Clinical User Guide

Clinical Quick Reference Guide 3
Welcome to the ELVIS Quick Reference Guide. When you are completing your CV,
you will be guided through the tabs at the top to complete. There will be four
different types of fields:
Field Type Description
Mandatory Free Form Fields mandatory These fields you are required to enter
fields will be indicated by an (*). information for, but the information that
you enter will be typed into the open
field.
Mandatory Drop Down Lists, mandatory These fields are also required, but you
fields will be indicated by an (*). will make your selection from a drop
down menu.
Optional Free Form Fields These fields are not required, and the
information that you enter will be typed
into the open field.
Optional Drop Down Lists These fields are not required, and the
information that you enter will be typed
into the open field.
The remainder of this document will walk you through the process tab by tab.
Employee
Mandatory Free Form Fields

Field Business Unit Requirement
Overall summary of clinical trial experience to date. See sample text
below. Example: CTL
Since (enter year) in Clinical Research. Strong background in clinical
monitoring experienced in all aspects of project phases from site
Summary selection to close-out in X, Y, Z therapeutic areas. Experience in Clinical
Project Management since (enter year) of international teams of
monitors (across different geographic regions - enter applicable
regions?) to ensure timely delivery of clinical part of trial to expected
quality, using agreed systems and tools.
Optional Free Form Field
Enter when applicable (Msci/MSci, PhD, MD, BS/BSc, MPH, PMP,
Certification Suffix CCRA, CCRC, RN etc). If you have multiple degrees, i.e. Msci and
PhD enter ONLY the highest certification.
Formal Education History

Institution Name Enter name of academic institution
Education Enter applicable (MSci, PhD, BA etc), Nurse (type A, B, C), Physiotherapist
Level/Degree OR any professional degree (non-academic)'.
Area of Study Pharmacy, Medicine, Chemistry, Biology, Nursing, Business Administration,
etc
Mandatory Drop Down List
Country Select from drop down
Click on Value cell and choose from drop down list. "Attended- not
Completion Status Completed" means you interrupted your courses at certain point. "In progress"
means that you are actively following your courses with intention to complete.
Last Date Attended Complete only when completion status has a "Completed" or "Attended -not
completed" value. Enter your education information from most to least recent
Quintiles Employment History

Job Title The job title you enter in this field should be your job role.
Please don’t use abbreviated titles. Example: Clinical
Research Assoc rather than CRA/CRA 1.
The title is written in the drop down as Clinical Research
Assoc.
Key Responsibilities Please complete this field by using the text from the
Responsibilities section of your job description which is posted
on QZONE. Note there is a 2,000 character limit per entry.
You can copy and paste directly from the job description into
the CV template. Change to past tense for all roles except current
position.
http://hrcareer.quintiles.com/CareerManagement/JobDescripti
ons/Pages/Default.aspx. Do not create original text.
Cooperate closely with Project Manager and other project leads.

Select from calendar. Current job title should be first entry. If multiple roles
Start Date within Quintiles, last entry will more than likely be the date of employment at
Quintiles.
Complete only if you have another formal title apart from your Job title. If
Business Title
unsure please check with HR to confirm.
Select from calendar. Current job title (s) will not have an end date (s). All
End Date
previous entries will have an end date.
Non Quintiles Employment History

Name of Employer Full company name - do not use abbreviations
Job Title As used by former employer, full name, do not use abbreviations
Should be the same convention for description - CRA, CTL, SSU, LM, etc. as
for Quintiles employment, use past tense, as these responsibilities pertain to
Key Responsibilities employment preceding Quintiles. Limit responsibilities to key/major
responsibilities of previous role. Enter most to least recent for previous
employment. Enter as past tense.
Start Date Select from calendar
Optional Drop Down List

End Date Select from calendar
Quintiles Clinical Trial Experience

Please complete this field by using the text from the
Responsibilities section of your job description which is posted
on QZONE. Note there is a 2,000 character limit per entry.
You can copy and paste directly from the job description into
the CV template.
http://hrcareer.quintiles.com/CareerManagement/JobDescripti
Key Responsibilities ons/Pages/Default.aspx
Example: if a Sr. CRA is acting as a support of the CTL on a study, the key
responsibilities are needed to be detailed. Other example: if a CTL is acting
as a Report Reviewer, the key responsibilities are to be detailed. If a CTL is
acting as a CTL, only the coverage should be detailed, for example: Regional
CTL; LatAm CTL for Brazil, Chile and Peru; Global CTL.
Select from drop down. This should be completed as this field is for internal
purposes only and will not appear on the external CV document. For
Customer Customers that don’t match any of the drop down choices,
please use the option of OTHER. The list is currently being
finalized and will have updated options in the future.
Study Phase Select from drop down
Select from drop down. For indications that don’t match any of the
drop down choices, please use the option of OTHER. The list is
Indication
currently being finalized and will have updated options in the
future.
Enter your job role. This should match what you have entered
Role for your job title on the previous Employment tabs.
Example: NOT CRA or CRA 1, but Clinical Research Assoc.
# of Countries Not required
# of Sites Not required
# of Patients Not required

Special Population Select from drop down (Not required for North America)
Drug Class Select from drop down
Start Date Enter date you started on trial
End Date Enter date you completed the trial/transferred responsibility

