-on found. You need to restart IE for the changes to take effect.
Citrix: If Citrix is used at the users site, IT personnel should assist in the installation of RDC software. The IT personnel will need to make sure that either: o The users account has write access to its remote Document and Settings folder and Citrix servers registry, or The users account is setup so that RDC installation can be done locally on the users Personal Computer (PC), on which the account has administrative privileges.
1 2
Vista and Apple Macintosh OS are not supported at this time. There is a conflict between this tools Java Virtual Machine and one of the two installed for RDC. Oracle Clinical Users Manual Page 1 of 137
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1. RDC Software Installation To install the software necessary to access Oracle Clinical Remote Data Capture (RDC) database, open your IE browser and go to the CATT Study Main Landing Page: http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html
To access RDC, click on the hyperlinks outlined above, (the direct link is http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm). This will bring the user to the RDC Main Landing Page.
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Click on the Downloads (http://rt1.cceb.med.upenn.edu/opa45/opa45_download.htm) link, outlined above. The following page will come up:
Installing Jinitiator Under the heading Jinitiator, click on the Download link (http://rt1.cceb.med.upenn.edu/jinitiator/jinit.exe). The user will be prompted to save or run the self-extracting jinit.exe file, which is necessary to access Oracle Clinical. Save this file to the users PC and double-click on it (or simply click on the Run button of Internet Explorers download window). Jinitiator installation will begin.
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Click OK and, after unpacking the jinitiator software, the welcome screen will display:
Click Next and the installer will prompt you for a location:
The installers default location C:\Program Files\Oracle\Jinitiator 1.1.8.24. Click Browse if the user would like to change this location. Otherwise click Next and the installer will perform the installation. Installing OPA PDF Plugin
Before you download the OPA PDF plugin, make sure that Adobe Acrobat 6.0, 7.0, or 8.0 Reader (or equivalent Professional) is installed on the users PC.
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In Start/Programs/Jinitiator Control Panel 1.1.8.24/ Basic tab check that Network Access is set to Unrestricted (default is AppletHost). On the OPA Download page shown on page 3, under the Jinitiator section, the user will see the heading RDC Plugin. Within this area, click the link Download - OPA RDC plug-in (US-English). An alert will prompt you to download the opapdf.exe file. Click Save to save this to the users PC, noting the location where it is saved. After the download is complete, double-click the link to execute the installation, or find opapdf.exe and double-click on it.
This Installation Wizard will start and asks the user to accept the legal terms of using copyrighted software.
After click Yes, the download will proceed.
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Click Finish to exit. At this point, the user has installed the software needed to run Oracle Clinical Remote Data Capture (RDC). The user will also need to install a plug-in to access the Medication Reference Tool, follow the instructions on page 9 of this guide.
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2. Connecting to the Oracle Clinical RDC application As previously discussed, the user may start from CATT Main Landing Page: http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html or directly go to RDC Main page (http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm). From the RDC Main page, click the Login button. The following window will display on the users screen:
Do not close this window, as it is required during the users session while connected to the database. This window may be minimized, but must remain open while using RDC. The first time a user logs into Oracle Clinical RDC, the components will automatically download and update the RDC environment.
Once these downloads are complete, the objects will be cached in the users system, which will allow the user to log in faster in the future. Finally, the user will be presented with the login screen to Oracle Clinical RDC.
Enter the username, password and database. If the log is successful, the Activity List will be displayed.
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Click File/Exit at any time to exit.
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3. Medication Reference Tool Downloads An additional Java plug-in is needed for accessing the Medication Reference Tool, together with security certificates. They can both be downloaded from the following webpage: http://rt4.cceb.med.upenn.edu/crcu_html/jinit/jinit_download.htm.
Install Oracle JInitiator 1.3.1.22 by double clicking on the link, this will initiate the selfextracting file. Save the file to the users desktop and install accepting all defaults:
Next, install Certificate Installer by double clicking on the link. This will download the selfextracting file. Save the file to the users desktop.
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Click on Run to start the installation. If the user does not need to install in a location different from the default (C:\Program Files\Oracle\Jinitiator 1.3.122) then the user can accept all defaults and the software will be ready to use.
Once the Jinitiator 1.3.122 and the certificates are installed, the Medication Reference Tool can be accessed at any time - instructions for accessing the Medication Reference Tool are discussed on pages 70 80.
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4. Troubleshooting RDC Installations This section contains some of the most common issues users have encountered while downloading or deploying RDC, and this section will provide some possible solutions or workarounds. The issues listed in this section are by no means exhaustive, given the large variability in Operating Systems (OS) levels, browser types and versions, and Adobe Acrobat Reader configurations. The FAQ section of the CATT Main Landing Page (see below) will be updated as new issues come up.
In case none of solutions listed here or in the FAQ section solves the users problem, please do not hesitate to contact CRCUs Help Desk via email (crcuhelp@mail.med.upenn.edu) or phone (1.215.573.4623).
I.
Error extracting Jinitiator Reason: Account has no administrative privileges Fix: Install as Administrator
II.
Jinitiator installer hangs Reason: A mapped drive is unavailable Fix: Go in Windows Explorer and look for any drive (physical or virtual) that cannot be opened. Disconnect it and retry Reason: Issue with 16-bit subsystem
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Workaround: Try changing the tmp and temp environment variables in user profile to c:\temp. They might be set to %USERPROFILE%\Local Settings\Temp by default. The older 16-bit InstallShield can't handle long names. Retry.
III.
Jinitiator installation does not complete. Reason: In a few cases, if you do not have administrative privileges on the machine you are installing Jinitiator onto, the Jinitiator installer will fail to update the Windows registry. Workaround: Find your username in the Users and Passwords of your PC. Select it and check its Properties. The user should be in the Administrators or at least in the Power Users group. If it is not, your technical support should login as Administrator or give your user account the right privileges. After that, try running the installation again and it this time it should complete.
IV.
Jinitiator installs, but nothing else happens. Reason: Your security rules may not allow the browser to spawn the Jinitiator applet. Workaround: For Internet Explorer, check the Internet Options. Make sure that security level is not set to High for the zone our web server is in. Also, check in Advanced that you can run ActiveX controls and set the ActiveX options to at least Prompt level. Should the above steps fail to solve your issue, make sure popup blocking is on for our site: in IE 6.0, go to Tools/Popup blocker and make sure our site is allowed popups. In IE 7.0, bottom left corner of the screen, click the document icon, and
V.
Get error Your security settings do not allow Web sites to use ActiveX controls installed on your computer. This page may not display correctly These steps may resolve the issue: 1. 2. 3. 4. 5. 6. Open Internet Explorer. Select Tools then Internet Options from the menu bar. Click on the Security tab. Select a network zone 3 Press the Custom Level button near the bottom of the screen. In the Security Settings screen that opens, under Reset custom settings at the bottom on the screen, select Medium from the drop-down menu, and click the Reset button. 7. In the Settings list at the top of this screen, scroll down under the ActiveX controls and plug-ins option (this is the first option) until you see the option Run ActiveX controls and plug-ins. Make sure that the radio button next to Enable is selected for this option. 8. Click OK to apply. 9. Back in the Internet Options screen, click the OK button. Close, relaunch the browser, and try again to connect to our URL.
We suggest you change security levels for a network zone you can trust, like Trusted sites or Local Intranet. Never change the defaults for the Internet zone, since those changes may decrease your Internet browsing security. You should therefore place our website in your Trusted sites or Intranet zones and customize the security settings there. V1.01_20080904 Oracle Clinical Users Manual Page 12 of 137
VI.
Blank Internet Explorer window when attempting to open the application URL This is usually is a sign that the Jinitiator installer is unable to install the plug-in due to the Internet Options settings on your computer. Here are a set of steps that may solve your problem: 1. In Internet Explorer, go to Tools - Internet Options and select the Security tab. Highlight the Web zone that matches the icon appearing at the bottom right of the Browser window. Click on the Custom Level button. 2. Make sure that the following options are set to the Prompt or Enable level: a. Download signed ActiveX controls - Prompt b. Run ActiveX controls and plug-ins - Enable (or Prompt) c. Script ActiveX controls marked as safe for scripting - Enable (or Prompt) 3. Go to Tools - Internet Options and select the 'Advanced' tab. 4. Make sure that Do not save encrypted pages to disk is NOT checked. 5. If none of the above solves your problem, please contact the CATT Help Desk.
VII.
PDF does not open up Reason: IE link to Acrobat broken Fix: Reinstall Acrobat Reader and RDC plugin Reason: Pop-up blocker has not been disabled Fix: Enable pop-ups from rt1.cceb.med.upenn.edu, rt4.cceb.med.upenn.edu in Internet Explorers Tools/Pop-up Blocker/Pop-up Blocker Settings Note: Some toolbars, like Google Toolbar, have built-in pop-up blocker functions. Also, some computer systems may have specialized tools like Popup Inspector to monitor and block pop-ups. Make sure pop-ups from our sites are enabled in these tools. If the problem persists, try disabling / uninstalling these tools.
VIII.
DCI does not come up in Acrobat window Reason: IE link to Acrobat broken Fix: Reinstall Acrobat Reader, and RDC plugin
Reason: Popup blocker enabled Fix: Enable pop-ups from rt1.cceb.med.upenn.edu in IE

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Note: Some add-ons, like Google Toolbar, have pop-up blocker functions. Also, user could have installed specialized tools like Popup Inspector. Make sure pop-ups from our sites are enabled in these tools. If problems still persist. The user may want to disable / uninstall these add-ons
IX.
Get "Cannot contact host 127.0.0.1 port 5567" when opening a DCI form Reason: Improper setting in Jinitiator 1.1.8.24 Fix: Go in Start/Programs/Jinitiator 1.1.8.24 Control Panel and change Network Access to 'Unrestricted'. Hit 'Apply' button and exit Reason: A local firewall may be blocking port 5567 Fix: Windows firewall or a tool like Symantec Internet Security Suite may be blocking Acrobat from using the PDF plugin. Try to enable local traffic on that port you may need your IT person help) and retry.
X.
IE crashes while launching RDC Reason: JIT compiler enabled in IE Fix: Go in Internet Options/Security. Select Internet zone for RT1. Select 'Custom Level' and uncheck 'Enable JIT compiler' (Usually this issue happens in IE 6.0 with MS JVM installed)
XI.
IE crashes (GPF) while launching Medication Reference tool Reason: Third party IE add-ons Fix: Go to 'Manage Add-ons' and disable any 'Windows Live..', 'Google...', 'Yahoo ...', or AOL add-on Note: Oracle has a possible workaround for this issue, but we are still testing it at this time. It requires substituting jvm.dll in Jinitiator' Hotspot folder with JDK 6's one.
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Oracle Clinical Remote Data Capture Logging-In

