Advanced Certified Program in Clinical Research & Clinical Data Management

Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials.  Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course comprises theory and practical sessions, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications. 

This course will provide extensive practical training in the niche domain of clinical data management with hands on experience on Oracle Inform.  It incorporates end-to-end theoretical & practical training sessions on Clinical Data Management applications widely used by Pharma & IT Industry.

Following Course Content will be covered during the training:

• Welcome and Introduction to Clinical Data Management
• Drug Development and Clinical Trial Phases 
• Fundamentals of Clinical Research & Roles in a CRO 
• Clinical Data Management Process & Life cycle
• ICH – GCP guidelines
• GCDMP guidelines 
• Paper Vs Electronic Data capture 
• Data Management Plan document
• Introduction to CDISC SDTM  Standards 
• Application of SDTM Standards.
• Clinical Study Documentations Setup
• CRF Annotation
• Creation of SDTM annotated CRF 
• Creation of Database Structure Document 
• Creation of Edit Check Specification Documents 
• Study User Acceptance Test (UAT) documents
• Project Initiation
• CRF Design/ eCRF design 
• 21 CFR Part 11 Regulations
• Questions and Discussions