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Please see below for announcements that have been disseminated via the CRSO and NRP listservs. The most recent announcements appear first.

  • FDA Issues Draft Guidance on Protecting Children Who Participate in Clinical Trials

    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September 26, 2022, the U.S. Food and Drug Administration (FDA) announced in the Federal Registry the newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”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.

  • FDA Announces Proposed Rules to harmonize with the revised Common Rule

    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).

  • Resource Hub: Fillable Informed Consent Self-Assessment Form

    To take the paper out of your paperwork, we are excited to release an electronically fillable PDF version of the Informed Consent Self-Assessment.

  • Formal Call to the ONE UNC Clinical Research Design Journey

    Dear SOM Clinical Research Community, The ONE UNC Clinical Research Initiative is accepting applications for design committee members. The invitation to join a design group is open to anyone in the UNC and UNC Health research communities. If you are interested in being part of this collaborative initiative, please sign up here: Thank you!   … Continued

  • In the Know: Creating Research Registries

    Navigating the regulations and requirements related to clinical data and research data can be confusing. Registries (i.e. databases, repositories) can be valuable tools for understanding both clinical and research data. Unlike a clinical registry, research registries or repositories involving data and/or specimens require IRB oversight.

  • Resource Hub: Flexible Work Options Playbook

    As remote and hybrid working is becoming the “new norm” for many SOM clinical research teams, it is important to find team-oriented solutions that encourage employee productivity and growth.

  • Important Change to Billing Coverage Analysis (BCA) Requests (NRP Listserv)

    Dear UNC Research Community, Effective September 12, 2022, the process for requesting a Billing Coverage Analysis (BCA) will change.  We are now utilizing the Service Now ticketing system for all BCA requests. This system will make it easier for the Research community by providing one central location to submit a BCA request. The below link … Continued

  • Use of Non-UNC Email for Research

    Dear SOM Clinical Research Community, Please be sure to review the announcement below regarding the requirement to utilize only UNC email addresses for communicating with research participants via email. -SOM CRSO   [FORMAL NOTICE] Use of non-UNC Email for Research   Use of non-UNC Email Accounts for Research Recruitment Recruitment of subjects for research is … Continued

  • Town Hall: One UNC Clinical Research

    The Research Integration Team invites you to join an interactive conversation about the One UNC Clinical Research Initiative between the Office of the Vice Chancellor for Research, School of Medicine, and Healthcare System. All are encouraged to participate, share thoughts, and ask questions.   Wednesday, September 14, 2:00-3:00 PM Click here to register Click here … Continued

  • Resource Hub: as Texting Platform

    As clinical research methods and standards strive to keep pace with the needs of our research participants, it is important to consider communication preferences. Text messaging with participants is an often desired method of communication and can bolster participant understanding and compliance with study activities. UNC-CH has completed a security review and executed a Business Associate Agreement (BAA) with to permit this service to be utilized for communication with research participants.

  • In the Know: Clinical Trial Requirement to Post Informed Consent Form

    Most research teams are aware of the requirements to list clinical trials and upload results to, but did you know you are also required to post the consent form? The 2018 Requirements state that a consent form must be posted to a designated federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.

  • Resource Hub: Informed Consent Self Assessment Tool

    Self-assessment is a valuable activity that can be informative in a variety of settings, including informed consent for clinical research. Now you can proactively discover your informed consent process strengths and areas for improvement using a new Informed Consent Self-Assessment tool!

  • Did You Know? Investigator Brochure Updates (UNC OHRE)

    How do I submit my Investigator’s Brochure (IB) update to the IRB? Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are reviewed annually and may be updated with Investigational Product (IP) information which does … Continued

  • Resource Hub: New Clinical Research Glossary

    Whether you are new to clinical research or an experienced member of the research team, mastering the highly specialized vocabulary (and alphabet soup!) of clinical research and using it effectively in professional communications can be challenging. To bolster understanding and facilitate effective communication in the SOM and beyond, we have created a concise and organized glossary of clinical research terms that aligns with industry and regulatory standards.

  • Important – IV Contrast Update (NRP Listserv)

    Update regarding the shortage of contrast media from Lauren M.B. Burke, MD, FSAR, executive Vice Chair of Radiology In the last few weeks, GE has increased production of Omnipaque 300 and 350, the most common contrast media concentrations used in Imaging Services, with production currently at or above 75% of typical production.  UNC has been … Continued

  • Pre-Paid Card Updates (NRP Listserv)

      THE UNIVERSITY of NORTH CAROLINA at CHAPEL HILL Office of Sponsored Research – Communication   Pre-Paid Card Updates New Resources, Updated Forms, and Year-End Deadlines Release Date: June 9, 2022 The Office of Sponsored Research (OSR) in conjunction with the Finance Cash Management Team has created new resources and updated forms for PrePaid Cards. Guidance … Continued

  • Resource Hub: UNC Research Contacts Webpage

    The CRSO recently published the UNC Research Contacts webpage on our website. This webpage includes contact information for various UNC-CH research offices and services.