1. The CATT Study has been provided with a study specific landing page, which will house links for Logging into the Data Management System (DMS); reference tools for Adverse Event and Concomitant Medication coding; links for study specific Reports; and links for accessing CATT Case Report Forms (CRFs). The URL for the CATT Landing Page is http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html Instructions for accessing the various components of the CATT Landing Page will be described in detail throughout the course of this manual. To Login to the CATT DMS via Oracle Clinical Remote Data Capture (RDC) from the CATT Landing Page, click on either of the hyperlinks: RDC Login or Oracle Clinical Remote Data Capture RDC Login outlined below:
By clicking on either of these links, the user will be taken to the Main Landing Page of RDC.
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2.
Users can either access the Main Landing Page of RDC via the CATT Landing Page as described above, or by entering the following URL http://rt1.cceb.med.upenn.edu/opa45/rdclaunch.htm - for RDC into an Internet Explorer web-browser and click on the Login button to launch the application.
Note: Users will be given access to the CATT training database initially, and after they have been certified, the user will be given access to the live study database. A News Item (described in the next section, page 18) will inform the user as to which database they are accessing.
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3.
In the Log-in box enter the Username, Password, and Database name provided by the CRCU Database Administrator:
Username: ________________________________________ Password: ________________________________________ Database: ________________________________________ After entering all of the information in the LOGON fields, click on CONNECT
** Note: This Username and Password will be used for all applications that will be accessed by the User **
It is important that you keep your login information confidential. This information acts as an electronic signature, and attaches your name to any changes, updates, additions, or modifications within the Oracle Clinical system and can be tracked through the Audit Trail.
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Oracle Clinical Remote Data Capture Navigation and General Overview

