Clinical Data ManagementbyT V S Sarmafor more information: info@cdmathome.comfor more information: info@cdmathome.com

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� 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.’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 tookplace in the trial

� The trial database is sufficiently clean to support the statistical analysis, and itssubsequent presentation and interpretationsubsequent 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 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)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 appropriateevents as appropriate

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Relevant StandardsCDISC

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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 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 analysis3. Preparation of Data Management Plan4. Selection of Digitization tool5. Creation of data entry screens6. Creation of edit checks and Data Quality Checks7. Data security implementation

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…activities involved in Data Management

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The ‘How’ of Data ManagementThe 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?�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.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�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�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 3. External data (e.g. electronic laboratory data) are reconciled with

the study database and are complete4. 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 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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