Effective November 1, 2014, submissions that remain in “draft” status (i.e., never submitted to the IRB) for more than six months will be automatically deleted on a monthly schedule.  To prevent deletion, simply access the submission and click the Save button … Read more

We continue to experience delays in processing time.  Recent changes in our computer system (IRBIS) have impacted the time it takes to review and approve submissions.  We appreciate your patience while we get through this transition.  Click here for guidance … Read more

Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available. A UPIRSO (Unanticipated Problem Involving Risks to … Read more

The CITI Good Clinical Practice (GCP) training module is now required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects and a drug, device or biologic is included in the … Read more

A new version of the IRB SOPs (dated 4/24/2014) is posted here and includes the following changes: SOP 3.2-Revised to reflect current practices regarding inter-institutional agreements (specifically, reliance on central IRBs). SOP 19-Unanticipated Problems Involving Risks to Subjects or Others … Read more