Non Quintiles Clinical Trial

Experience

It should not be redundant in cases when the role in the study is different than
the job title. Example: if a Sr. CRA is acting as a support of the CTL on a
study, the key responsibilities are needed to be detailed. Other example: if a
Key Responsibilities
CTL is acting as a Report Reviewer, the key responsibilities are to be
detailed. If a CTL is acting as a CTL, only the coverage should be detailed, for
example: Regional CTL; LatAm CTL for Brazil, Chile and Peru; Global CTL.
Study Phase Select from drop down
Select from drop down. For indications that don’t match any of the
drop down choices, please use the option of OTHER. The list is
Indication
currently being finalized and will have updated options in the
future.
Enter your job role. This should match what you have entered
Role for your job title on the previous Employment tabs.
Example: NOT CRA or CRA 1, but Clinical Research Assoc.
Complete if you can chose one of these: CRO, pharmaceutical, bio-
Industry Type
technology, academic, site
Special Population Select from drop down
Drug Class Select from drop down

Geographic Region Select from drop down
# of Sites Select from drop down
# of Patients Select from drop down
Start Date Date you started in the role

End Date Date you completed or transferred responsibilities
Therapeutic Area Experience

Describe Experience Skip this page
Department Specific Experience

Biostatistics

Click to access the drop down to pick the appropriate department and
All
complete the appropriate experience.
Department Specific Experience –

Clinical
Optional Checkbox
Audits and/or Regulatory Select if applicable
Inspection
Closure Visits Select if applicable
Collection and review of Select if applicable

regulatory packages
Conducting CRA Select if applicable
Training
Conducting GCP Select if applicable
Training
Drug Accountability Select if applicable
eDC Monitoring Select if applicable
Feasibilities Select if applicable
ICF/Study document Select if applicable

development
Initiation Visits Select if applicable
International Project Select if applicable

Experience
Investigator Meeting Select if applicable
Attendance
Liaising with Customer Select if applicable
and/or External Vendors
Line Management of Select if applicable
Clinical Staff
Management of Select if applicable
International Clinical
Team
Management of SAE’s Select if applicable
Monitoring Visits and Select if applicable

Source Data Verification
Query Resolution Select if applicable
Re-Labelling and/or IP Select if applicable

Recall process
Remote Monitoring Select if applicable
Site Contracting Select if applicable
Site Selection Visits Select if applicable
Study Files Maintenance Select if applicable
Submissions to Select if applicable

Regulatory Bodies
and/or to Ethic
Committees
Department Specific Experience

Project Management
# of Years
All Skip this page
Languages

Languages Click on "value" and choose applicable
Speaking Select from drop down
Reading Select from drop down
Writing Select from drop down
Current Memberships in Professional

Organizations

Name of Organization Use full name and do not abbreviate
Publications, Doctoral Thesis

Most current on the top. Journal publications and congress/meetings
Publications
presentations published in abstracts (100 lines max)
Licenses and Certifications

Licenses, Certifications Enter those that are currently valid. 50 lines max
Select from drop down. For certifications that are renewed (ie. annually, etc).
Year
Select the year the initial license/certification was obtained.
Award and Honors

Enter all received - academia, international awards, business awards. Do
Awards and Honors
NOT enter the Work Worth Doing and other Quintiles internal awards
Year Select from drop down
Other

Enter external business courses i.e. negotiations, assertivness, people
Relevant Non-Clinical
management, project management, regulatory, QA/QM, and language
Training
courses.
Please enter any additional relevant experience not captured in other CV
Other
pages.
Additional guidance
Troubleshooting
If you are experiencing issues with the functionality of the ELVIS CV document,
please log a GETIT ticket so we can track and log all queries. This will allow us to
catalogue and resolve in a timely manner for you.
Modifications
Any questions you have on the completion of the CV or any suggested changes
/requirements you have to the CV Form, User guide or Drop downs should also be
submitted via a GETIT ticket and will be managed by the ELVIS CV Governance
process.

Clinical User Guide

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Clinical Quick Reference Guide 3

Mandatory Free Form Fields

Formal Education History

Mandatory Free Form Fields

Quintiles Employment History

Mandatory Free Form Fields

Cooperate closely with Project Manager and other project leads.

Mandatory Drop Down List

Non Quintiles Employment History

Mandatory Free Form Fields

Optional Drop Down List

Quintiles Clinical Trial Experience

Mandatory Free Form Fields

# of Sites Not required

# of Patients Not required

Drug Class Select from drop down

Start Date Enter date you started on trial

End Date Enter date you completed the trial/transferred responsibility

Non Quintiles Clinical Trial

Mandatory Free Form Fields

Drug Class Select from drop down

Geographic Region Select from drop down

# of Sites Select from drop down

# of Patients Select from drop down

Start Date Date you started in the role

Therapeutic Area Experience

Mandatory Free Form Fields

Department Specific Experience

Optional Drop Down List

Department Specific Experience –

Collection and review of Select if applicable

eDC Monitoring Select if applicable

Feasibilities Select if applicable

ICF/Study document Select if applicable

International Project Select if applicable

Monitoring Visits and Select if applicable

Re-Labelling and/or IP Select if applicable

Site Contracting Select if applicable

Site Selection Visits Select if applicable

Study Files Maintenance Select if applicable

Submissions to Select if applicable

Department Specific Experience

Mandatory Drop Down List

Current Memberships in Professional

Mandatory Free Form Fields

Publications, Doctoral Thesis

Mandatory Free Form Fields

Licenses and Certifications

Mandatory Free Form Fields

Award and Honors

Mandatory Free Form Fields

Optional Free Form Field

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