Clinical Data Management for beginners

1. Clinical Data Management
Basics
SURABHI JAIN
CLINICAL DATA MANAGER
INDIA

2. Agenda
 In and out about Clinical Data Management (CDM)- Roles and Responsibilities of
Clinical Data Manager
 WHAT
 WHO
 WHY
 HOW

3. What is Clinical Data Management
Bee = 40
Chicken = 0
Putting things in order.

4. What is Clinical Data Management
 Clinical Data Management (CDM) is the process of making the Clinical Data clean,
readable and analyzable.
 CDM is the process which leads to generation of high quality, reliable and
statistically sound data generated from Clinical Trials.
 Collection, integration and validation of the Clinical Trial Data. This helps to
produce a drastic reduction in time from drug development to marketing.

5. WHO!!
Clinical Data Management team can consist of many
arms:
 Clinical Data Managers
 Clinical Database Developer and Programmers
 Clinical Data Associates or Data Entry Associates
Team members of CDM are actively involved in all stages of clinical trial right from
inception to completion.

6. CDMS- Clinical Data Management System
Source data collected at site, must be transcribed into
a SYSTEM so the data can be accessed by CDM team.
CDMS is used to capture paper CRFs or
electronic CRFs data.
pCRF- Data Entry is done by DE Staff after
receiving the pCRF from the site
eCRF- Data Entry is done by the site staff.
(EDC- Electronic Data Capture)
Oracle Clinical
InForm
RAVE
Medrio

7. Phases of Clinical Trial for CDM Activities
 Start Up Phase
 Conduct Phase
 Closure Phase

8. Start-Up Phase
 1st Phase of the Clinical Trial. Version 1.0 of CRF would be finalized.

9. Protocol Review
Preparation of Case
Report Form
Review of Case
Report Form
Database Design and
Cleaning (Edit) Checks
Programming
Medical Coding and External
Data Collection Configuration
User Acceptance Testing
Go-Live Before 1st Patient
1st Visit

10. Conduct Phase
 Phase after Start-Up.
 Data Entry of Clinical Trial Data starts in either paper or electronic CRFs.
 Continues data cleaning by CDM team.

13. Data Cleaning- Why!
Complete Consistent Compliant
DATA- 3Cs

14. Data Cleaning- Types of Discrepancies
Missing Data- Paper and EDC Both
Illegible Data- Only Paper
Out of Range Values- Paper and EDC Both
Protocol Violation- Paper and EDC Both
Logical- Paper and EDC Both

15. Data Cleaning- Ways to Clean Data
 Manually- Manual checks are performed by CDM after data entry is completed.
 Electronic Checks (Edit Checks)- These checks would fire in CDMS as soon as site
saves the data in CDMS.

16. Data Cleaning
 Manual Checks
Complex programming
Human Judgement
Unpredicted Scenarios
Who can conduct Manual Review- CDM, Medical Monitor, CRA, Statistician

17. Data Cleaning
 Automatic Data Validation
Example- As per Protocol- Inclusion Criteria- Male- Female, Age- 18-60
Date of Birth
21-04-1916

18. Data Cleaning-Query Writing
 Good Query leads to expected response, Well most of the time!!
 Good query text must include- What is reported and what is wrong.
 NEVER SUGGEST WHAT TO REPORT……

19. Data Cleaning- SAE Reconciliation
SAE- Serious Adverse Events are reported in CDMS and Safety Database.
Any data which is reported in 2 different places must be reconciled by
consistency.
Field to reconciled- Subject Number, Onset date, outcome, action taken on drug

20. Data Cleaning- External Data
Reconciliation
Data which comes from different vendors not from Investigator site.
Example Central Lab Data, ECG etc.
Common field between CDMS and Vendor data must be reconciled
example Subject Number, Visit, Data of sample collection.

21. Closure Phase- Database Lock
 Database Lock is the final milestone.
 After Last Patient Last Visit.
 All data clean.
 No data will be changed beyond this point.
 Clean Data goes to Biostatistician for analysis.
 CDM can breath easy if no comments from Biostatistician.

22. CDMs- Where they fit in
Study Set Up
• Protocol Review, (e)Case Report Form (CRF) Designing, Edit Check Programming, DM Set Up documents (DMP, CRF Completion
guidelines)
• External Data Identification, Training of the site personnel
Conduct Phase
• Data Cleaning (Query Management), DM Document Maintenance
• Medical Coding, SAE and other external data reconciliation
Database Lock
• Ensure all data clean, QC, Database Lock
• Data Archival and transfer