1.
News Items:
After logging into Oracle Clinical Remote Data Capture (RDC), the first screen encountered by the user is the News Item screen. News items group, site, or individual messages can be created by users who have access to the administration module of Oracle Clinical. These news items will be the first screen displayed after a user has logged into the system and can help disseminate valuable study information to users. News items are displayed anytime a user logs-in to the system, and are usually displayed for a predetermined amount of time.
In the example above, the message reads: Welcome to the CATT Training Environment. Please note this database is for testing / training purposes only. Do not enter study data for any enrolled participants. This message signifies that the user has entered into the training environment. To move onto the next screen, click OK.
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2. The next screen is the Activity List screen, displayed below.
This screen will display any activities (data entry, discrepancy management, etc) for a particular site and user based on the users unique login privileges and assigned role.
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2a.
The Navigation Pane of the activity list with the site node expanded is outlined below.
The navigation pane with clickable nodes presents a hierarchical listing of the current study, site listings, and assigned patient positions. To expand a node click on the + sign. To contract a node click on the - sign. The branching diagram above shows the individual nodes associated with the CATT study: Study: Site: Patients: CATT CATT 30-1 30100 30114
In the example above, none of the patients have been registered.
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In the example above, patients 30189, 30194, 30195, 30196, 30197, 30198, and 30199 have data entered into the system, this is signified by the icon of a person to the left of the patient number. 30195 30199s icons are red because these patients currently have outstanding discrepancies.
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2b.
The Task Pane of the activity list is outlined below.
The Task Pane presents a listing of activities, or tasks associated with the currently selected node in the navigation pane. By clicking on a task, Remote Data Capture (RDC) retrieves the data necessary to complete the task from the study database. In the example above, RDC will allow users to review discrepancies or Show All Data for CATT. These tasks can be limited to site CATT30-1 (or an individual patient within the site), by clicking on the node that says Site: CATT 30-1 in the Navigation Pane (example outlined below).
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2c.
The Search Window of the activity list is outlined below.
The search window provides access to different criteria, which can be modified from default values that the system combines to retrieve CRFs from the study database. Load Filter, will allow the user to load any saved study searches. It will limit the scope of the data displayed in the Navigation and Task panes of the Activity List, as well as populate the main menu based on the saved search parameters. It allows the user to generate a more discrete and focused workset that is still based on a specific activity. Search, will allow a user to define search criteria, which can be modified from default values that the system combines to retrieve CRFs from the study database. (See example of the search screen display on the next page). Cancel, will present the user with three options: Change Study, Exit RDC, or Return to Search. Help, will provide the user with more information on the Activity List and give them the ability to search for keywords or topics for further information.
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When a user selects the SEARCH button, a list of seven search criteria opens. Each of these criteria can be customized to help tailor a user search for data within a workset. All of the criteria, displayed below, are set to their default values for the CATT study.
Depending on a users permissions and privileges, all of the search criteria can be modified (these are described on the following page):
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Book this will allow users to specify a study for viewing data. Site this will allow users to specify individual sites or all sites. Patients this will allow users to specify a patient, a set of patient, or all patients. Visits / Pages this will allow users to specify individual visits, groups of visits, or all visits and or pages. CRF Status this will allow users to view specific CRFs with active discrepancies, no discrepancies, locked, or all CRFs. Date Window this will allow users to view data for a specific date, a range of dates, or all dates. Data this will allow users to view data for specific CRFs, sections, lab ranges, comment types, etc.
Click OK to run the defined search parameters. Click Load Search to load a previously saved search. Click Cancel to exit this screen. The Change Study button is not applicable to the CATT study. This button is used by individuals who have multiple studies within RDC and allows them the ability to switch from one study to another.
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2d.
Summary Data and Statistics are displayed in the Summary tab located below the Activity List pane, outlined below.
The left hand box provides Study Information Study title, number of sites, and overall site participant summaries. The right hand box provides Study CRF Information (for an individual site) number of CRFs (both planned and unplanned), number of CRFs that have been verified, number of CRFs with discrepancies (active, other, and clean), number of CRFs that have been approved, and the number of CRFs that have been locked.
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3.
Other command buttons and drop menus from the Activity List / Oracle Clinical Tool Bar:
The command buttons are outlined above, please see the following pages for further explanations.
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The person with a gold star (first icon) will allow a user to insert a new patient. When this button is toggled, a drop down box of predefined Patient Identification Numbers (PIDs) will be displayed; the user can select the appropriate number and begin data entry. The gold disk (second icon) will allow a user to save any data they are currently working on. The page with an arrow pointing left (third icon) and the page with an arrow pointing right (fourth icon). These buttons allow a user to move to a previous or next CRF. The face with quotation bubble (fifth icon) will allow a user to display Investigator Comments This feature is not being used for this study. The two-tone page with a star (sixth icon), will allow a user to display any active (open) or other (manually created) queries. Finally, the blue Question mark will allow a user to access the help menu.
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3a.
Based on the current view (Activity List) some of the functions in the drop down Oracle Clinical tool bar will not be accessible. These options become active when the user moves from the Activity List to the Main Menu Screen.
The drop down Oracle Clinical tool bar is outlined above, each element is described on the following pages.
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File:
Allows the user to perform a variety of search functions Create a New Search, Load a Search, Modify an existing Search, Save a Search. This menu also allows a user to: Change Studies Not applicable to the CATT study. Obtain any current or updated study related News. Print study-specified Reports and CRFs, which can be printed or saved from their pdf format. Print the current screen. Save any data the user has been working on. Refresh update the window and current data for the users existing session. Exit Exit Oracle RDC. Please use this option to exit any time you wish to quit your current Oracle Clinical Session.
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Edit:
The only options available from the Edit drop down menu in the Activity List view are: Preferences and Maintain Search. The other Edit options Cut, Copy, Paste, Duplicate Field allow a user to cut, copy, paste, or duplicate field responses when performing data entry. Delete CRF and Field Editor are not always active privileges for a user, these are high level functions that allow data managers, study officers, and designated personnel to: Delete CRF clear CRF answers (if a CRF was mistakenly entered under the wrong PID). Field Editor allows a user to edit the length, acceptable values, and other elements of a given data element.
Discrepancy, Discrepancy (manual), Section Discrepancy, and Investigator comments will allow users to access individual discrepancies, discrepancy definitions, discrepancies for a given section, and let them view Investigator comments. Preferences if active based on your user role will allows a user to modify their display preferences for example, as a user preference individuals can set their date display format to 01-JUL-2007 instead of 07-01-2007 Maintain Search allows a user to view their complete list of saved searches. From this window the user can modify, delete, or change any of their saved searches.
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Insert:
The only options available from the Insert drop down menu in the Activity List view are: Patient, CRF, and Visit. Patient this option will allow a user to enter a new patient. After selecting patient, a drop down window with a list of PIDs will appear and allow the user to select a patient number. CRF this option will allow a user to enter a new CRF. After selecting CRF, a drop down window with a list of CRF abbreviation names will appear and allow the user to select a CRF for a specific patient. Visit this option will add an unplanned visit after the current visits. Use this option only if the user has unplanned visit data. This will be used as the preferred means to insert additional Treatment Evaluation (TE) forms.
The options not available from the Insert drop down are: Discrepancy (manual) allows a user to create a discrepancy on a specific question. Section Discrepancy allows a user to create a series of discrepancies on a given section of a CRF. Investigator Comment provides a pop-up comment field to be attached to any question. This comment field can be used to write in any additional notations, comments, or questions. Users must have the appropriate privilege in order to insert an Investigator Comment.
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CRF:
None of the options from the CRF drop down menu are active in the Activity List View. To activate these menu options the user must be in the Main Spreadsheet or the Data Entry screen.
Previous Move from the current CRF to the previous CRF within a visit window. Next Move from the current CRF to the next CRF within a visit window. Insert Row This option is only active for those CRFs that have repeating rows of values. This will insert an additional row for data entry. Delete Row This option is only active for those CRFs that have repeating rows of values. This will delete rows. Lock If a user has the appropriate permissions, they will be able to Lock a CRF. This is not used for the CATT Study. Unlock If a user has the appropriate permissions, they will be able to Unlock a previously locked CRF. This is not used for the CATT Study.
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Group Activities:
None of the options from the Group Activities drop down menu are active in the Activity List View. To activate these menu options the user must be in the Main Menu and have the appropriate permissions and privileges. These features will not be used for the CATT Study. These options allow for validation, approval, and locking of CRFs (individually, specific patient, entire site, or entire study). This role is only assigned to a few core study personnel, and will not be described in detail. The users needing to access this drop down box will be given specific instructions and training.
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Validate:
The Validate drop down menu will allow a user to run validation on a specific Patient, Site, or Study. o Patient this option will run validation on all of the CRFs that have been entered for an individual patient. Site this option will run validation on all of the CRFs entered for a given site. Study this option will run validation on all of the CRFs entered for the entire CATT study.
o o
After validation has been run, those data elements that need correction will appear as Red CRF pages in the Main Spreadsheet view.
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Help:
The Help drop down menu will give users the ability to search for help topics, give useful hints, and allow users to query an external Oracle Clinical web-page for additional help topics and search options.
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Window:
The Window drop down menu will let a user change from one open Oracle Clinical window to another, allow a user to change the way tiles are oriented, or allow a user to cascade the windows. The views will stack open windows based upon the options selected.
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4. After selecting the hyper link: Show All Data for CATT from the task pane of the activity list window, the main Oracle Clinical spreadsheet screen should be displayed. This screen will be referred to as the Main Spreadsheet.
The current view (All patients, all pages) is displayed in the white bar under the spreadsheet outlined above. These views are dependent upon a users role and for this example; the user only has access to Site 30-1 and will only be displayed data for that site. If any of the criteria had been changed from the Search Window or Activity List, it would be displayed here (See below for two examples of different search criteria).
To return to the Activity List, press the toggle that says Activity List.
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4a.
Visits for this study run horizontally across the top of the Main Spreadsheet, and are outlined below.
The top portion the tabs represents individual visit numbers. In the example above, Weeks 000 100 are displayed. The blue boxes under the tabs represent individual forms within a given visit. In the example above, the first form for Week 000 is a PR (Patient Registration) form. Some forms, like the Additional Information on Women of Childbearing Potential (CP), can be accessed by clicking on the Show Unplanned Pages box.
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To access additional Weeks, not currently displayed in the Main Spreadsheet, click on the double arrow button at the end of the Weeks tabs.
Clicking on this arrow will display all Weeks in a drop down menu for the CATT study:
From the drop down list, the user can access Weeks 104, PRN, AE, and CMED.
Note: If the user cannot see the full drop down list, they may need to adjust their computer screen resolution.
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4b. Study Participants for this study run vertically down the left hand side of the Main Spreadsheet and are outlined below.
The individual rectangles will display the Patients. In the example above, there are 8 patients displayed. As a study acquires more registered participants, a drop down menu will appear above the Participants column and allows for sorting / displaying of those participants enrolled at a particular study site.
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4c.
Summary and Statistical data are listed in the Summary Tab, outlined below.
Similar to the Summary Tab located on the Activity List, this summary tab will allow a user to view summary data based on Patient, Page, CRF, or Visit.
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Patient drop-down option, provides the statistics and summaries for a given patient make sure you have highlighted one of the patient numbers running down the vertical side of the spreadsheet above the Summary tab section:
The first statistics column displayed here, Patient Summary, is a summary of the patient demographics: Patient: Initials: Birthdate: Sex: Age: Site: 30150 BVNI This is the Alpha Code 01-DEC-1962 M 65 CATT 30-1
The second statistics column displayed here, Discrepancies, is a summary of all discrepancies based on edit checks and validation for this patient : This column will display the total number of discrepancies for the patient. It is possible for multiple fields on a given CRF to create active discrepancies; each of these multiple discrepancies would be counted and listed in this column. In the example above, there are no active (open), no other (manually generated), and no closed queries / discrepancies for this patient.
The third statistics column displayed here, CRFs, is a summary of CRFs for this patient: This column will display the total number of CRFs with active (open) and other (manually generated) discrepancies, and clean CRFs for this study. This will display the number of open discrepancies at a CRF level, meaning that if a CRF has 5 open discrepancies it is only counted as 1 in this summary.
The fourth statistics column displayed here, CRF Status, is not used for the CATT Study. This column is a summary of CRFs that have been verified (or validated), meaning that validation rules have been run against the saved data. The fifth and final statistics column displayed here, Visits, shows the current visit (000 in the case above), current entry dates, any dates data was updated, future visits and dates (based on a visit window), and lists any missing pages / CRFs.
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Page drop down option, provides the statistics and summaries for an individual page (click in one of the CRF boxes in the spreadsheet):
The first statistics column displayed here, Patient Summary, details the page number, visit, CRF name, and Site for a selected CRF. The second statistics column displayed here, CRFs, shows the number of active (open), other (manually generated), and clean discrepancies for a selected CRF. This column also shows when data entry began entering this CRF and the date the CRF was updated. The third and final statistics column displayed here, CRF Status, will display data based on the verification and approval processes for this study. This will not be used for the CATT Study.
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CRF drop down option, provides the statistics and summaries for a selected CRF (click in one of the CRF boxes in the spreadsheet):
The first statistics column displayed here, CRF Summary, provides the basic information for a selected CRF. In the example above, we can see: Patient: 30150 Visit: 000 Page Number: 1 CRF: PR Date: Blank this field is not in use for the CATT Study Document Number: This is a unique number that gets assigned by the system for each individual CRF that gets created within Oracle Clinical. Status: Entry Complete This status will change based on the Data Entry Status of the CRF.
The Data Entry Statuses are: Entry Started CRF entry begun, but saved as incomplete. Entry Complete CRF entered and saved as complete. Verified CRF entered, saved, and validation / discrepancies have been run against the entered data. This will not be used for the CATT Study. Approved CRF entered, saved, validated, and approval has been given by a study designated approver (PI, Clinician, etc). This will not be used for the CATT Study. The second and final statistics column displayed here, Audit Summary, displays a basic audit trail of the data entry and most recent activity on a selected CRF. The top portion shows who initially created the CRF based on their unique login and also shows the date and timestamp for when the CRF was created. The bottom portion shows the most recent modifications date and timestamp, the most recent transactions date and timestamp, and who performed either of these functions.
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Visit drop down option, provides the statistics and summaries for a selected visit tab (click on the visit tab at the top of the spreadsheet):
