Colleagues – By now many of you have heard of the project to implement OnCore, an enterprise-class clinical research management system. Once implemented, OnCore will help the University better manage clinical research by increasing efficiency and compliance, as well as providing for better reporting and analytics of Carolina’s clinical research portfolio. The implementation of this … Continued
Dear SOM Clinical Research Community, While email is an essential communication method, keeping track of and referring back to important information disseminated via listserv emails can be challenging. To address this challenge, we are pleased to share the new “Announcements” page on the CRSO website. Here you will find a chronological listing of all informational … Continued
Dear SOM Clinical Research Community, We are writing to update you on the status of the SOP for Informed Consent of Adult Participants that has been in development for some time. We received thoughtful, valuable feedback from the SOM community that enabled finalization of a comprehensive and concise SOP that has since been approved by … Continued
The IRB Meetings and Deadlines Calendar has been published for 2022 on the OHRE website. Please note that receipt by the submission deadline does not guarantee review at the corresponding meeting. Once a full board agenda is full, it is closed; subsequent submissions are assigned to the next available agenda. You may notice that some … Continued
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 handles this reporting requirement. In order for the University to … Continued
Dear SOM Clinical Research Community, The University of North Carolina recently licensed OnCore, an enterprise clinical trial management system, with the aim of deploying the platform across the entire campus. With OnCore, we will be able to reduce administrative burden, improve operational efficiencies, better understand UNC’s clinical research portfolio, and strategically pursue areas of growth. … Continued
Dear SOM Clinical Research Community, We are pleased to announce individual awardees of the one-year ACRP membership benefit granted by SOM CRSO and NC TraCS. The awardees each demonstrated a commitment to the field clinical research at UNC, a desire to further develop clinical research skills and knowledge, and a vision for continuous quality improvement … Continued
On 11/7/21, there will be a new Epic Release. There are minimal visual changes for Research Functionality. Please review: Research Release Highlights Fall 2021.pdf If you want to see the changes in action, Go Play!
Dear SOM Clinical Research Community, The slides and recording from last week’s CRSO Town Hall may be accessed here: https://www.med.unc.edu/crso/about-us/crso-town-hall-recording-and-slides/ (onyen login required). Thank you for the questions and discussion – as always, please reach out anytime! -SOM CRSO
This is a reminder, if there have been changes to your study or you have noticed an error or omission on a BCA previously completed please reach out to the BCA team at firstname.lastname@example.org Please include the CRMS and IRB numbers in your email.
On October 1, 2021 the UNC-Chapel Hill OHRE released the newest version of SOP 1401 – Promptly Reportable Information. This replaces SOP 1401 – New Safety Information and is in effect as of October 1, 2021. This revision was done to align definitions across collaborating institutions, comply with FDA requirements and recent guidance, and enhance … Continued
On September 30, 2021, the U.S. Food and Drug Administration (FDA) issued new draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance addresses how
investigators must assess and report adverse events to ensure participant safety in drug and device studies.
The UNC Health Care System (UNCHCS) includes hospitals across the state that serve the people of North Carolina. Conducting research activities at locations outside of the UNC Chapel Hill Medical Center can broaden the impact and diversity of your study data. The UNCHCS Office of Research Support and Compliance (ORSC) serves to enable research in the network entities.
Dear All, Please see below information from Tess Cummings, Director for the UNC Lineberger Clinical Protocol Office. Tess has done an outstanding job in pulling the SIP process and requirements together, her tireless efforts are much appreciated. Many thanks, Christine Nelson ********************************************************************************************************************** Good Morning UNC Research Community, As many of you have heard, several … Continued
Dear SOM Clinical Research Community, As part of our mission to promote continuous professional development and a culture of quality across the SOM, the CRSO and NC TraCS are partnering to offer 5 individual year-long ACRP memberships to SOM clinical research staff. ACRP membership offers access to vast e-learning courses, webinars, an online community of … Continued
Hi everyone, Please keep an eye out for updated Epic Details Bills for your research studies that include the research pricing. Thanks for patience while this issue was resolved. Thanks! Epic@UNC Research Team EpicUncResearch@unchealth.unc.edu
Dear SOM Clinical Research Community, As a reminder, Andy Thorne, previous Clinical Manager of the UNCH Investigational Drug Pharmacy (IDS), is no longer at UNC. Please make note of new contact information for IDS. IDS pharmacy leads: Cancer IDS: Sharon Guerry (Sharon.Guerry@unchealth.unc.edu) General IDS: Maria Bullis (Maria.Bullis@unchealth.unc.edu) For general questions: Cancer IDS: NConcologyIDS@unchealth.unc.edu … Continued
Research community at UNC, I will be departing UNC Health after this week. I am proud to have worked with so many of you on meaningful research that is helping to shape the future of medicine and positively impacting the lives of our patients. I am happy to share that two IDS pharmacists have been … Continued
Dear SOM Clinical Research Community, 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 … Continued
Dear SOM Clinical Research Community, If you have not yet completed your personnel profile in the new SOM Personnel Profile and Training System (PaTS), please take a few minutes to do so by the end of this week: https://crso.unc.edu/pats Thank you to all who have already completed a profile – currently 620 SOM faculty and … Continued
Dear SOM Clinical Research Community, Please take a moment to review the information about the PaTS system in prior announcements and complete your profile at https://apps2.research.unc.edu/crso/. All SOM faculty and staff involved in the conduct of human subjects research are asked to complete a profile no later than July 30th. FAQs Q: If my research … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
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 … Continued
UNC Clinical Research Community, In an effort to continuously improve process to maintain reliability and provide the most efficient path to study opening, UNC Investigational Drug Services (IDS) is working with UNC ISD Epic builders to streamline the process of requesting new build in Epic for study drug ordering. Currently, requests for new drug build … Continued
Dear SOM Clinical Research Community, In early March we administered a survey to assess job satisfaction among clinical research staff. We received 102 complete responses, including many valuable and insightful open-ended comments. The survey findings suggest that the highest levels of satisfaction relate to workplace recognition (e.g. opportunities to contribute to important human subjects research … Continued
The 21st Century Cures Act enables patients to easily and quickly access their own health records. At UNC, notes and results will be shared once finalized in Epic, but NOT research notes. Make sure you’re in the know!
