Who is reading your trial documents, and what does that impact? | Session 1

FOUND IN: Events, Research Event

Date

Friday, June 5, 2020

Time

12:00pm - 1:00pm

Location

Virtual Event

Description

Who is reading your trial documents, and what does that impact?
Session 1 | 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.​

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

Presented by:

  • 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

REGISTER HERE.

Both sessions will be held virtually. View the join information below.

Join Zoom Meeting: https://umich-health.zoom.us/j/91134891011

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