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Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov...

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Danto Auditorium, Cardiovascular Center

1500 E. Medical Center Dr

Ann Arbor, MI 48109

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Program Overview:

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 Danto Auditorium.

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

Topics include:

  • Procedures Documentation for Clinical Trials (November 6, 2017)
  • Monitoring for Clinical Trials (November 13, 2017)
  • ClinicalTrials.gov and It's Interaction with Protocols, Documents and Study Management (November 20, 2017)

REGISTRATION IS REQUIRED

Session Descriptions:

Procedures Documentation for Clinical Trials

November 6, 2017 - 2:00 - 4:00 pm

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.

Monitoring for Clinical Trials

November 13, 2017 - 2:00 - 4:00 pm

This session will introduce participants to best practices in preparing for and participating in clinical trial monitoring visits. Topics will include understanding the purpose of monitoring and how it differs from an audit, what to expect from different types of monitoring visits, and tips on responding to follow-up letters and reports.

ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management

November 20, 2017 - 2:00 - 4:00 pm

Before attending this session participants should have either used ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training from the Office of Regulatory Affairs. 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.

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Danto Auditorium, Cardiovascular Center

1500 E. Medical Center Dr

Ann Arbor, MI 48109

View Map

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