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Important Update: Clinical Research Monitor Vaccine Requirements (NRP Listserv)

December 19, 2022

IMPORTANT UPDATE Due to REDCap’s recent URL change (…”rc1…”), the Attestation Survey pathways have also changed. Please utilize the following links to each of the surveys going forward: Confidentiality Attestation Immunization Attestation As a reminder, you can access the associated policy here: COVID-19 Immunization of Healthcare Personnel

Resource Hub: Bloom Process Mapping Tool

December 14, 2022

Completing all the steps to initiate an industry-sponsored trial can be daunting. Requirements vary depending on study characteristics and knowing what steps to complete in what order can be confusing and lead to misdirected effort. To assist study teams in navigating this process, we have developed an innovative graph database tool that accounts for dependencies between steps to create customized and comprehensive study initiation process maps.

Tax Reporting Obligations for Research Participants (NRP Listserv)

December 13, 2022

          Update on Tax Reporting Obligations for Research Participants   Pursuant to U.S. tax laws, the University is required to issue an IRS Form 1099 to U.S. persons who receive $600 or more from the University during a calendar year. This applies to payments in the aggregate. Accounts Payable is the unit on campus that … Continued

IDS Winter Holiday Closures (NRP Listserv)

December 12, 2022

Good morning, IDS will be closed on Monday, Dec 26th and Monday, Jan 2nd in observance of the winter holidays. We will be open for regular operations Tuesday, Dec 27th thru Friday, Dec 30th. Thank you and Happy Holidays!    

NRP 2023 Professional Development Award- Now Accepting Applications (NRP Listserv)

November 18, 2022

Dear UNC Research Community, The UNC Network for Research Professionals is proud to announce the 2023 NRP Professional Development Award. This award provides supplemental funding to help cover professional development opportunities for University of North Carolina at Chapel Hill employees whose work is focused on Human Subjects Research. The award covers work-related education and training; … Continued

Epic@UNC Bi-Annual Research Release Highlights (NRP Listserv)

November 10, 2022

Good morning Research Community, Our next bi-annual Epic@UNC release is scheduled for this Sunday morning, Nov. 13, across UNC Health to ensure the latest features are available to our teams. Review the info on this page to see the updates now available for each Epic@UNC application. Note that: To ensure a smooth bi-annual release on Sunday, Nov. 13, ISD must … Continued

Clinical Research Space

November 7, 2022

Dear Research Colleagues, In early 2021, The Institute for Global Health and Infectious Disease Clinical Trials Unit opened an off campus research unit to facilitate COVID-19 treatment and vaccination trials. The ‘Global Clinical Research – North’ is located at 1828 MLK Jr. Blvd. in the Chapel Hill North shopping center just around the corner from … Continued

Insightalyst: FDA Issues Draft Guidance on Protecting Children Who Participate in Clinical Trials

October 11, 2022

On September 26, 2022, the U.S. Food and Drug Administration (FDA) announced in the Federal Registry the newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The goal of this guidance is to provide FDA’s perspective on the ethical considerations for including children in clinical trials.

Insightalyst: FDA Announces Proposed Rules to harmonize with the revised Common Rule

October 7, 2022

As part of its obligations under the 21st Century Cures Act, the U.S. Food and Drug Administration (FDA) announced, on September 28, 2022, two proposed rules aimed at harmonizing, to the “extent practicable and consistent with statutory provisions,” certain sections of the agency’s regulations on human subject protections and Institutional Review Boards (IRBs) with the “Federal Policy for the Protection of Human Subjects” (revised Common Rule).