CLINICAL DATA MANAGEMENT OVERVIEW & WORKFLOW

CLINICAL DATA MANAGEMENT -AN OVERVIEW Rajashekar BachaliIMPORTANCE OF DM IN CR

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.

CLINICAL DATA-MANAGEMENT

Most valuable asset to a pharmaceutical company Serves as a basis for submission, approval and marketing of a compound.

Data Management PlanCase Report Form designing CRF annotation Database designing Data-entryData validationDiscrepancy management Medical coding Data extraction Database locking

What does aClinical Data Managerdo???

Make sure that the right information is collected during a clinical trial and that data is accurate.This achieved through careful design of the data collection tools.

TOOLS FOR CDM (CDMS)In regulatory submission studies, maintaining an audit trail of data management activities is of paramount importance. These CDM tools ensure the audit trail and help in the management of discrepancies.Many software tools are available for data management.Most of the CDMS used in pharmaceutical companies are ORACLE CLINICAL,INFORM, CLINTRIAL, MACRO, RAVE, and eClinical Suite.

Regulations,Guidelines, and Standards in CDM

CDM has certain guidelines and standards that must be follow , Since the pharmaceutical industry relies on the electronically captured data for the evaluation of medicines, there is a need to follow good practices and maintain standards in CDM .

21 CFR Part 11GCDMPCDISC

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