  • UPDATE: Process Change for Research Monitor Visit Request for Epic Access

    Updated message from the UNCH Health Information Management and Epic Research teams: Good morning Research Community! After a little hiccup yesterday, we’re happy to announce that the MySupport Research Monitor Visit Request process is officially LIVE. We’ve updated one element of the tip sheet, Please delete the tip sheet sent on 5/27/22. Additionally, we’ve updated … Continued

  • PaTS and SOP FAQs

    Dear SOM Clinical Research Community, Thank you for your engagement, feedback and questions related to the new personnel Profile and Training System (PaTS) and SOM-wide Standard Operating Procedures (SOPs)! Please review the FAQs listed below. We will continue to add additional information to the CRSO website as we work to make new tools and processes … Continued

  • Process Change for Research Monitor Visit Request for Epic Access

    A Message from the UNCH Health Information Management and Epic Research teams: Greetings Research Community, We are excited to bring to you, much needed process enhancements with how you request Epic access for research monitoring visits. In anticipation of HIM operations processing ALL monitoring request for Epic access, UNCH HIM and Epic@UNC Research teams collaborated … Continued

  • Reminder: Complete Your Informed Consent SOP Attestation

    Dear SOM Clinical Research Community, If you are involved in obtaining informed consent from adult research participants, please be sure to login to PaTS to review the SOM SOP 401.1 and complete your attestation no later than 6/14/2022. The CRSO will host two informational sessions to provide a general overview of the SOP, answer questions, … Continued

  • 2022 Clinical Research Staff Satisfaction Survey

    Dear SOM Clinical Research Community, In early March we distributed a survey to assess job satisfaction among clinical research staff. We received 116 responses; 76% from staff with 5 or more years of clinical research experience. Overall, 66% of respondents indicated that they are either somewhat satisfied or very satisfied in their jobs. The most … Continued

  • Reminder: Invitation to Provide SOP Review and Feedback

    Dear SOM Clinical Research Community, If you have not yet reviewed the proposed SOP on Performing the Responsibilities of the Principal Investigator, please take a few minutes to review and provide any feedback you may have. To review the SOP and submit feedback, please follow this link to the online survey. The survey will be available … Continued

  • Happy Researcher Appreciation Week: Ways to Celebrate!- UNC NRP

    Today marks the start of UNC’s Researcher Appreciation Week and we are so thankful for each and every one of you! We’re not the only ones – check out this video message from leadership recognizing your contributions and the incredible work you do every day. It’s remarkable and inspiring to witness the daily dedication and … Continued

  • New SOM SOP Issued

    Dear SOM Clinical Research Community, The CRSO is excited to announce that SOM SOP 401.1, Obtaining and Documenting Informed Consent from Adult Research Participants, has been issued. The SOP will take effect on 6/15/2022 and applies to all SOM human subjects research. If you have created your PaTS profile and indicated that you are responsible … Continued

  • Important Notification: Change to COVID Screening Requirements for Participants

    Dear SOM Clinical Research Community, To maintain alignment with operations and policies of UNC Health, the SOM will no longer require study personnel to conduct and document COVID screening for research participants. Alternatively, the study team shall ask participants to conduct a self-screening assessment prior to any in-person visit. If a participant screens positive, they … Continued

  • Resource Hub: Participant Recruitment Resource Center

    Effectively recruiting and enrolling study participants is often the most challenging aspect of executing a clinical research protocol. Set your study up for success by planning comprehensive recruitment strategies!

  • Meet your Epic@UNC Research Team- UNC NRP

    Hi Research Community! It’s a been a minute since we have all gotten together. I wanted to make sure you knew we are here to help support you and who we are. The best ways to contact the Epic@UNC Research Team Have a question or need something new in Epic: Submit a Service Request Something … Continued

  • Unblinded Billing Contact- UNC NRP

    Good afternoon all, I wanted to share an update to CRMS when requesting IDS services. Earlier this year, IDS was investigating potential ways to help avoid accidental unblinding of studies due to billing. In February of this year, CRMS updated their communication for billing contact to now state “unblinded billing contact”. Please do not hesitate … Continued

  • Invitation to Provide SOP Review and Feedback

    The SOM CRSO is in the process of developing a portfolio of Standard Operating Procedures (SOPs) widely applicable to clinical research conducted across the SOM to achieve efficient and consistent workflows, ensure regulatory compliance, and realize best operational practices in clinical research. As an individual who may be responsible for conducting processes covered by the … Continued

  • SOM PaTS System Update : Profile Enhancements

    Dear PaTS Users, On April 28th we deployed a number of fixes and enhancements to PaTS to address a variety of feedback and issues that have been submitted by our users, especially regarding clarity of when your profile has been successfully saved. The reports users submitted around their user profile, overall user experience, and bug … Continued

