Clinical Data Management

by
T V S Sarma
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What is Clinical Data management ?

Clinical Data Management is the process of ensuring that the data colleted
during a clinical trial is …
 Accurate : perfect conformity to fact or truth ; strictly correct
 Complete : Having every necessary or normal part
 Logical : Legitimate
 Consistent : The same, throughout in structure or composition

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Goal of CDM

To provide complete quality data ‘timely.’

Quality data is defined as ‘data that sufficiently support

conclusions and interpretations equivalent to those derived
from error free data.’

Achieved by ensuring that ...

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…goal of CDM

 The collected data is complete and accurate so that the results are correct.
 The trial database is complete and accurate, and a true representation of what took
place in the trial
 The trial database is sufficiently clean to support the statistical analysis, and its
subsequent presentation and interpretation

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Why CDM ?
What ICH GCP Guidelines say

All clinical research data should be recorded, handled, and stored in a

way that allows its accurate reporting, interpretation and verification
(GCP 2.10)

Quality assurance and quality control systems with written standard
operating procedures should be implemented and maintained to ensure
that research are conducted and data are generated, documented and
recorded, and reported in compliance with the protocol, GCP and
applicable regulatory requirements. (GCP 5.1.1)

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…what ICH GCP Guidelines say

Systems with procedures that assure the quality of every aspect of

the research should be implemented (GCP 2.13)

If data are transformed during processing, it should always be
possible to compare the original data and observations with the
processed data (ICH GCP 5.5.4)

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Why CDM ?
Some technology challenges

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 Why CDM ?
Compliance

Compliance with 21 CFR part 11: security, audit trail, version control
 Validation - accuracy, reliability, consistent intended performance and the means to discern
invalid or altered records
 Restriction of system access to only authorized individuals

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…compliance

 Secure, computer-generated, time-stamped audit trails to record operator

entries and action to create, modify and delete electronic records –
retained for required period and available for agency review and copying
 Operational system checks to enforce permitted sequencing of steps and
events as appropriate

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Relevant Standards
CDISC

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CDMS

Clinical Data Management System

… Paraphrasing, we can define it as a system for management of clinical data, where
…

System means both the hardware and software

Clinical Data, refers to any textual, graphical, audio, pictorial data acquired during a
clinical trial

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Potential for problems

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Activities involved in Data Management

1. Scanning the source documents and tagging the source data with
electronic format
2. 21 CFR Part 11 requirement analysis
3. Preparation of Data Management Plan
4. Selection of Digitization tool
5. Creation of data entry screens
6. Creation of edit checks and Data Quality Checks
7. Data security implementation

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…activities involved in Data Management

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The ‘How’ of Data Management
The DMP (Data Management Plan)

What a DMP does

Specifies . . .
 What is the work to be performed?
 Who is responsible for the work?
 Which SOPs or guidelines will apply?
 What documentation or output will be collected or produced?

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DMP continued…

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When does the DM Process start

Immediately after the Protocol has been finalized and approved

This means that a part of the DM team needs to be involved in CRF design

Common mistake : Design CRF without DM process in mind

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CRF Scanning

To ensure compliance with 21 CFR Part 11

CRFs are scanned soon after receipt in the CRF Tracking system
and archived electronically into an image Database.

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CRF Scanning

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Database Design

Database is Designed and the relevant entities like Database

Tables, Procedures, Validation programs are created in the Selected
Software like Oracle

Data entry screens are created such that they closely resemble the
Paper CRF.

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Data Entry and Verification

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Data entry and verification

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Data Validation/Edit Check

Consists of computer Checks on the Data to ensure the Validity and

Accuracy of Data

Validate Data against predetermined Specifications

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Types of Checks?

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Data Analytics

Preparation of Statistical Analysis Plan (SAP)

Creation of Data Marts

Creation of Tables and Listings

Performing Statistical Analysis using SAS

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…Data Analytics

Analysis of Pharmacokinetic, Epidemiological and Clinical Trial Data

Clinical Report generation

Creation of Domain Sets as per CDISC SDTM

Regulatory submission using SAS

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Database Closure

Points to be considered in database closure preparation include the

following:
1. All data have been received and processed.
2. All queries have been resolved
3. External data (e.g. electronic laboratory data) are reconciled with
the study database and are complete
4. If a separate, serious adverse event database exists, it is
reconciled with the main study database

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Database Closure…

5. The coding list has been reviewed for completeness and consistency.
6. Final review of logic and consistency check output has taken place.
7. Final review for obvious anomalies has taken place.
8. Quality audit of the data and documentation of the error rate have
occurred.
9. All documentation is updated and stored where required by Standard
Operation Procedures.

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CDMS Solutions

Data Analytics: SAS

EDC: Oracle Clinical, Phase Forward

Document management services: Documentum, Adobe

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