The first statistics column displayed here, # Patients, details the number of patients s who have been entered for the selected visit (in this case visit 000, selected from the Visit Tab at the top of the spreadsheet). The second statistics column displayed here, Summary of CRFs Retrieved, gives an overall snap shot of the number of CRFs that have been data entered for this study. Planned / Unplanned lists the number of CRFs that are planned (part of the visit schedule) and Unplanned (any collected data that is not part of the approved visit schedule for this study). With active descreps / with other discreps / clean details the number of open discrepancies and the number of cleaned / corrected CRFs. Not verified / Awaiting re-verification / Verified details the number of CRFs that have not been and have been validated, and also the number of CRFs in the process of being re-verified. This will not be used for the CATT Study. Not approved / Awaiting re-approval / Approved details the number of CRFs that have not been and have been approved by a designated approver (PI, Clinician, etc), and also the number of CRFs in the process of being re-approved. This will not be used for the CATT Study.
The third and final statistics column displayed here, Summary of CRFs in Current Tab, gives a snapshot of the number of CRFs that have been data entered for a selected visit (in the example above, visit 000). The categories listed in this column are similar to the categories listed in column two; however, the metrics in column three pertain only to the selected visit.
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Oracle Clinical Remote Data Capture Printing Case Report Forms (CRFs)
Prior to seeing a patient in the clinic, the user should print Case Report Forms (CRFs) from the CATT Main Landing Page, or make copies of existing blank CRFs 4 . CRFs can be printed from the CATT Landing Page: This is the preferred method of printing for this study, as the CRFs will be arraigned in packets by Visit Week. CRFs can also be printed directly from RDC in two different ways: Visit specific pdfs from the Links tab Individual pdfs from a current pdf
Prior to printing, check with your local administrator to insure that your computer has been setup to print to your local printer as your default printing option. Also check to make sure that Adobe has also been configured to print to your default printer.
If the user makes copies of existing blank CRFs, they need to verify that they are using the most current / approved CRFs for the study. Oracle Clinical Users Manual Page 47 of 137
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1.
Printing Case Report Forms (CRFs) as pdfs from the CATT Landing Page. This option provides a hyperlink to take the user to a secure internet portal, which will allow the user to select and print specific blank CRFs for a given visit, as well as, visit packets. NOTE: This is the preferred method for printing CRF Visit Packets for this study. To Print visit specific CRFs as pdfs, navigate to the CATT Landing Page and select the hyperlink titled CATT Case Report Forms by Visit or CATT Case Report Forms Individual, as shown below:
CATT Case Report Forms by Visit will provide the user with Visit Packets for each of the study weeks. CATT Case Report Forms Individual will give the user access to individual CRFs arraigned by category: o o o o o o Insert CRF Forms PRN Forms Ongoing Logs Retain At Clinic Fax to Coordinating Center Submit to Fundus Photograph Reading Center
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1a. To open the CATT Case Report Forms (CRFs) by visit, click on the link CATT Case Report Forms by Visit from the CATT Main Landing Page, and the following page will appear:
All of the Visit Packets for the duration of the study can be accessed by clicking on any of the hyperlinks listed above currently Week 000 Week 084 are displayed, by using the scroll bar to the right of the screen, the user can access the remaining weeks.
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When a packet is opened, the first page will contain a data processing coversheet. This sheet will provide some general instructions about the packet, associated forms, and procedures.
In the example above, Week 000 All Baseline Forms was opened; the first page presented is the Baseline Data Processing Cover Sheet. This sheet provides some general information about the baseline packet: o FORMS this column lists all of the forms provided in the packet. However, any forms listed under the subheadings Insert CRF Forms, PRN Forms, Ongoing Logs, Retain at Clinic, Fax to Coordinating Center, or Submit to Fundus Photograph Center are use as needed forms and must be accessed from the CATT Case Report Forms Individual hyperlink from the CATT Main Landing Page. ADDITIONAL REQUIREMENTS this column will list any additional procedures that are required at a given visit for example Week 024 All Follow-Up Forms has additional requirements, see example on the next page:
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The final portion on all Data Processing Coversheets:
REVIEW COMPLETED CRFs & ENTRY this section at the bottom of each Data Processing Cover Sheet should be used for Quality Control (QC) / Quality Assurance (QA) purposes. It should capture who reviewed the completed forms prior to data entry, who performed the data entry, the dates these activities were performed, and provides space for any comments about quality, problems, or notations.
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These PDFs packets will allow users to enter the CRF header information, and will allow the forms to be populated with patient specific data. Once the PDF is open, click on the Hand Icon:
Move the Icon next to the header word ID. No. to begin typing.
After entering the ID No., hit tab and the cursor will automatically move to Alpha Code. Enter the Alpha Code and hit tab. Enter the Clinic # and hit tab. Enter the Site # and hit tab. Finally Enter the Week and hit tab. The header information will then populate across all of the forms in the pdf packet. Print the packet and the pages will be printed out with the header information prepopulated on the form. o o To print the pdf, click on File from the tool bar and select Print, or Click on the printer icon.
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1b. To open the CATT Case Report Forms (CRFs) by visit, click on the link CATT Case Report Forms - Individual from the CATT Main Landing Page, and the following page will appear:
This page contains hyperlinks for all of the Individual CATT CRFs, which are listed under the following subheadings: o o o o o o Insert CRF Forms PRN Forms Ongoing Logs Retain At Clinic Fax to Coordinating Center Submit to Fundus Photograph Reading Center
These Individual CATT CRFs are not included in the Visit Packets, and should be printed as needed.
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The Individual CATT CRFs are accessed by clicking on the hyperlink listed under the subheading. In the example below, Additional Information on Women of Childbearing Potential Form was selected:
Just as in the example of the CATT Visit Packet, the header of this form has been enabled with the auto-populate feature. o Follow the same directions for typing in the header information (ID. No., Alpha Code, Clinic #, and Week), and then print the form.
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2.
Printing Case Report Forms (CRFs) from an open pdf within Oracle Clinical. After opening a pdf for Data Entry within RDC from the main spreadsheet view, the user can print the pdf, by clicking on the printer icon in the pdf tool bar, outlined below.
The user will only be able to print the CRF they currently have open.
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Oracle Clinical Remote Data Capture Accessing Study Tools Adverse Event Coding and Concomitant Medication Coding
This section will describe how to use the CATT Main Landing Page to perform all of the following study related activities: Accessing External Links for Adverse Event Coding Accessing External Links for Concomitant Medication Coding Report access and printing of a Patient specific reports Visit Schedules and Randomization Assignments
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1. Accessing External Links for Adverse Event Coding, will give the user information that should be recorded on a paper Adverse Event form prior to completing data entry in the Oracle Clinical Remote Data Capture (RDC) interface. Important Note: This link will access a web page outside of Oracle Clinical Remote Data Capture (RDC). This link is maintained by the National Institutes of Health (NIH). Problems arising from connectivity, usage, or performance cannot be addressed by members of the CRCU, CPOB, nor the CC. Help and Support for this page can only be supplied by NIH via their help menu located on the screen. To access the external link for Adverse Event Coding, navigate to the CATT Main Landing Page. Search for the hyperlink titled Adverse Event Coding Reference Tool (NIH) and click on this link to launch the Common Terminology Criteria for Adverse Events (CTCAE) guide provided by the NIH:
The main page of the Adverse Event Coding Reference Tool (NIH) page will open in a separate browser window.
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The CTCAE guide allows a user to search by Category, or by term (both literal and keyword searches), see outlined below.
Category searches can be completed by clicking on the down arrow next to the word All Categories. The user will be presented with a drop down list of body systems. If a body system is selected, the most common ailments will be presented and the user can scroll through the various conditions.
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Term searches can be completed by typing text into the Search for field. This type of search will allow you to search for a Literal or Keyword term. Keyword searches will search for the term entered across multiple fields, checking for the term in name fields, body systems, categories, and descriptions. This type of search will return any items matching the keyword term entered.
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In the example above, Headache was entered as the term. The Keyword button was toggled a list of items were returned. By clicking on the item that matches the Adverse Event in this case, retinoic acid syndrome the CTCAE will retrieve a description and provide grading criteria, see example on next page.
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This description is very important in helping to code, grade, and enter the Adverse Event (AE). If this is the Adverse Event the user wants to use to describe the event, write down the following: o o o MedDRA Code Number. MedDRA Short Name. MedDRA Grade.
These items will then be entered from the paper copy of the Adverse Event Recording Form into RDC. If this description does not match the Adverse Event the user wants to use, try searching again or use the Literal search option. Remark is a very important field, as it contains descriptive data that can help the user make a determination as to whether or not the AE selected appropriately describes the condition.
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Literal searches will search for the term entered in the name fields.
In the example above, Headache was entered as the term. The Literal button was toggled a list of items were returned. By clicking on the item that matches the Adverse Event in this case, Flu-like syndrome the CTCAE will retrieve a description and provide grading criteria, see example on next page.
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Just as in the example with the Keyword search, This description is very important in helping to code, grade, and enter the Adverse Event. If this is the Adverse Event the user wants to use to describe the event, write down the following: o o o MedDRA Code Number. MedDRA Short Name. MedDRA Grade.
These items will then be entered from the paper copy of the Adverse Event Recording Form into RDC.
Repeat the steps for searching for AE terms for all of the AEs that need to be coded.
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The alphabet bar (see below), allows the user To limit the search results alphabetically, click one of the alphabet buttons (that is, #ab, cde, fgh, ijk, lmn, opq, rst, uvw, or xyz) below the Search for field or within the adverse event details (where applicable).
The default is to view all results.
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After obtaining the Adverse Event information from the NIH website, the user can use the auto-populate feature to enter the MedDRA code on the Adverse Event Log within RDC.
Type the MedDRA Code in the column titled MedDRA Code and Tab, the cursor will skip the column titled MedDRA Short Name and will move to MedDRA Grade. After the form has been Saved Complete, the MedDRA Short Name associated with the code entered will be displayed. The AE# field will automatically populate after the form has been saved complete, this feature allows for a user to reference specific events. If there was a typo or transcription error, the erroneous codes will display an error message of Event not found:
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Double-check that the code was entered correctly from the Adverse Event Coding Form, or Return to the NIH CTCAE website and search for the MedDRA Code again
To change the erroneous code, click in the MedDRA Code box. o o Remove the Code for Event not found, then Type in the correct code
A Reason for Change dialog box will open. o o o o From the Reason drop-down list, select a reason for change that best fits the correction reason. An optional comment may be typed in the text box in the example below the reason states Mistyped the MedDRA Code 01jan2008tdc. Click OK Save the form and the correct MedDRA Short Name should now be displayed.
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2.
Accessing Additional Adverse Event Pages Additional Adverse Event Log pages have been provided, and can be accessed from the AE tab. To access additional pages: o Click in the blue box that says Show unplanned pages, outlined below:
The view will change and show 10 available AE pages, outlined below:
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After displaying all available AE pages, the user will need to select the next page, and uncheck the blank flag processing:
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o o o
To activate the page for data entry, click on the CRF Blank check mark, and A Reason for Change box will appear Click OK
After clicking OK, the user will be able to enter data into the CRF
o o
Save the form after entering data. Repeat these steps as needed for additional pages.
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3. Accessing External Links for Medication Coding, will give the user information that should be recorded on the Concomitant Medication form prior to completing data entry in the Oracle Clinical Remote Data Capture (RDC) interface. To access the external link for Medication Coding, navigate to the CATT Main Landing Page. Search for the hyperlink titled Medication Reference Tool (First Data Bank NDDF Plus) and click on this link to launch the Medication Reference Tool.
A new window will open and require the user to enter the same Username and Password, which was entered at the launch of Oracle Clinical RDC.
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After logging in, the Medication Tool Reference search window will be displayed:
This window is divided by 3 sections: o Enter Query Criteria This section allows the user to enter and query for drugs based by either Brand Name, Generic Name, or Drug Code. This section allows the user to sort their query entry by Drug Code, Brand Name, or Generic Name. It is recommended for this study that the User sorts and records events using the Generic Name.
Sort Criteria
Drug Names and Codes This section displays the data queried and sorts it based on the criteria entered by the User.
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To search medications by Brand Name, make sure the radio button next to Brand Name has been selected, then enter the text of the drug to be searched for, and click on the button Execute Query. In the example below we are searching for aspirin:
After the query has returned results, use the scroll bar to search the list for the most appropriate drug name. Then write the code down on the Concomitant Medication Log. This information will then be used to enter the Medication code into Oracle Clinical RDC. Repeat this search as need, based on the medications recorded during the clinic visit. If Brand Name is not working as query, try searching the term using the Generic Name query.
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If the complete spelling of a medication is unknown, the user can enter the first 2-3 characters and % to search for any term that begins with those characters:
This type of search is referred to as a Wildcard Search, and will return any medication in the database that has asp in the Brand Name. Wildcard searches can be applied to the Generic Name and Drug Code search bars.
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To search medications by Generic Name, make sure the radio button next to Generic Name has been selected, then enter the text of the drug to be searched for, and click on the button Execute Query. In the example below we are searching for aspirin:
After the query has returned results, use the scroll bar to search the list for the most appropriate drug name. Then write the code down on the Concomitant Medication Log. This information will then be used to enter the Medication code into Oracle Clinical RDC. Repeat this search as need, based on the medications recorded during the clinic visit.
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To look up, or verify that the correct Drug Code was used, make sure the radio button next to Drug Code has been selected, then enter the code number of the drug to be searched for, and click on the button Execute Query. In the example below we are searching for 1820:
After the query has returned results, use the scroll bar to search the list for the most appropriate drug name. Repeat this search as often as need to look up drug names based on a code number, or to verify that a number correctly matches a drug name.
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After obtaining the Medication Code, the user can use the auto-populate feature to enter the Drug Code on the Concomitant Medication Log (CMED) within RDC.
Type the code in the column titled Drug Code and Tab, the cursor will skip the column titled Medication Name and will move to Rx. After the form has been Saved Complete, the generic drug names associated to the code entered will be displayed.
If there was a typo or transcription error, the erroneous codes will display an error message of Medication not found:
o o
Double-check that the code was entered correctly from the CRF, or Return to the Medication Reference Tool and search for the drug code again
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To change the erroneous code, click in the Drug Code box. o o Remove the Code for Medication not found, then Type in the correct code
A Reason for Change dialog box will open. o o o o From the Reason drop-down menu, select a reason for change that best fits the correction reason. An optional comment may be typed in the text box in the example below the reason states Mistyped the Drug Code 02jan2008tdc. Click ok Save the form and the correct Medication Name will now be displayed.
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4.
Additional Concominant Medication Pages Additional Concominant Medication Log pages have been provided, and can be accessed from the CMED tab. To access additional pages: o Click in the blue box that says Show unplanned pages, outlined below:
The view will change and show 10 available CMED pages, outlined below:
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After displaying all available CMED pages, the user will need to select the next page, and uncheck the blank flag processing:
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o o o
To activate the page for data entry, click on the CRF Blank check mark, and A Reason for Change box will appear Click OK
After clicking OK, the user will be able to enter data into the CRF
o o
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Save the form after entering data. Repeat these steps as needed for additional pages.
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Oracle Clinical Remote Data Capture General Data Entry Instructions

