Who is reading your trial documents, and what does that impact?
Session 2 | 12:00 PM to 1:00 PM
Join the Clinical Trials Support Office for our upcoming June Lunch & Learn. For this two-part series, understand how to convert a grant proposal into essential research documents (e.g., study protocol, manual of operations, consent document, and data forms) under the regulatory and administrative requirements of ClinicalTrials.gov, IRB, Study Sponsor, Data Sharing Repository, and more.
During this applied and interactive session, participants will use examples from their own research portfolio to:
- Review essential study document mapping from Session 1
- Learn how to use the NIH protocol template and other resources to transform a proposal into a study protocol
- Apply ClinicalTrials.gov, IRB, and Sponsor guidelines to begin generating other study documents such as data forms and/or manual of operations
Click here to view Session 1.
- Angie Lyden, MS, Clinical Research Science Coordinator, CTSO
- Diane Wilson, MPP, JD, MA, Regulatory Manager, Office of Regulatory Affairs
- Susan Murphy, ScD, OTR/L, Associate Professor, Department of Physical Medicine and Rehabilitation; Medical Director, Behavior, Function, & Pain CTSU
Both sessions will be held virtually. View the join information below.
Join Zoom Meeting: https://umich-health.zoom.us/j/91134891011