Protocol Development, Finalization, and Maintenance Standard Practice Guideline

A guide to developing a clinical trial protocol which will stand as the cornerstone of as study, setting out the essential procedures and compliance standards

What is this resource?

The clinical trial protocol outlines the processes, procedures, and guidelines for the execution and oversight of the trial as agreed upon by the site(s), the sponsor, and all relevant regulatory bodies. It is the single most critical document related to clinical trials. Adherence to the protocol is mandated for all who perform research procedures, execute the research criteria, and/or perform measures associated with the trial.

Thoughtful and careful review of the clinical trial protocol during the development stage is paramount. To ensure the protocol is evaluated for safety, feasibility, and scientific merit, a cross-functional team review and approval process should be implemented. Review should take place when the protocol is initially written as well as for any revisions that may subsequently occur. Research staff serving in the following roles should be included in the protocol review and approval process:

• Principal investigator(s) (PI)
• Co-investigator(s) (Co-I)
• Study coordinator
• Study nurse
• Regulatory coordinator
• Statistician
• Project manager (operational)
• Clinical laboratory (including any biorepositories and specialty laboratories)
• Research pharmacy(s)
• External clinical trial site personnel (for multi-site trials)

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.