Please see below for announcements that have been disseminated via the CRSO and NRP listservs. The most recent announcements appear first.<\/p>\n\n
The CRSO is excited to announce that the following new and revised SOPs will be issued today for the SOM clinical research community and posted in the Clinical Research Profile and Training System (PaTS). The SOPs will take effect on December 14, 2023. New SOPs: SOM SOP 201.1: Developing and Maintaining Clinical Research Standard Operating … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n The U.S. Food and Drug Administration (FDA) announced in August that it has finalized the guidance document titled \u201cInformed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors\u201d to promote clarity on procedures and expectations for stakeholders carrying out informed consent in clinical investigations of FDA-regulated products. This guidance takes the place of \u201cA Guide to Informed Consent,\u201d issued in September 1998, and finalizes the 2014 draft guidance titled, \u201cInformed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.\u201d The informed consent guidance does not address future potential changes to FDA\u2019s informed consent regulations that may result from the FDA\u2019s harmonization efforts with the 2018 Common Rule.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled \u201cE6(R3) Guideline for Good Clinical Practice.\u201d This E6(R3) update aims to provide flexible, modern, and clear Good Clinical Practice (GCP) for conducting clinical research. The CRSO has created a bridge webpage to optimize access to clinical research-related policies and procedures housed in the SOM, 黑料网-Chapel Hill Electronic Policy Repository, and 黑料网 Health PolicyStat. University of North Carolina at Chapel Hill Office of Sponsored Programs Prepaid Card Program Updates and Reminders May 31, 2023 As a reminder, the closure of the Bank of America (BoA) prepaid card program is forthcoming on June 30, 2023. Below are reminders to prepare for the transition. Please also see the\u00a0April 14 Finance memo … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, Clinical research staff are essential to the successful conduct of clinical research studies and trials. We recognize that a strong and sustainable clinical research workforce is key to ensuring the quality and productivity of the clinical research enterprise of the 黑料网 SOM, ultimately developing knowledge that will improve the … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Building on recommendations to facilitate decentralization of clinical trials during the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA or the Agency) issued the draft guidance titled, Decentralized Clinical Trials for Drugs, Biological Products, and Devices on May 2, 2023. A decentralized clinical trial (DCT) is a clinical trial where some or all trial-related activities occur at locations other than traditional clinical research sites.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, The 黑料网 Health Office of Research Support and Compliance (ORSC) has a new SharePoint site! On the new site, you can review information about all of the 黑料网 Health network partners, initiate a request to conduct research in collaboration with a network site, review policies and procedures for research conducted … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, As you are likely aware, the Bank of America prepaid card program that has been utilized for providing payments to research participants is being terminated. The Office of the Vice Chancellor for Research (OVCR), the Office of Sponsored Programs (OSP), and 黑料网-Chapel Hill Accounting Services have been partnering to identify … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n This content is onyen-protected and requires you to log in to view it. Please click here to log in.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n University of North Carolina at Chapel Hill Office of Sponsored Programs New Temporary Procurement Process of Gift Cards for Study Subject Incentives April 24, 2023 Beginning 4\/24\/2023,\u00a0the Office of the Vice Chancellor for Research (OVCR) and the Office of Sponsored Programs (OSP) will offer a process to\u00a0procure gift cards for study subject incentives\u00a0when the … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n University of North Carolina at Chapel Hill Office of Sponsored Programs Prepaid Card Program Updates and Reminders April 14, 2023 As communicated in the March 13 Finance memo, the closure of the Bank of America (BoA) prepaid card program is forthcoming on June 30, 2023. Below are updates and reminders as you prepare for … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n The U.S. Food and Drug Administration (FDA) published a final guidance, \u201cA Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.