Data Entry is performed from the Main Spreadsheet of Oracle Clinical RDC.
From here, CRFs can be entered, viewed, or updated for registered patients. If a user is entering data for a new patient, they will first need to register the participant (see pages 83-86 for registration instructions). If a user is entering data for an existing patient, they can navigate to the appropriate visit, select either a CRF to complete data entry, or click in one of the white boxes to begin data entry on a new form (see pages 87-95 for data entry instructions).
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The following keys will help explain the icons displayed in the Main Menu Spreadsheet:
Blank an entry status designation that is assigned to a CRF a user has defined as blank. A blank CRF does not contain data, nor can data be collected while it is marked blank. Created an entry status designation that is assigned to a CRF when all required CRF header data has been entered and saved, and no other data (i.e.: response data) has been entered. Entry started an entry status that is assigned to a CRF in which data entry has been initiated but is not complete. CRFs are assigned this entry status because: Some required data fields are complete, while some are not. The CRF has been saved in an incomplete status. Entry Complete an entry status that is assigned to a CRF in which all required fields have been entered, including CRF header fields and Question area response datapoints.
Active a discrepancy status that indicates the relevant discrepancy is actionable by members of the user group.
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1.
To register a patient for the first time: Click on the plus sign beside the site name from the Activity List. A branching diagram of all assigned patient positions for that site will be displayed. Click on the patient you wish to begin data entry for. A hyperlink titled Begin New Data Entry for Patient # # # # # will appear in the Task Pane, in the example below Patient 55100 has been selected.
By clicking on the hyperlink, the user will be taken to the Main Spreadsheet view of RDC and can begin data entry.
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1a.
After the first patient has been registered at a site, further patients can be added by: Clicking on the icon of the Person with a gold star, or Clicking on Insert from the drop down tool bar menu, and select Patient, or Clicking on a blank white rectangle (or selecting the next available patient position) in the patient section of the spreadsheet.
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1b.
After using one of these options to insert a new patient, a small window will appear that will allow the user to Select a patient to begin data entry:
Click on the drop down box in the Insert new patient window, and a list of available patient numbers will appear:
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Click on the Participant Identification Number that you wish to create / enter data for, and the system will automatically insert the patient and open up all of the study visit CRFs for data entry:
In the example above, patient 30100 has just been inserted and all associated study visits are now available for data entry.
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2.
To enter planned CRF data for a patient: Click on an existing CRF icon, or Click on a white box within the Oracle spreadsheet whose coordinates intersect based on patient number and CRF name.
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2a.
To enter a new CRF, click in one of the white boxes, an icon with just a header will appear, and a separate pdf applet will open for data entry:
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RDC tool bars available from the pdf screen:
The buttons outlined above in yellow should be used to help make data entry, browsing, or updating of data easier for the user: o Save Use this button to save any data that has been entered into the CRF. (See page 94 for a description of the different Save Functions)
Close Use this button to close the current pdf. NOTE: Only one CRF can be open by a user at any given time, you must use the close button to physically exit out of the current form. Oracle Clinical will not allow another pdf to be opened if a pdf has not been properly closed, please see message listed below.
Previous Use this button to move to the previous CRF in the visit packet. You will not need to CLOSE the pdf if you use this navigation tool. Oracle will automatically move you to the previous CRF. Next Use this button to move to the next CRF in the visit packet. Again, you will not need to CLOSE the pdf if you use this navigation tool. Oracle will automatically move you to the next CRF. Help Use this button for help topics.
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The buttons outlined above in green can be used to investigate discrepancies, mark a page as blank, and update preferences. In the example above, four of the icons appear faded out. These options Audit History, CRF Navigation, CRF Status, and Annotated CRF are not available for individuals with a data entry role. These options allow data managers, PIs, and designated users the ability to view full audit trail history, change CRF Navigation options, delete or retire CRFs, and view the individual data field names.
The available options from left to right are: Discrepancy Manager This option allows users to view specific discrepancies on the form (for more information see the section of the Users Manual titled: Discrepancy Management). Investigator Comments This option allows users to append a given field and add investigator or other comments to a given field:
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Blank Flag Processing This option allows users to mark an entire CRF or a specific section as blank:
Note: Mark Section refers to question group sections All of the Inclusion Questions on an Eligibility CRF would be an example of a section. User Preference This option allows a user to change some of the basic data entry options:
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Data entry can be completed in a number of ways: Selecting values from a drop down menu called a list of values, or Clicking on an answer with the mouse cursor, or Date fields can be entered manually or by clicking on the pop-up window (as in the example below), or Tabbing from one field to another.
List of Values:
In the example above, outlined in yellow, a list of values is displayed by clicking on the grey box outlined by a blue dashed border. The user can either highlight the appropriate response and press ok; or cancel and type the number of the answer they want in the line to the left of the grey box.
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Another example of a list of values would be: Entry of a visit date: Type the date directly on the line to the right of the word Visit Date, or Click on the grey box outlined by a dashed blue border, which will open a miniature calendar and the user can select the day, month, and year, or If the date of the CRF is the same date of entry, type T on the line to the right of the word Visit Date and todays date will automatically populate.
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Clicking on an answer with the mouse cursor:
In the example above, outlined above, No was selected as the answer by pointing the mouse cursor in the no box and left-clicking.
If the answer should have been Yes, simply left-click on Yes to select that response.
It is also possible to navigate from field to field by tabbing. The user can manually type in answers for fields with a response line, and for those fields with a check box the user can hit the space bar to mark appropriate boxes.
Always remember to SAVE data prior to leaving a form. Data that has not been saved will not be stored, and the user will be required to re-enter that data again.
Save Complete Marks the CRF as being complete. This will run validation and generate queries. Users can still go back to this form to make any necessary updates or changes each change made will require the user to enter a Reason for Change. Save Incomplete This will save whatever data has been entered, and will allow the user to return and complete any missing data elements. This option will not run validation, but will store the saved data. Cancel This option will close this screen and return the user to the CRF page that they were working on. This will not save any data.
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2b.
To enter data into a CRF with the status of entry started, simply click on the page icon to open the form for data entry:
In the example above, there are three different CRF statuses for patient X7 (XYZ): The first box from the left, displays a CRF that only has had its header information entered. The middle box, displays a CRF that has been partially entered. The last box, displays a CRF that has had all data point questions answered.
The first and middle boxes have been Saved Incomplete so that a user can return to it and complete data entry. The last box has been Saved Complete, and can only be updated by an individual who has update privileges. Data Entry for CRFs with the status of entry started follows the same general guidelines as outlined in #3a. o If a form was saved incomplete but all of the answers on the form were completed, the user will need to change at least one item on the form in order to be presented with the save complete option.
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Oracle Clinical Remote Data Capture Discrepancy Management

