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 3: ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management
This session will cover new requirements for registration, updates, use of special informed consent language, results reporting, and protocol uploads. Group exercises and discussion will help participants learn how to avoid common mistakes in ClinicalTrials.gov. Topics will include how to draft arms and interventions, translating protocol aims into specific outcome measures, and results reporting for different clinical trial models.
Please plan to bring a laptop or tablet for hands on work. Contact Nicole Exe at firstname.lastname@example.org if you do not have a device to bring.
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.
Other topics include:
- Session 1: Monitoring for Clinical Trials (May 10)
- Session 2: Procedures Documentation for Clinical Trials (May 17)
Registration is required - register here.