Clinical Trials Support Office offering two-part educational opportunity for faculty and staff covering essential trial documents

May 26, 2020  //  FOUND IN: Updates & Resources

Join the Clinical Trials Support Office for its 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.

Session 1 | Friday, June 5 – Noon to 1 p.m. | Register HERE

At the end of this session, participants will be able to:

  • Describe the impact of ClinicalTrials.gov requirements and how that impacts the study protocol, what data needs to be collected and in what format
  • Identify the key study documents required before activating a study and their respective purposes and audiences

Session 2 | Friday, June 19 – Noon to 1 p.m. | Register HERE

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

Presented by:

  • Angie Lyden, M.S., clinical research science coordinator, CTSO
  • Diane Wilson, M.P.P., J.D., M.A., regulatory manager, Office of Regulatory Affairs
  • Susan Murphy, Sc.D., OTR/L, associate professor, Department of Physical Medicine and Rehabilitation; medical director, Behavior, Function, & Pain CTSU

Both sessions will be held virtually through Zoom.

Join Zoom Meeting

https://umich-health.zoom.us/j/91134891011

Website: https://umichumhs.qualtrics.com/jfe/form/SV_5Auc0r8SGwYnYLb

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