Procedures Documentation for Clinical Trials

An interactive, virtual session to introduce participants to best practices for procedures documentation to ensure standardized practices across personnel and sites of a clinical trial

What is this offering?

This interactive, virtual session will introduce participants to best practices for procedures documentation to ensure standardized practices across personnel and sites of a clinical trial. While we will touch on several methods for documentation, the workshop will mainly focus on creating, interpreting and using a manual of procedures (MOP). Topics include an overview of the sections in a MOP, what to do if a documented procedure isn’t feasible, and how to use a MOP to address issues that may occur during a clinical trial. Participants will engage in activities in small groups.

Primary audience: Study team members who are involved with day-to-day procedures for any type of clinical trial including social/behavioral, drug, device, and biologics. This includes anyone who needs to follow procedures created by others and those who are participating in creating documentation for others. This is intermediate-level training, so participants are expected to understand basic clinical trials procedures and terminology through experience or prior training. While U-M employees or students from any campus or affiliate will be given higher priority for registration, anyone currently working on a clinical trial is welcome.

How this advances translational science

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