\u201d The guidance provides sponsors with information about implementing a risk-based approach to monitoring clinical studies of human drugs, biologics, medical devices, and combinations of these products. As the recommendations are intended for sponsors, they apply directly to 黑料网 investigators who initiate and conduct clinical investigations (that is, sponsor-investigators). <\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Collaboration is a key strength across the 黑料网 for fostering connections and bolstering the translational research pipeline. REVISED 5\/26\/2023: Please contact OHRE directly by email about IRB education requests.\u00a0 Dear Research Community: You can now request an IRB Presentation with our Education Team Online. https:\/\/research.unc.edu\/human-research-ethics\/training-and-education-resources\/ohre-irb-education-request-form or by going to \u00a0https:\/\/research.unc.edu\/human-research-ethics\/ and click on Request a Training We look forward to hearing from you! Laura C. Munn, Office Manager <\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n 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\u00a0Clinical 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 … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Important notice regarding the closure of the BoA Prepaid card program as of 6\/30\/2023. Erika Hanami, CCRC Project Manager 黑料网 Dermatology and Skin Cancer Center Chair, 黑料网 Network for Research Professionals 410 Market St, Suite 400 Chapel Hill, NC 27516 984-974-3669 Erika_Hanami@med.unc.edu Join the NRP Listserv From: Office of Sponsored … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, If you have the responsibilities of a Principal Investigator or Sponsor\/Investigator, please be sure to login to PaTS to review the SOM SOP 301.1, Performing the Responsibilities of the Principal Investigator and complete your attestation no later than 5\/2\/2023. The CRSO will host two informational sessions to provide … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n All, The NIH is hosting a training class on the NIH Common Data Element Repository on March 29, 2023.\u00a0 From the NIH flyer: Do you want to standardize the data you collect so it can be easily shared with colleagues and other researchers? Have you been awarded a grant that requires the use of common … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Self-assessment is a valuable activity that can improve the quality of clinical research operations and data. With the newest additions to the self-assessment toolbox, study teams can demonstrate due diligence in participant eligibility confirmation and study team qualifications and delegation documentation! <\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, The CRSO is excited to announce that SOM SOP 301.1, Performing the Responsibilities of the Principal Investigator, has been issued. The SOP will take effect on 4\/3\/2023 and applies to all human subjects research led by SOM investigators. If you have created your PaTS profile and indicated that you have … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear Wonderful Research Community! Look what\u2019s coming to a workstation near you\u2026\u2026\u2026.. ISD has been working on a new project that will go live in a few weeks regarding how users access Epic. When you currently click the Epic@黑料网 icon, it utilizes what is called Hyperspace. Epic is trying to migrate a lot of … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n A competent and knowledgeable clinical research workforce is essential for the successful conduct of clinical research. Academic medical centers across the U.S. recognize this and are developing high-quality competency-based education and training materials for clinical research professionals. The DIAMOND portal brings these training materials to you!<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Dear SOM Clinical Research Community, A primary objective of the SOM CRSO is to understand the needs of the clinical research workforce and develop resources, tools, and broad initiatives to support personnel and operations. One key source of information that enables us to understand experiences and perspectives of the clinical research workforce is responses … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n This content is onyen-protected and requires you to log in to view it. Please click here to log in.