Essential Documents in Clinical Research

This course focuses on the essential documents that demonstrate regulatory compliance, data quality, and subject protection in clinical trials. Learners review Trial Master File (TMF) structure, Investigator’s Brochure content, protocol components, informed consent processes, and Case Report Form (CRF) development and use.

Course Benefits & Career Prospects

• Identify and organize essential documents required across the clinical trial lifecycle.
• Understand TMF structure, version control, and inspection expectations.
• Contribute to protocol, Investigator’s Brochure, and informed consent development or review.
• Recognize the importance of CRF design in data collection and analysis.
• Job placement assistance: documentation support roles (CTA, TMF Associate, Study Admin).

Modules

• Essential Documents, Record Keeping & Trial Master File (TMF)
• Investigator’s Brochure – Development, Use & Importance
• Protocol Development & Review Process
• Informed Consent Document (Development, Use & Importance) & Informed Consent Procedure
• Case Report Forms (Design & Use)