Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT): November 2018

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 University Hospital, 2nd Floor Room #2C108.

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 (Nov 7, 2018)
• Monitoring for Clinical Trials (Nov 13, 2018)
• ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management (Nov 28, 2018)

REGISTRATION IS REQUIRED

Session Descriptions:

Procedures Documentation for Clinical Trials

November 7, 2018 - 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, 2018 - 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 28, 2018 - 2:00 - 4:00 pm

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.

This session is only open to U-M employees or persons who are directly working on a clinical trial with a U-M principal investigator.

Please plan to bring a laptop or tablet for hands on work. Contact Nicole Exe at nexe@med.umich.edu at least 2 weeks prior to the event if you do not have a device to bring.

To get the most out of this session, it is recomended that participants have some familiarity with ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training from the Office of Regulatory Affairs.

**Our aim is to provide an outstanding experience for all attendees. If you require reasonable accommodations in order to attend, please contact the organizers two weeks prior to the event. Thank you!