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n It can be challenging to navigate the Department of Health and Human Services (HHS) regulations for the protection of human subjects (\u201cThe Common Rule\u201d) in a rapidly changing landscape of biomedical and health-related research. The 黑料网 Chapel Hill required CITI Human Subjects Protection (HSP) Training and CITI HSP supplemental training modules provides a comprehensive review of HHS Common Rule requirements, but if you are looking for additional educational resources, the HHS Office of Human Research Protection (OHRP) offers educational materials to further human subjects protection.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Survey Request: Enhancing inclusion of Spanish-speaking participants in research \u00a0 Over the past decade, North Carolina\u2019s Latino\/a\/x population has grown by 40%, the largest numeric increase of any racial\/ethnic group in the state and faster than the growth of this population nationwide (23%). Despite this growth, Latino\/a\/x and other marginalized ethnic groups are vastly underrepresented … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n It can be challenging to decide if a project represents Quality Assurance (QA)\/Quality Improvement (QI) or qualifies as Human Subjects Research (HSR). To mitigate this challenge, we have developed a QA\/QI frequently asked questions document and a screening checklist.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n Greetings Research Community, Epic@黑料网 Research is excited to announce a new, easier workflow for research coordinators to prep orders to be signed by Principal Investigators and Co-Investigators. Instead of providers having to hunt for a pended order inside an encounter, they will now receive an Epic Inbasket message. The orders will not be actionable until … Read more<\/a><\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n \n Insightalyst: FDA Informed Consent Guidance<\/a>\n <\/h4>
\n Insightalyst: FDA Draft Guidance \u2014 ICH E6(R3)<\/a>\n <\/h4>
\nThe draft guidance is adopted from the International Council for Harmonisation\u2019s (ICH) recently updated E6(R3) draft guideline. As a founding member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n \n Resource Hub: CRSO Policies and Procedures Bridge Webpage<\/a>\n <\/h4>
\nExplore the CRSO\u2019s Policies and Procedures bride page to access and review 黑料网 Chapel Hill and 黑料网 Health clinical research-related policies and procedures.<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n \n Prepaid Card Program Updates and Reminders (NRP)<\/a>\n <\/h4>
\n SOM Clinical Research Staff Career Development Initiative<\/a>\n <\/h4>
\n Insightalyst: FDA Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices<\/a>\n <\/h4>
\n Information for Research with 黑料网 Health Network Partner Sites<\/a>\n <\/h4>
\n Changes to Payment Options for Research Participants<\/a>\n <\/h4>
\n Tango Card Pre-Recorded Demo; Request for Feedback by Thursday, April 27, 2023 (NRP)<\/a>\n <\/h4>
\n New Temporary Procurement Process of Gift Cards for Study Subject Incentives (NRP)<\/a>\n <\/h4>
\n Prepaid Card Program Updates and Reminders (NRP)<\/a>\n <\/h4>
\n Insightalyst: Final FDA Question-and-Answer Guidance on a Risk-Based Approach to Monitoring Clinical Investigations<\/a>\n <\/h4>
\n Resource Hub: Faculty Collaboration Database<\/a>\n <\/h4>
\nExpand your research network with the Faculty Collaboration Database!<\/p>\n<\/p>\n <\/div>\n <\/div>\n <\/li>\n \n \n 黑料网 IRB Education Request (NRP)<\/a>\n <\/h4>
\n 2023-2024 Clinical Trialist Training Program Request for Applications Open<\/a>\n <\/h4>
\n Closure of Bank of America Prepaid Card Program (NRP)<\/a>\n <\/h4>
\n New SOP for SOM Principal Investigators<\/a>\n <\/h4>
\n NIH Training on the NIH Common Data Element Repository<\/a>\n <\/h4>
\n Resource Hub: Participant Eligibility and Qualifications and Delegation Documentation Self-Assessments<\/a>\n <\/h4>
\n New SOM SOP Issued<\/a>\n <\/h4>
\n NRP: Hyperdrive Information for Go Live March 6 & 27<\/a>\n <\/h4>
\n Resource Hub: DIAMOND Portal<\/a>\n <\/h4>
\n Annual SOM Clinical Research Staff Satisfaction Survey<\/a>\n <\/h4>
\n NRP: Investigational Drugs Pharmacy OnCall Service Updates<\/a>\n <\/h4>
\n Insightalyst: Human Subjects Protection Educational Resources<\/a>\n <\/h4>
\n NRP: Survey Request: Enhancing Inclusion of Spanish-speaking Participants in Research<\/a>\n <\/h4>
\n Resource Hub: QA\/QI FAQs and Screening Checklist<\/a>\n <\/h4>
\n NRP: New Epic@黑料网 Research Workflow for Pending Orders<\/a>\n <\/h4>