Discrepancy management refers to a process that systematically addresses discrepancies (queries) generated within a study. Discrepancy management attempts to identify the cause and assess the implications of each discrepancy and determine an appropriate action for the discrepancy. There are two basic types of discrepancies Univariate and Multivariate discrepancies: Univariate discrepancies are discrepancies that are dependent on the value of a single data point. This type of discrepancy is usually triggered when the value recorded for a response does not meet established data entry criteria delineated by the protocol. Multivariate discrepancies are discrepancies that are dependent on two or more data point values, which can be within a single CRF or across multiple CRFs and / or visits. Multivariate discrepancies are triggered when a CRF is saved, which causes the system to run the validation procedures that locate this type of discrepancy. From the Activity List, after a user has first logged in, any open discrepancies for a site or user will be detailed in the Task Pane:
The example above, outlined above, show that the user needs to Review 314 Active Discrepancies for Site CATT 30-1.
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1.
Accessing Discrepancies: Users can either click on the hyperlink: Review 314 Active Discrepancies for Site CATT 30-1, or users can enter the main menu view. By clicking the hyper link, users be given a display that only shows the open discrepancies for this site.
By entering into the main menu view, users will be able to see all data for their site including CRFs with errors and those without (see below).
Active or Open discrepancies are represented by a miniature CRF icon that is shaded in red, see outlined above.
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1a.
To view discrepancies, click on the shaded CRF icon:
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To set all your pdf views to Show Discrepancies: Click on the pdf Preferences icon on the toolbar,
Select the drop-down menu under the Default CRF Highlight area and select Fields with Discrepancies. This will highlight all active discrepancies, like the example on the previous page.
Click on Ok to save the preferences.
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To show the individual discrepancy reasons and error messages: Click on the Discrepancy Manager icon in the toolbar,
Move the mouse cursor to the red highlighted CRF response(s), Left-click the mouse to open the discrepancy description.
In the example above, a discrepancy has been triggered. The discrepancy states that the response cannot be left blank. This is an example of the types of discrepancies that could be encountered during the course of this study. The discrepancy details, including the error message, are shown under the section titled Discrepancy Error Details.
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To be able to access any of the other functions, after using the discrepancy manager cursor, the user must select the Hand icon from the pdf toolbar:
Selecting the Hand icon will allow the user to return to a normal cursor, and will reactive features like: Save, Close, Previous, Next, and Help. Allow the user to use the scroll bar within the pdf. And allow the user to enter data into the individual data points within a given CRF. You will then need to SAVE the page, in order to save the change and rerun validation:
Repeat the above steps to review any active or outstanding discrepancies.
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2.
General instructions for correcting errors: To correct an error, click in the red highlighted field and change the error to the correct or appropriate answer. A Reason for Change pop-up window will appear. Select a Reason for Change from the drop-down menu that best describes why the change is taking place.
There is a text box available for optional change comments.
Click Ok.
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2a.
Discrepancies for sub-questions are at times presented in a hierarchical order, and can be displayed within the same Discrepancy Window. For example, Questions 2a and 2b of the TF form will be displayed within the same window:
When the user clicks on the discrepancy for 2A, they will be presented with the Discrepancy to the left. The Error Message provides the reason the discrepancy was triggered: If Yes, at least one symptom or discomfort must be checked.
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When the user clicks on the discrepancy for 2B, they are presented with a discrepancy window that contains two responses. By clicking on the Tab Open Discrepancy the user can navigate between the two discrepancies (see outlined above). The Question Information box at the top of the page will provide the user with information about the question in the example shown above, the discrepancy is for Question: Was an office visit scheduled? The Error Message provides the reason the discrepancy was triggered: Indicate if office visit scheduled.
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2b.
In some instances, values for given questions will need to be confirmed. For example, the system has built in quality control checks for Race that will cause a discrepancy to be triggered. These discrepancies will need to be resolved in order to remove the red highlight. In the example below, the user is being asked to Confirm the Racial Group entered.
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By clicking on the Discrepancy Manager Icon the user will be displayed with the error message:
In this example, Asian is the correct racial group and the action for this Open Discrepancy will be Close resolved.
A second pop-up window will open and the user will need to provide a Discrepancy Resolution Reason. The user will be required to select a reason from the drown menu. Written comments are optional.
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The user should select an appropriate reason from the list provided.
The user may type in a comment, indicating the reason for change. After clicking OK, the discrepancy will be removed and the response will then become highlighted in green.
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This indicates that the user confirmed the racial group for this subject to be Asian.
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3.
How to create manual queries (discrepancies): Navigate to the question that you would like to update with a manual query. Click on the Discrepancy Manager icon in the tool bar.
Left-click on the question you would like to query. The discrepancy manager pop-up window will open. Make sure you are on the Add Discrepancy tab:
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Select a reason for the discrepancy:
Enter an Error Message and Comment:
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Click Ok, and you will see that the discrepancy is now highlighted in red:
Remember to Save prior to closing or navigating away from this page.
One important note about Manual Queries these will need to also be resolved manually, just like in the example of Confirming Race (pages 105-108). o If an answer is changed for a field with a manual query, it will remain red until the discrepancy has been closed.
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Oracle Clinical Remote Data Capture Randomization, Patient Visit Schedules, and Patient Randomization Reports
This section contains information on how to Randomize patients. This section also describes how the user can access patient specific reports Visit Schedules and Treatment Assignments after a patient has successfully been Randomized.
1.
Patient Randomization: Patient Randomization is accessed via the Week 000 tab from the Main Spreadsheet view.
Access the Randomization Form by clicking in the Rand box for the patient to be randomized. Randomization can only be performed: o o By users assigned with Randomization privilege, and After all necessary Baseline Data has been entered and saved complete with no outstanding discrepancies.
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Answer Questions 1 and 2 appropriately, and save the form complete this will run validation and generate a Randomization Message (see section 4a for a list of Randomization Messages).
In the example below, the randomization was successful. The Randomization Date has populated and the user is given instructions on accessing and printing the Randomization Assignment.
Randomization can only be performed by users that have been designated by the Coordinating Center (CC) to be unblinded. To obtain the Dosing Schedule and Study Drug, the user will need to access the reports as discussed in pages 116-122.
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3a.
Randomization Messages are listed below and depending on outstanding validation rules, incorrect dates, or missing data these messages will be displayed and will need to be addressed in order to successfully randomize a patient.
a. You are not authorized to perform randomizations. Contact the Coordinating Center
immediately if you believe you are a certified Clinic Coordinator. This message is returned if the user has not been assigned the necessary permissions to randomize patients.
b. Eligibility Check Failed: Please review responses to forms with validation errors.
This message is displayed if any of the critical questions on the Baseline forms required for randomization have unresolved errors. The user will need to return to the Main Spreadsheet View, search for any forms with open discrepancies, and address the outstanding validation errors.
c. Eligibility Check Failed: Unresolved Discrepancies Found.

