Clinical Data Management (CDM) is a crucial process in Clinical Research and is accountable for generating high-quality, reliable, and statistically sound data from pharmaceutical and clinical trials. This course provides a detailed overview of concepts and practical methods implied in planning, collecting, storing, and distributing data in clinical research. In addition, the course also describes how global clinical data strategy is prepared including the standardization of case record form (CRF), CRF compiling guidelines, data lifecycle plans, validation specifications, and therapeutic/phase specific information.
Upon the completion of this course, participants would be able to:
● Use Clinical Data Management System (CDMS) to manage data in clinical trials and research.
● Understand essential elements of clinical data management, theoretical knowledge on regulatory guidelines, CDM workflow, and data management plans.
● Understand CDMS activities involving CRF designing, data entry, data collection, AE management, report creation.
● Understand the responsibilities of CDM personnel.
Who Should Attend
Candidates who want to build their career as a CDM professional, Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres, candidates who want to work on full time/ part-time on flexible hours.