New requirements for registration, updates, results reporting, data sharing, and protocol and informed consent uploads are changing the way studies are designed and implemented. Group exercises and discussion with regulatory and data sharing specialists will help participants learn how to avoid common mistakes in ClinicalTrials.gov and what issues must be addressed in protocols, data sharing plans, and informed consents to facilitate successful registration and, when necessary, results reporting. To get the most out of this session, it is recommended that participants have some familiarity with ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training from the Office of Regulatory Affairs but it is not required.
 

Primary audience: Investigators, senior study team members, or anyone else involved in study design, grant writing, protocol development or any other aspect of planning Investigator-Initiated Studies that have not started enrolling. But anyone with a basic knowledge of clinical trials is welcome. Due to confidentiality and U-M specific policies and procedures this session is only open to U-M employees, employees of officially affiliated health systems such as Metro Health or Mid-Michigan, or persons who are directly working on a clinical trial with a U-M principal investigator.

When: Thursday, June 10
Time: 2-4 p.m.
Where: This session will be held online, and the organizers will be in touch with more information after you register.

Register here for this workshop.