This message is provided if any of the Baseline forms required for randomization have active discrepancies. The user will need to return to the Main Spreadsheet View, search for any forms with open discrepancies, and address the outstanding validation errors.
d. Eligibility Check Failed: Some required Baseline Forms were not entered.
This message is returned if any of the required forms for randomization are missing; or if forms required for randomization have been saved incomplete. The user will need to return to the Main Spreadsheet View, and either enter the missing forms or update and save complete the forms required for Baseline Randomization.
e. Eligibility Check Failed: Time-dependent Checks Failed.

This message is displayed if any critical procedure dates or completion dates for Baseline forms required for randomization have been entered outside of their expected completion windows. The user will need to contact the Coordinating Center for instructions on how to proceed if this message is returned.
f. The patient has been randomized. Go to the Reports section of the CATT Landing Page
for the assignment & treatment schedule: http://rt4.cceb.med.upenn.edu/crcu_html/crcu_rdc_launch.html. This message is provided when the patient has been successfully randomized. The user can now return to the CATT Main Landing Page and access the reports for this patient.
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If Randomization Messages from items b d above are returned, the user will need to check for open discrepancies and resolve the errors, and / or enter any missing CRFs. After the errors have been resolved and all required Baseline forms have been saved complete, the user will need to run validation. To validate a patient, click on Validate and select Patient:
The user will be asked to confirm validation for the patient selected in this case 30150. By clicking OK, the system will run the validation, and update randomization.
While validation is processing, an hourglass or wait cursor will be displayed. After the mouse cursor returns to normal, indicating that the validation process has completed, the user can open the randomization form and retrieve an updated randomization message. Assuming that all errors have been properly addressed, a successful randomization message should be displayed.
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2.
Report access and printing of a Patient Visit Calendar and Randomization Assignment: To access the report link for a Patients Visit Calendar and Randomization Assignment, navigate to the CATT Main Landing Page. Search for the hyperlink titled Oracle Clinical Reports and click on this link to launch the Report Module.
In order to run either of these reports, the patient must first be Randomized by accessing the RAND form, answering all necessary questions correctly, and obtaining a successful Randomization Message. For information on how to randomize, refer to pages 112-116.
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After clicking on the Oracle Clinical Reports from the CATT Landing Page, the following screen will be displayed.
The user will be required to enter their Logon Credentials, in order to access the CATT Standard Reports module, shown below:
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The user will need to enter the PID (ID. No.) and also select the Site ID (Clinic Site) of the patient they wish to view / print a report for, see example below:
After selecting the Site ID from the drop-down box, the Site name will automatically populate in the Site line:
After this information has been entered, the user can access the: Appointment Schedule Report this is the Visit Schedule. o Baseline Treatment Assignment this is the Randomization Report. Repeat the above steps Entering the PID and Site ID for each patient the user would like to access, view, and / or print a report.
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To access and print the Visit Schedule, click on the Appointment Schedule Report button.
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Selecting the Appointment Schedule Report button, will open the report as a pdf document, and can be printed and used as reference.
This report provides the open, expected, and close visit window dates for each of the patients upcoming visits throughout the duration of the study. These dates are calculated based on the date of a patients randomization. o Also listed on this Visit Schedule Randomization Date, Clinic Number, Site Number, Study Eye, and Participant Number.
This form does not impact blinding, and after printing can be maintained in the patients file. To navigate back to the CATT Main Landing Page: o Close the Appointment Schedule by clicking on the red X in the upper right hand corner or by clicking on File and then Exit. The user will be taken back to the CATT Standard Reports menu, where the user can access and print other reports or can exit by clicking Cancel.
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This will bring the user to a grey web page, by clicking on the Back Button the user will be taken back to the CATT Main Landing Page. After navigating back to the CATT Main Landing Page, users will be able to access the CATT Study Tools.
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To access and print the Randomization Report, click on the Baseline Treatment Assignment Report button.
This report can only be accessed by the unblinded Research Coordinator (RC), if a user has not been assigned privileges to access this report the following message will be displayed:
Should a user receive this message in error, they should contact the Coordinating Center (CC) for further instructions.
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Selecting the Baseline Treatment Assignment Report button, will open the report as a pdf document:
This report contains confidential information, and after printing it must be maintained in a secure location to protect the blinding of the study treatment. The report provides information about the patients Randomization Date, Study Eye, Dosing Schedule, and Study Drug. To navigate back to the CATT Main Landing Page: o Close the Appointment Schedule by clicking on the red X in the upper right hand corner or by clicking on File and then Exit. The user will be taken back to the CATT Standard Reports menu, where the user can access and print other reports or can exit by clicking Cancel.
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This will bring the user to a grey web page, by clicking on the Back Button the user will be taken back to the CATT Main Landing Page. After navigating back to the CATT Main Landing Page, users will be able to access the CATT Study Tools.
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CATT List of Abbreviations

