This project involves all 62 institutions that have a Clinical and Translational Science Award (CTSA) and aims to improve the efficiency, safety, and quality of clinical research, focusing on education and training of research personnel engaged in the conduct of clincal trials.
Tom Shanley, M.D
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.
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.
Only UM community is allowed to access this page. Please login to access this site using your Uniqname and Kerberos password.