Clinical Research Managment Chronicles: Documenting Study Staff Protocol Training

Whether you are submitting an application for the first time or making changes to an existing application, always remember to review closely Section 44.2 of your eResearch submission. This is important because anything that is listed in Section 44.2 will automatically appear on the IRB approval letter. Often, previously submitted documents may no longer apply when a new amendment is generated and you may need to remove or add language based on the new information you are submitting. Fortunately, the eResearch system will notify you to update this section before submitting, so please take time to review and make any necessary changes.

Sign-up for the Next ClinicalTrials.gov Workshops

Maintained by the National Library of Medicine at the National Institutes of Health, Clinicaltrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies. Does your study need to be registered in ClinicalTrials.gov? Do you want to know how to report your results on the ClinicalTrials.gov website? If so, the Office of Regulatory Affairs at the University of Michigan hosts several workshops to help you navigate ClinicalTrials.gov.

Regulatory Binder

Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced are considered Essential Documents. They serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements.

Standard Operating Procedure (SOPs) Reference Guide

 Visit MICHR's Clinical Research Management Group Here

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