AE CATT CC CCEB CDM CMED CPOB CRCU CRF CTCAE DM DMS FDA ICH IE IFPMA INV MedDRA NIH OC OPA OS PC PDF PI PID QA QC RC RDC SAE SOM SP UPENN Adverse Event Comparison of Age-Related Macular Degeneration Treatment Trials Coordinating Center Center for Clinical Epidemiology and Biostatistics Clinical Data Management Concomitant Medication Log Center for Preventive Opthalmology and Biostatistics Clinical Research Computing Unit Case Report Form Common Terminology Criteria for Adverse Events Data Manager Data Management System Food and Drug Administration International Conference on Harmonization Internet Explorer International Federation of Pharmaceutical Manufacturers and Associations Investigator Medical Dictionary for Regulatory Activities National Institutes of Health Oracle Clinical Oracle Project Administration Operating System Personal Computer Portable Document Format Principal Investigator Patient Identification Number Quality Assurance Quality Control Research Coordinator Oracle Clinical Remote Data Capture Serious Adverse Event School of Medicine Service Pack University of Pennsylvania
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Oracle Clinical Glossary 5

A access key The keyboard key corresponds to the letter that is underlined in an items on-screen title. The access key may be activated either singly or in combination with the ALT key. active A discrepancy status that indicates the relevant discrepancy is actionable by members of your user group. active mode In PDF data entry mode, a status assigned to a CRF that allows the user (with appropriate privilege) to modify the CRF. Although multiple CRFs may be open at one time, only one CRF may be open in active mode. audit history The set of all audit records for a given datapoint. audit record A set of information that describes an instance of data update. Each audit record includes the following information: the current value of the datapoint the previous value of the datapoint the username that changed the datapoint the timestamp the data update occurred the change reason an optional comment automatic progression A feature of RDC that enhances user data entry, monitor verification, and investigator sessions. When automatic progression is enabled, as you complete work on the current CRF focus moves to the next CRF in a sequence specified by the settings in the Preferences window. The next CRF may be: within the current patient record, across Spreadsheet tabs; within the current patient, within the current event tab; or within the current CRF column. NOTE: Based on system administrator settings, the Preferences window may not be available in your session
B blank An entry status designation that is assigned to a CRF a user has defined as blank. A Blank CRF does not contain data, nor can data be collected while it is marked as blank. browse 1) A user action that entails reviewing existing data without adding new data or changing existing data. 2) A privilege, specific to batch loaded CRFs, that provides the user with the ability to view existing data, but not to add new data or update existing data in CRFs.
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browse mode In PDF data entry mode, a status that allows the user to work with the CRF as read-only; that is, data entry or update is not permitted. More than one browse mode CRF can be open simultaneously.
C cancel A user action that halts the current process or action and reverts to the state of the application that immediately preceded the process or action, without changing the status of the system or data. cancel button In a dialogue or pop-up window, a cancel button causes the application to dismiss the window, disregard changes made in the window, and revert to conditions that existed before the window opened. case book The set of CRFs that are used to collect data for a patient over the course of the study. Each patient is assigned to a particular case book. case report form (CRF) A paper or electronic record associated with a patient in a study. Its purpose is to facilitate accurate collection of clinical data. CRFs are accessed through the PDF data entry window. change history A listing of the values that have been assigned to data or information. Each list item includes information that uniquely identifies it. Specifically, a timestamp and the username of the person who made the change are recorded. A change history can be associated with the following: response value investigator comment discrepancy Center for Preventive Opthalmology and Biostatistics (CPOB) The Center for Preventive Ophthalmology and Biostatistics (CPOB) leads and collaborates in ophthalmic clinical research through study design, protocol development, comprehensive data management, cutting-edge interpretation of fundus images, statistical analysis, and interpretation of data. change reason A constituent of an audit record. A standardized entry that explains why a datapoint changed. The change reason can be supplied either automatically (system-provided) or manually (userprovided). A user-supplied change reason is required when patient data changes after the CRF reaches entry complete data entry status. clinical planned event (CPE) An occurrence, usually a visit, that is scheduled as part of a protocol to collect clinical data for a patient. CPEs appear under the visits tab in the context of a case book. Clinical Research Computing Unit (CRCU) The Clinical Research Computing Unit (CRCU) is a designated core research facility providing state-of-the-art scientific services related to clinical data management and research computing. The CRCU is staffed with project management, clinical data management, and research computing professionals who support the development and implementation of large-scale, multicenter clinical trials, collaborative clinical and patient-oriented research, and multi-institutional health services research projects for Penn Medicine, which encompasses the CCEB, the School
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of Medicine, and the University of Pennsylvania Health System (UPHS). The development and support activities of the CRCU involve application development, database administration, project management, clinical data management, research computing, and technology support services. closed A discrepancy status that indicates the relevant discrepancy is not actionable by any user group. The discrepancy has been resolved, either by a user or the system.
Common Terminology Criteria for Adverse Events (CTCAE) v3.0 An external link and reference tool designed by the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) and housed on the National Institutes for Health (NIH) web page. The CTCAE was created as a way to categorize adverse events for reporting to funding agencies, FDA, and regulatory agencies; provides for more efficient and universal statistical analysis; and is highly useful in publications. The current CTCAE, v3.0, provides definitions for AE terms and a grading (severity) scale for each AE. The CTCAE v3.0 and its associated grading criteria are very specific, providing an AE term and grade that precisely describes the event and associated body systems. For the latest version of the CTCAE, each AE term is mapped to a specific code from the Medical Dictionary for Regulatory Activities (MedDRA) v6.0. created An entry status designation that is assigned to a CRF when all required CRF header data has been entered and saved, and no other data (i.e.: response data) has been entered. This is used when your internal process involves an administration person who logs the paper as received in-house, but the data have not yet been entered by the DE staff. criterion In reference to the RDC Search Window, one of the components that can be altered so that a certain set of study data is retrieved to the Spreadsheet. Each criterion is comprised of a set of parameters that allow you to make choices about the data you wish to retrieve. The Search Window is comprised of seven criteria: 1. Book criterion 2. Site criterion 3. Patients Subsearch window 4. Visit / Page Range Subsearch window 5. CRF Status Subsearch window 6. CRF / Visit Dates Subsearch window 7. Data Subsearch window Each criterion is comprised of a certain number of parameters. With the exception of the book criterion, all Search window criteria have a default setting that retrieves the maximum amount of data (For example, the default criterion for the Site is All Sites). You modify a criterion form its default by changing one or more of the parameters that comprise it. The Book and Site criteria have a single parameter, which you access and modify from the Search window. All other criteria have multiple parameters, which you access and modify in the Subsearch window that is specific to each criterion. CRF header An area of a CRF which consists of information that identifies a given CRF and the data that it collects. The information pertains to the patient, visit, investigator, and site. Much of the information included in the header is displayed in Patient Workbook Report, which allows you to print a casebook for a specific patient. In the data entry windows, certain fields in the CRF header are required, that is, you must record that information before the system allows you to save the CRF.
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RDC will not save a CRF to the study database until all required CRF header and CRF section header fields are collected. CRF information A field in a PDF mode CRF in which you collect information that uniquely describes and defines the current CRF. Based on the type of information it collects, the field may be required or optional. It correlates directly with a CRF header field. CRF section A constituent of a CRF that is comprised of a set of related questions. Each CRF contains at least one section and may contain more than one. In OC terms, a section equates to a data collection module (DCM). current A discrepancy stat that indicates action can be taken on the discrepancy either by a user or by the system. current study The data set that is active. The name of the current study is displayed in the title bar of the Main Application Window.
D data collection instrument (DCI) The Oracle Clinical term that correlates to an RDC CRF. A DCI is composed of one or more DCMs. data collection module (DCM) The Oracle Clinical term for a CRF section. A set of one or more related groups of questions that pertain to a single clinical study visit. data entry mode A designation that describes the method that is used to enter data into a CRF and save it to the study database. data entry status A designation that describes the current state of data entry for a CRF. There are four data entry statuses: 1. created 2. blank 3. entry started 4. entry complete data field A location in the Question area of the Data Entry window in which you type a value that is the response to a CRF question. data point A location in a form where a data value may be entered. In most cases, a data point corresponds to a field in the data entry window. data selection tool Either of two components that allow you to specify the patient data you want to include in a workset. The Search Window, which is available to all users, provides the capability to specify parameters that can result in narrowly defined worksets. The Activity List window, which is made available by the administrator, defines the workset indirectly, based on the activity the user selects.
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data update The process of changing a CRF that has been created and saved to the database by altering a data point and saving the new version of the CRF to the database. default search The saved search that is designated to be used as the default search criteria for the Search window and the default filter for the Activity List window. default study The preferred study associated with your username. discrepancy Data that falls outside of an expected range of values or is otherwise flagged during the edit check process. discrepancy action A process that changes the status of a discrepancy. There are two types of actions: 1. routing 2. resolution discrepancy change history The listing associated with a discrepancy that provides details of each update that was made. The specific components of the discrepancy change history are: 1. timestamp of update 2. error text 3. discrepancy comment 4. current status 5. resolution 6. resolution comment 7. change by discrepancy management A process that systematically addresses discrepancies generated within a study. Discrepancy management attempts to identify the cause and assess the implications of each discrepancy and determine an appropriate action for the discrepancy. Its goal is to satisfactorily resolve all discrepancies associated with each CRF. discrepancy record An entry which is part of the study database that defines the pertinent aspects of a discrepancy, from its initial occurrence and through each action that is taken on it. discrepancy status A designation that describes the current state of a CRF with regard to discrepancies. There are four discrepancy statuses: 1. none 2. closed 3. active 4. other discrete value group (DVG) A set of responses that are acceptable for a given question. A DVG constrains the responses to a question to a distinct set of values. It may also allow the same question to be used in multiple instances. It is also possible for one DVG to be a subset of another DVG. In this case, the child DVG is mae up of responses that are part of the parent.
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E electronic data capture (EDC) A method of data collection for studies that uses computers at investigator sites as a mechanism to submit patient data and information to a centralized study database. Remote Data Capture (RDC) is an electronic data capture application. entry complete An entry status that is assigned to a CRF in which all required fields have been entered, including CRF header fields and Question area response datapoints. entry started An entry status that is assigned to a CRF in which data entry has been initiated but is not complete. CRFs that are assigned this entry status, some required data fields are complete, while some are not; the document has been saved in an incomplete status. entry status Formal stages of data entry, delineated in RDC, that track the progression of a CRF from no data entered (created) through entry complete.
F filter A saved search that is applied to the Activity List window to limit the scope of the Navigation page and / or the activities that are available in the Task pane. It allows you to generate a more discrete and focused workset that is still based on an activity. focus Where the cursor is currently active. Focus may change from window to window, as when the cursor moves from the Main Application window to the first data field in the Data Entry window when you click a CRF cell. frozen A designation that is applied to a patient which indicates that all data has been received, entered, reviewed, and cleaned for a patient, CRF, or visit.
H header field A location in the CRF header in which you collect values that provide information about the CRF. All required header fields must be collected before the system permits a CRF to be saved to the study database.
I indicator question A question used with certain question groups that allows branching during data entry based on the response. For example, in a Drug Allergy question group, an indicator question could be, Are you allergic to any drugs? If the response is Yes, the remaining questions in the question group, such as Drug Name and Type of Reaction, require responses If the response is No, the rest of the question group is not collected.
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L list of values (LOV) A set of possible values for a data field. The list of values can generally be displayed by either clicking the button associated with list of value fields, pressing the List button, or by pressing the F9 key. locked A status assigned to a CRF that indicates all data has been collected, approved, and verified. A locked CRF may be viewed in browse mode, however, its data may not be updated under normal circumstances.
M manual discrepancy A discrepancy that is generated by a user, rather than a data point value. A manual discrepancy may be associated with an entire CRF, a CRF header, or a specific response in the question area of a CRF. MedDRA The Medical Dictionary for Regulatory Activities is a pragmatic, medically valid taxonomy of medical terms with an emphasis on ease of use for data entry, retrieval, analysis, and display, as well as a suitable balance between sensitivity and specificity within the regulatory environment. It allows for uniform coding and reporting of medical signs, symptoms, and body systems for Adverse Event (AE) reporting. It was developed by the International Conference on Harmonization (ICH) and is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) acting as trustee for the ICH steering committee. multivariate discrepancy A discrepancy that is dependent on two or more data point values, which can be within a single CRF or across multiple CRFs and / or visits. A multivariate discrepancy is generated when a CRF is saved, which causes the system to run the validation procedures that locate this type of discrepancy.
N navigation pane In the Activity List window, the section, or frame, that comprises the left-hand portion of the window and presents a hierarchical listing of the current study e.g. the patients assigned to each site are displayed under the site name. news item A message that is communicated by the study sponsor to some portion of its RDC users. News items are displayed in the News window. node An item in the hierarchical tree in the navigation pane. When you select a node, the tasks that are associated with it are displayed in the task pane. Each node represents one of three scopes: study, site, or patient. Within the navigation pane, there is only one study node displayed. However, depending on the security settings associated with your username, there may be more than one Site node displayed under the Study node, and generally many Patient nodes listed under each Site node.
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O obsolete A system-generated discrepancy state assigned to a discrepancy that is associated with a response that is a constituent of a: repeating question row that was deleted a question that was deleted a CRF section that was deleted a CRF that was deleted
A section discrepancy is made obsolete when its parent CRF is deleted or made blank. A data discrepancy is also made obsolete if the validation procedure upon which it is based is retired. open A designation for a discrepancy that indicates it is either in the active or other discrepancy status; that is, it is actionable by a user group. A designation for a CRF that indicates it contains at lease one active or other discrepancy.
P parameter A component of a criterion that you use to define a specific property of the data you wish to comprise the workset. A parameter may be comprised of settings that represent a value or range of values that, when combined with any other parameters in the same criterion, define specific data. patient A human participant in a study. In RDC about whom data is collected. Each patient in a study is assigned a unique patient number that is associated with a particular site. In addition, the patient number is also assigned to a particular case book. patient data The data that is collected about a participant in a study. This includes demographic information and clinical results. patient list The set of patients that contain at leas one CRF which satisfies the search criteria. patient number A designation for a set of patient data that is unique across a give study. Patient numbers are assigned to a study as part of the design process. Alternative terms include patient positions, enrollment number, allocation number, and randomization number. The following rules apply to all patient numbers: 1. Each patient number must always be assigned to a site. 2. Each patient number may not be assigned to more than one site at a time. 3. The first character in the patient number string may be a non-zero numeric or an alphabetic character. 4. If the first character in the patient number sting is alphabetic, the second character must be a non-zero character. 5. Only the first character may be alphabetic.
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pending changes Changes that are made to a CRF that have not yet been committed to the study database. The changes that may be pending are response value, investigator comments, or discrepancies. The save action commits pending changes to the database. privilege The ability for a user to perform a certain task. Privileges are granted to users in the Administration study and site maintenance windows by administrators. In general, users within a user group, that is, those that are given the same role, are assigned the same set of privileges. progression sequence The order that RDC uses to navigate to and open CRFs. There are three different modes available: 1. By patient 2. By patient, within Spreadsheet view (classic mode only) 3. By CRF column The specific sequence that is employed at any time is defined by the Progression to next CRF setting in the Preferences window. In PDF mode, the browse sequence is invoked when you use the Previous and Next buttons.
Q query A term that is a synonym for discrepancy. A procedure that is run against a database with the goal of returning a subset of data that satisfies the query criteria. question group (QG) A set of questions in a CRF that are related due to similarity or study protocol considerations. An example of a question group is Demographics, which collects such data as: sex, race, and date of birth. question name The label that describes a question. It may be in the form of a question or it may simply be a word or phrase that serves as the prompt for a response.
R resolution A type of discrepancy action that causes the status to change from active to closed. resolution reason A parameter associated with a discrepancy action that provides a reason when a user closes a discrepancy. response value The value that is assigned to a datapoint. This term usually refers to the fields in the Question area of a CRF. response sequence The order in which the system expects data to proceed, from one field to the next. Also termed Tab Order, this is determined for each question during the CRF design of study setup. It is utilized when you use the Tab key to navigate from one field to another.
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S save An action that commits pending data changes to the study database. In PDF mode, all save actions are explicit, initiated by the user clicking the Save button or choosing to save pending changes through the save edits / exit window. save complete A save action that causes RDC to assign the CRF to the entry complete data entry status. save incomplete A save action that causes RDC to assign the CRF to the entry started data entry status. Search window A component that allows a user to define directly the search criteria that is displayed in the RDC Spreadsheet. The Search window provides access to seven criteria, which can be modified from default values that the system combines to retrieve CRFs from the study database. session The period that starts when you successfully log in to RD and ends when you exit RDC. It is constricted by limitations that are imposed by the following conditions: only one username is granted access to a session the role and privileges assigned to the username determine the patient data and functionality that is available within a session only one database can be accessed during a given session if you want to access a different database, you must initiate a new RDC session only one study can be open at a time during a session, however, unlike the restriction on the active database, you can change to another study within an RDC session if you want to access a different study you must close the current study and select another only one book can be active at a given time, however, you can change to another book within an RDC session one or more sites can be active during a given session and the privileges assigned to the username may vary from site to site site A clinical location that participates within a give study.
T task pane In the Activity List window, the section, or frame, that comprises the right-hand portion of the window and presents a listing of activities, or tasks, associated with the currently selected node in the navigation pane. When you click a task, RDC retrieves the data necessary to complete the task from the study database and displays it in the RDC spreadsheet. timepoint A significant even in the history of a CRF. Used as criterion when viewing the Audit Trail tab. Examples of timepoints include: creation date verification dates approval dates timestamp A value assigned to a datapoint that provides a chronology for significant events during a study. Such events include: the date / time when a value was created, the date / time when a value was updated, etc.
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U univariate discrepancy A discrepancy that is dependent on the value of a single data point. This type of discrepancy is usually when the value recorded for a response does not meet certain criteria that has been deemed acceptable by the PI, protocol, or study sponsor. unplanned A designation attributed to any even or CRF that was not part of the protocol schedule or which occurs at a time other than was originally specified in the protocol schedule.
unplanned CRF A CRF collected at a visit at which it was not planned, that is, it is not part of the case book. unplanned visit A clinical event which occurs that was not scheduled by the protocol.
update A process or condition in which CRF data or information, which has previously been saved is changed. A privilege that allows a user to initiate data entry, update data, initiate discrepancies, and update discrepancies. user group A set of users that are assigned to the same user role. user role A database role that is granted to a user or user group. There are five default user roles, however, any given study database may include some or all of these, and may include protocoldefined roles. RDC allows privileges to be assigned independently of user role assignment.
V validation An action that entails the initiation and processing of sponsor-defined procedures, in the case of multiple datapoints, or edit checks, in the case of a single datapoint, that analyze collected data and return a query, or discrepancy, for each datapoint that does not meet the criteria defined in the procedure. Such a data-generated discrepancy is also referred to as a validation error. validation error A condition associated with one or more datapoints that indicates the value does not meet the criteria defined in a question definition or validation procedure. It is equivalent to a datagenerated discrepancy. value When used in the context of criteria and parameters, the choice that you assign to a parameter, which was chosen from a list of possible values. visit A clinical even, which generally denotes the occurrence of a meeting between a patient and clinical staff at a study site. In the course of a visit, data related to the study is collected, which at some point is recorded and saved to the study database.
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In RDC, a visit consists of one or more CRFs. By default, the system displays Spreadsheet Visit view in the RDC Workspace, which displays, for the current patient list, all of the CRFs collected for a single visit.
W workset The collection of patient data that is currently displayed in the RDC Spreadsheet. You use either the search window or the Activity List window to select the data that you want to view in the Spreadsheet. This may include, but is not limited to, the following: patients CRFs, including entry, approval, verification, and lock statuses response data investigator comments discrepancies audit trail history This term may also be called a dataset.
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Oracle Clinical Remote Data Capture Installation and Getting Started

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After click Yes, the download will proceed.

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Oracle Clinical Remote Data Capture Logging-In

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Oracle Clinical Remote Data Capture Navigation and General Overview

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2. The next screen is the Activity List screen, displayed below.

Oracle Clinical Users Manual

In the example above, none of the patients have been registered.

Oracle Clinical Users Manual

Oracle Clinical Users Manual

The Task Pane of the activity list is outlined below.

Oracle Clinical Users Manual

The Search Window of the activity list is outlined below.

Oracle Clinical Users Manual

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