  • New SOM CRSO Regulatory Blog

    Dear SOM Clinical Research Community, In an increasingly complex regulatory environment, it can be difficult to stay on top of and to navigate all the federal, state, and institutional regulatory news and trends in clinical research. To address this challenge, the CRSO has added a new regulatory blog to their website that will deliver timely, … Continued

  • SOM PaTS: Please update your profile now

    Dear SOM Clinical Research Community, We are pleased to announce the release of the new SOM Profile and Training System (PaTS)! You may recall the release of a similar system last summer, which unfortunately was unable to meet the needs of the SOM community. We hope that you will find the new system easy to … Continued

  • Resource Hub: CITI Training Modules

    Completion of the Human Subjects Protection (HSP) module from the Collaborative Institutional Training Initiative (CITI) is required to conduct human subjects research at UNC, but did you know that there are many other training modules available?

  • Clarification: New Requirement for Clinical Research Monitors

    Dear SOM Clinical Research Community, As follow-up to the message below, we would like to clarify that clinical research monitors working with all SOM studies are expected to comply with the new UNC Health policy requiring COVID vaccination, regardless of the monitor’s primary onsite work location. For example, if the monitor of a study led … Continued

  • Important Reminder: Research Billing Review

    Dear SOM Clinical Research Community, With the Inclusive Research Billing Review process that went live 4/11/2021, all UNC Health encounters for patients associated with a research study are reviewed centrally by the UNCH billing review team. This process promotes more accurate and timely review and routing of hospital charges for patients associated with research studies. … Continued

  • Important Notification: New Requirement for Clinical Research Monitors

    Research Colleagues: As valued partners of UNC Health and its affiliates, clinical research monitors are expected to remain in compliance with certain UNC Health safety requirements while visiting or working at any UNC Health facility. A recent revision to UNC Health’s immunization requirements now includes COVID-19 vaccinations. Effective fourteen (14) days from today, April 12, … Continued

  • Clinical Trialist Training Program – Deadline Extended

    Dear SOM Clinical Research Community, The application deadline for the Clinical Trialist Training Program has been extended to April 7th, 2022. What does the opportunity offer? 10% protected time for clinical trial activities for 1 year (including 5% departmental match) Participation in a Clinical Trials Bootcamp Deep-dive educational sessions throughout the year Routine mentoring and … Continued

  • Identifying Legally Authorized Representatives

    The requirement to obtain legally effective informed consent from participants in clinical research is one of the central protections provided under the regulations. When it has been determined that a prospective participant does not have the capacity to provide legally effective informed consent, informed consent must be obtained from a legally authorized representative (LAR). Do you know how to determine who would be considered an acceptable LAR?

  • Annual SOM Clinical Research Staff Satisfaction Survey

    Dear SOM Clinical Research Community, In February 2021, we collected survey responses to assess job satisfaction among clinical research staff. Those responses have helped inform various CRSO initiatives, including offering ACRP memberships for SOM staff, developing a Personnel Profile and Training System (PaTS), and other ongoing efforts. We are asking you to complete this survey … Continued

  • Clinical Trialist Training Program: RFA Now Open

    The CRSO, NC TraCS, and LCCC are pleased to announce a training opportunity for SOM faculty interested in becoming a site investigator for multicenter clinical trials.  The Clinical Trialist Training Program provides 10% salary support for SOM faculty to participate in both didactic and experiential training and fosters the development of a clinical trial portfolio for … Continued

  • Reminder: Applications due Feb 18th for Professional Development Award- UNC NRP

    Eager to pursue a professional development opportunity but don’t have the funding? Let the UNC Network of Research Professionals help! The UNC NRP Professional Development award provides supplemental funding (in the form of reimbursement) to help cover development opportunities for UNC-CH or UNC Health employees whose work is focused on Human Subjects Research. The event … Continued

  • Qualifications and Training Documentation

    Lack of study team member qualifications and training documentation are the most common findings discovered in SOM clinical studies that are audited/reviewed by UNC’s Clinical Trials Quality Assurance (CTQA) program. In fact, incomplete and/or inaccurate qualifications and documentation of training were identified in 80% of the reviews conducted over the past 5 years. Take a moment to consider how you can ensure you are prepared and meeting the requirements.

  • NRP 2022 Professional Development Award- Now Accepting Applications- UNC NRP

    Colleagues, The UNC Network for Research Professionals is proud to announce our 2022 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; the event or opportunity … Continued

  • Update: SOM Financial Business Office Centralization of Post Award Invoicing for Clinical Trials- UNC NRP

    A point of clarification to the email regarding centralization of post award invoicing sent on December 16th. The SOM Finance Business Office Finance & Research Support Team (FiRST) will create and submit invoices, receive and reconcile payments, provide reports to study teams, and manage financial closeout for the SOM only. The OVCR Finance Service Center … Continued