The requirements for obtaining and documenting informed consent for research studies are defined by the FDA, DHHS, ICH GCP, and local IRBs. The requirements vary depending on the exact study characteristics. Knowing what applies and how to operationalize the required procedures for various studies can seem overwhelming, but there are some general best practices to keep in mind!
The UNC-Chapel Hill Office of Human Research Ethics (OHRE) is excited to announce a large enhancement in IRBIS is expected to go live the evening of May 6th, 2021. This update is based on feedback from our research community and will allow for a personnel modification to be processed at the same time and be … Continued
NRP Did you Know? What are Data Security Contacts and Who Are They? The IT Data Security Contacts are individuals who have been identified by IT leadership in your school, center, or institute for your administering department. These individuals assist the PI with ensuring their research data are properly safeguarded. PIs and project coordinators are … Continued
Dear SOM Clinical Research Community, Please carefully review the announcement shared below from the UNC Office of Clinical Trials and UNC Health. **UPCOMING CHANGES TO BILLING COVERAGE ANALYSIS and CHARGE REVIEW PROCESSES** The Office of Clinical Trials and UNC Health announce upcoming changes to the billing coverage analysis and charge review processes effective April 11, … Continued
Dear SOM Clinical Research Community, Please see the below information disseminated today from Carolina Leadership: “While the University is not requiring the COVID-19 vaccine for students, faculty or staff, it is helpful to know the percentage of the community that is vaccinated. UNC Environment, Health and Safety has set up a website where employees can … Continued
Dear UNC clinical research community, Please see attached a memo detailing future logistical plans for IDS support of clinical trials at Eastowne. We are excited to be supporting the Eastowne initiative and to work with you in shaping the future of medicine. Best, Andy Thorne, PharmD, MS
Dear SOM Clinical Research Community, Please see attached letter from Senior Associate Vice Chancellor for Research, Andy Johns regarding requirement for approval for clinical research support systems. The notice requires that any unit which proposes to purchase or implement any electronic system or solution for the support of clinical research must request (in advance) approval … Continued
UNC Research Community, Beginning next week on Friday 3/5, we will transition to a new pickup procedure for our 3West and Neurosciences hospital IDS locations. Each IP pickup will require verbal confirmation of two patient identifiers: name, DOB, MRN, and/or subject ID. The person picking up from the IDS pharmacy will be required to sign … Continued
A department’s approval in IRBIS is attesting that the study personnel have the appropriate expertise (e.g., credentialing, licensure, privileges, training), experience (e.g. previous research studies conduct and role in relation to risk level of research), and resources (e.g. committing staff’s time to appropriately provide oversight, departmental funds if applicable) to conduct the study appropriately and … Continued
Dear SOM Clinical Research Community, A major initiative of the CRSO is to support the clinical research workforce through offerings of training materials and courses, development of resources, and implementation of career pathways for research staff. One potential impact related to these initiatives may be improved job satisfaction. We have developed a survey to assess … Continued
The CRSO and NC TraCS are pleased to announce a new 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
Dear UNC Research Community, Last year, IDS implemented a new billing model on October 1, 2020 that applies to all new studies for which a pharmacist assignment was made on or after Oct 1, 2020. In line with that update, recent changes have been made to the CRMS form to request IDS services. These changes … Continued
The original purpose of the Multi-Site Screening question (#6 on the Screening Questions page) was to distinguish studies that were being conducted at multiple sites from single-site studies. The question was changed last year to address only those instances where UNC is overseeing multiple sites. Older studies were “grandfathered” and were not required to update … Continued
Conducting clinical research during the COVID-19 pandemic has required us all to adapt and modify our approaches in the conduct of our research in order to successfully navigate the challenges we have faced. As researchers across the nation faced similar challenges, the Clinical Trials Transformation Initiative (CTTI) worked to offer support and also collect information associated with these challenges and solutions. These initiatives and resulting best practices are captured in a new playbook, “Best Practices for Conducting Trials During the COVID-19 Pandemic.”
Dear Members of the Research Community, As part of the OHRE’s goal to reduce unnecessary burden and ensure our processes are effective, we continued reviewing application forms to identify improvements and reduce duplication. We started with moving toward application types (e.g., JIT, NHSR, Full Form) and continued by revising the Rely-on applications and in 2019-2020 … Continued
Dear SOM Clinical Research Community, In planning for spring semester, UNC HR recently disseminated new resources and policies to support students and employees navigating changes associated with COVID-19. UNC employees whose work requires them to report to campus are now required to complete a daily wellness assessment at ehs.cloudapps.unc.edu/UEOHC/covid19wellness. Utilization of this new web portal … Continued
Research studies that are considered FDA-regulated are required to comply with specific FDA rules and regulations. It is imperative that the PI and study team understand what applies and how to maintain compliance. Is your research FDA-regulated?
Many research participants are also patients undergoing clinical care. Many study investigators are also clinicians providing clinical care. When is it important to clearly delineate between clinical research and clinical care? Always!
With increased needs for technology solutions and electronic tools for conducting clinical research, it is important to recognize who has responsibility for determining if those tools are appropriate for clinical research use. Hint, it’s not the IRB.