July 15, 2014
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 study. Deadline for completion is October 1, 2014. A refresher course will be required every two years.
The GCP training requirement is in addition to the OHRE requirement for Human Research Ethics Training (CITI Human Subjects Research Protection modules).
If you have further questions regarding the required GCP training, please contact the Office of Clinical Trials at email@example.com or call 919-843-2698.
June 12, 2014
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 (UPIRSO) reporting revised to require reporting of events that meet all three criteria (previously events that meet criteria 1 & 2 (related and unexpected) were reportable to the IRB)
- SOP 22-Revised to clarify that all events meeting the criteria for an UPIRSOs or cases of alleged serious or continuing non-compliance, will be reviewed by the convened IRB for a final determination.
- SOP 29-Revised HIPAA section to add information regarding “compound authorizations”
- SOP 37- New SOP: Sponsor-initiated holds, suspension and termination of IRB approval (Sections of SOPs 14.3 and 18.1 deleted to eliminate duplication.)
- Revised appendices: F, I, J, K, Q, R, U and Y
May 8, 2014
Two changes to the routing of IRB correspondence, effective immediately:
1) Co-Investigators will now be copied on all IRB-related correspondence automatically, in addition to Principal Investigators and Faculty Advisors. Other members of the research team (e.g., Study Coordinators, Regulatory Associates) can still be added to the copy list, optionally, as currently done.
2) Department heads will be copied on determinations that a project is "Not Human Subjects Research" (NHSR). While these activities do not require IRB approval, they may still raise concerns and/or warrant departmental oversight.
March 31, 2014
Tuesday, April 8 only, our phone lines will be down, sporadically. When you attempt to call our office or individual staff members, you may hear a busy signal or a message stating that the phone number is not in service. If so, you will be unable to leave a voice message. Please try again, later. Thanks for bearing with us while our phone system is upgraded.
January 28, 2014
Recent changes in our computer system (IRBIS) have led to a delay in processing time. This is impacting the time it takes to review and approve submissions. We appreciate your patience while we get through this transition.