Clinical Data Management

An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.

1. O

QA Data

“An Introduction

3. CLINICAL TRIAL DATA

5. Key Members

6. Clinical Trials in a Nut Shell

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7. CLINICAL TRIAL OVERVIEW | - ]

Planning «Create Protocol Document = Approve & Sign of |

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Design! ° A -
(Development | Activity + DB Setup + Form Design «Edit Checks «Validation

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Management
7 Review

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Analysis — ||. Statistical Planning» Programming ㆍ Medical Writing

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Filing || Submission Co-ordination QA MI Review M Create Submission } (Regulatory Authority 】

8. Multidisciplinary Teams in Clinical Trials ———

10. CDM Process Overview

11. | CRF design |

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design

Validation/
derivation
rocedures

Activated database
ready to accept
production data

12. __ GRF Design/Review

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17. CRF Annotation

18. Site/Subject Number:

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VISIT 1, DAY 1

Date of Visit:

Time informed consent was obtained: - |
24hr clock

DEMOGRAPHICS

Date of Birth: MAA

19. Validation Checklist:

20. Database set up and testing

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22. Activated

DB

Data entr
Data loading
(CRF and

external da

Safety data
reconci

Resolution
and/or update
of database

Manual
checks/QG

Coding term

23. Data Entry

25. Medical Coding

26. SAE Reconciliation

27. Safety data

Discrepancy
management

Resolution
and/or update
of database

Manual
checks/QC/
2F tracking

Database le
& freeze

oding terms

31. Database
release

Mapping

Statistical
report

tion of Published
tables, figur
and listing.

32. Objectives of CMD

33. Importance of CMD

34. GDM Professionals

35. DM Role in Clinical Research

36. DM Role tn Glinical Research

37. Archiving

38. DATA MANAGEMENT WORKFLOW