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.
*If you are interested in the training and cannot attend the February workshop, please sign up to be notified about future workshops at the registration link.
**We aim to provide an outstanding experience for all attendees. If you require reasonable accommodations to attend, please get in touch with the organizers two weeks prior to the event at [email protected].