Skip Main Navigation
Page Content

Save This Event

Event Saved

Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov. (IMPACT): November 2019

MICHR Education

Tuesday, November 5, 2019 at 2:00 PM - Tuesday, November 19, 2019 at 4:00 PM (EST)

Registration Information

Type Remaining End Quantity
Procedures Documentation for Clinical Trials - Nov 5, 2019 2 Registrations Ended Free  
Monitoring for Clinical Trials - Nov 12, 2019 8 Registrations Ended Free  
Are You Ready?: How ClinicalTrials.gov requirements are shaping study design and implementation - Nov 19, 2019 1 Registration Ended Free  
Procedures Documentation for Clinical Trials Waitlist 20 Registrations Ended Free  
Monitoring for Clinical Trials Waitlist 19 Registrations Ended Free  
ClinicalTrials.gov Waitlist 20 Registrations 3d 4h 27m Free  

Share Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov. (IMPACT): November 2019

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 Room #3515.

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 5, 2019)
  • Monitoring for Clinical Trials (November 12, 2019)
  • Are you Ready?: How ClinicalTrials.gov requirements are shaping study design and implementation (November 19, 2019)

REGISTRATION IS REQUIRED 

Session Descriptions:

Procedures Documentation for Clinical Trials

November 5, 2019 - 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 12, 2019 - 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.

Are you Ready?: How ClinicalTrials.gov requirements are shaping study design and implementation 

November 19, 2019 - 2:00 - 4:00 pm

New requirements for registration, updates, use of special informed consent language, results reporting, data sharing, and protocol uploads are changing the way studies are designed and implemented. Group exercises and discussion with regulatory and data sharing specialists will help participants learn how to avoid common mistakes in ClinicalTrials.gov and what issues must be addressed in protocols, data sharing plans, and informed consents to facilitate successful registration and, when necessary, results reporting. 

This session will especially benefit study team members involved with or likely to become involved with Investigator-Initiated Studies that have not started enrolling but anyone with a basic knowledge of clinical trials is welcome.

1)    Is this a Clinical Trial?  Is it only one trial?

2)    What do acceptable data sharing plans look like?

3)    What are primary and secondary outcome measures?

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.

To get the most out of this session, it is recommended that participants have some familiarity with ClinicalTrials.gov or previously attended ClinicalTrials.gov registration training from the Office of Regulatory Affairs but it is not required.

 **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!

Have questions about Instruction in Monitoring, Procedures Documentation and ClinicalTrials.gov. (IMPACT): November 2019? Contact MICHR Education

Save This Event

Event Saved

When & Where


Biomedical Science Research Building (BSRB)
Room #3515
109 Zina Pitcher Place
Ann Arbor, MI 48109

Tuesday, November 5, 2019 at 2:00 PM - Tuesday, November 19, 2019 at 4:00 PM (EST)


  Add to my calendar

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 multidsciplinary education, career development, and mentoring programs aimed at increasing the number of high-quality clinical and translational researchers across a broad career continuum.

**Our aim is to provide an outstanding experience for all attendees. If you require reasonable accommodations in order to attend, please contact the organizers at least 2 weeks prior to the event.

  Contact the Organizer

Interested in hosting your own event?

Join millions of people on Eventbrite.

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.