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

MICHR Education

Thursday, May 10, 2018 at 2:30 PM - Thursday, May 31, 2018 at 4:30 PM (EDT)

Registration Information

Type Remaining End Quantity
Monitoring for Clinical Trials - May 10th 16 Registrations May 10, 2018 Free  
Procedures Documentation for Clinical Trials - May 17th 14 Registrations May 17, 2018 Free  
ClinicalTrials.gov and It's Interaction with Protocols, Documents and Study Management - May 31st 15 Registrations May 31, 2018 Free  
Monitoring for Clinical Trials Waitlist 20 Registrations May 10, 2018 Free  
Procedures Documentation for Clinical Trials Waitlist 20 Registrations May 17, 2018 Free  
ClinicalTrials.gov Waitlist 20 Registrations May 31, 2018 Free  

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Event Details

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 BSRB in the Seminar rooms on the main floor.

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

Topics include: 

  • Monitoring for Clinical Trials (May 10, 2018)
  • Procedures Documentation for Clinical Trials (May 17, 2018)
  • ClinicalTrials.gov and Its Interaction with Protocols, Documents and Study Management (May 31, 2018)

 

REGISTRATION IS REQUIRED 

Session Descriptions:

 

Monitoring for Clinical Trials

May 10, 2018 - 2:30 - 4:30 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.

 

Procedures Documentation for Clinical Trials

May 17, 2018 - 2:30 - 4:30 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. 

 

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

May 31, 2018 - 2:30 - 4:30 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.

Please plan to bring a laptop or tablet for hands on work. Contact Nicole Exe at nexe@med.umich.edu 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. 

Have questions about Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov (IMPACT): May 2018? Contact MICHR Education

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When & Where


Biomedical Science Research Building (BSRB) Seminar Rooms ABC
109 Zina Pitcher Place
Ann Arbor, MI 48109

Thursday, May 10, 2018 at 2:30 PM - Thursday, May 31, 2018 at 4:30 PM (EDT)


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Organizer

MICHR Education

Clinical and translational training has never been more exciting or accessible than it is today at the University of Michigan. The mission of MICHR's Education & Training programs is to provide engaging and effective multidisciplinary educationcareer development, and mentoring programs aimed at increasing the number of high-quality clinical and translational researchers across a broad career continuum. 

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