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Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT) Workshop: Session 2 - Procedures Documentation for Clinical Trials

  • BSRB Seminar Rooms A ,B and C (map)

Have you completed basic instruction in clinical research but are looking for more? The Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT) workshop series is designed for study team members who are ready for an intermediate level of training for clinical trials skills. Participants will learn critical clinical research skills through a group learning environment and hands-on skills practice. Maximum benefit will be gained by attending all three sessions, but it is not required. All sessions are held at BSRB Seminar Rooms A ,B and C.

Brought to you by the Michigan Institute for Clinical & Health Research (MICHR) and the Clinical Trial Support Office (CTSO).

Session 2: Procedures Documentation for Clinical Trials
This session will introduce participants to best practices for creating, interpreting and using a manual of procedures (MOP) and other procedures documentation to ensure standardized practices across personnel and sites of a clinical trial. Topics will include an overview of sections to include in a MOP, what to do if a documented procedure isn’t feasible and information about the new IRB requirement for uploading a MOP if you are coordinating a multi-site trial. 

Other topics include: 

  • Session 1: Monitoring for Clinical Trials (May 10)
  • Session 3: ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management (May 31)

Registration is required - register here.