Dear SOM Clinical Research Community, We are pleased to announce the release of the new Clinical Research Personnel Profile and Training System (PaTS)! The PaTS will serve to collect standardized information about clinical research personnel, offer directed training activities and resources specific to individual responsibilities, and maintain easily accessible records of development activities. For phase … Read more

As clinical research professionals, we focus on maintaining privacy, confidentiality, and data security for our participants. To ensure appropriate handling of Protected Health Information (PHI) and HIPAA compliance when sharing PHI with external parties, be sure to assess whether a business associate agreement (BAA) is required!

Protocol Builder is now available at UNC! Protocol Builder is an online tool designed to help investigators develop clinical protocols with all of the elements needed for efficient scientific and ethical review by the UNC Scientific Review Committee and UNC IRB. Anyone with a UNC ONYEN, including UNC affiliates at other institutions, can log in … Read more

It is with great sadness that I write to let you know that effective June 11, Cassandra (Cassie) Myers will be stepping down as Director of the Office of Human Research Ethics (OHRE) and departing the University to begin a new role with the HR Consulting Group. The Office of the Vice Chancellor for Research … Read more

UNC Clinical Research Community, In the setting of pandemic restrictions beginning to be relaxed by UNC Health, UNC Investigational Drug Services (IDS) plans to begin to allow select onsite monitoring visits. Please refer to the attached memo for additional details. This policy is in effect as of June 29th, 2021 for all monitoring visits not … Read more

Dear SOM Clinical Research Community, In accordance with revised UNC Health policies, SOM personnel reporting to UNCH clinical areas are no longer required to document a daily wellness screening in one of the e-portals. All employees must continue to monitor their own wellness and not report to campus if feeling unwell or experiencing any symptoms … Read more

Important Update: On April 28th, the FDA issued a notice of non-compliance to an industry sponsor for failure to submit required results information to ClinicalTrials.gov. If the required information is not submitted within 30 days, the FDA may seek civil monetary penalties consisting of an initial $12,316 fine followed by daily $12,316 fines thereafter until … Read more

WE ARE 7 WEEKS INTO THE NEW BCA AND CHARGE REVIEW PROCESSES AND WOULD LIKE TO PROVIDE THE FOLLOWING REMINDERS: When creating a new CRMS record, setting the study status to “New” triggers the central coverage analysis process. If you do not yet have a protocol, you should wait until you do, then enter the … Read more

Dear SOM Clinical Research Community, Several upcoming changes to UNC guidelines and processes have been announced in the past weeks. To support ongoing understanding of and compliance with the current guidelines, the SOM CRSO has retired the previous “UNC SOM GUIDELINES FOR HUMAN SUBJECTS RESEARCH IN THE CONTEXT OF COVID-19” document and replaced it with … Read more

To:  Research Community,As we prepare for the June 1, 2021’s new research guidelines and moving towards normal operations with ongoing recommendations from the Office of the Vice Chancellor for Research, the OHRE is removing the requirement for the COVID Information Sheet.  Please note we have attached an IRB letter, approving the discontinuation to utilize for … Read more