Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are needed before and during the trial, and the trial does not end until a final report has been submitted. Documentation of the trial often continues with articles in the biomedical literature. This course provides insight into the processes for preparing effective study protocols, reports, and summaries. Participants have opportunities to practice preparing documents and applying the rules governing clinical trial documentation.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe the importance of the Clinical trial documentation, regulatory submission requirements
• Explain how clinical trial documentation fits in the common technical document (CTD) organization of marketing submissions
• Identify documents that are essential for the conduct of a clinical trial
• Describe the main steps in document preparation process
• Identify key elements of a study protocol
• Recognize and describe required elements of informed consent
• Explain the importance of version control
• Explain the reasons behind the importance of a well written informed consent form, SAE narrative, or monitoring trip report
• Write sections of a brief Clinical Study Protocol and Report Synopsis

Topics Include

• Regulatory requirements – CTD and eCTD – IND, NDA, BLA
• Protocol development
• Informed Consent (ICF), Health Insurance Portability and Accountability Act
• Detailed Clinical Study Reports (ICH E3)

Professional Credit

UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours