Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities

This course provides a comprehensive introduction to clinical trial planning including data management, clinical trial database design, case report forms (CRFs), as well as protocol development and informed consent requirements.

The curriculum examines clinical trial agreements, contract and budget negotiation, investigator and site selection, and the full operational workflow of pre-study visits and global study start-up activities, including regulatory harmonization.

Learners will gain practical experience with Institutional Review Board (IRB) submissions, electronic records and signature regulations, and best practices for maintaining compliance throughout the trial lifecycle.