Announcements
Please see below for announcements that have been disseminated via the CRSO and NRP listservs. The most recent announcements appear first.
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2023-2024 Clinical Trialist Training Program Request for Applications 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 … Continued
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New SOP for SOM Principal Investigators
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 … Continued
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Resource Hub: Participant Eligibility and Qualifications and Delegation Documentation Self-Assessments
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!
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New SOM SOP Issued
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 … Continued
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NRP: Hyperdrive Information for Go Live March 6 & 27
Dear Wonderful Research Community! Look what’s coming to a workstation near you……….. 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@UNC icon, it utilizes what is called Hyperspace. Epic is trying to migrate a lot of … Continued
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Resource Hub: DIAMOND Portal
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!
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Annual SOM Clinical Research Staff Satisfaction Survey
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 … Continued
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NRP: Investigational Drugs Pharmacy OnCall Service Updates
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Insightalyst: Human Subjects Protection Educational Resources
It can be challenging to navigate the Department of Health and Human Services (HHS) regulations for the protection of human subjects (“The Common Rule”) in a rapidly changing landscape of biomedical and health-related research. The UNC 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.
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NRP: Survey Request: Enhancing Inclusion of Spanish-speaking Participants in Research
Survey Request: Enhancing inclusion of Spanish-speaking participants in research Over the past decade, North Carolina’s 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 … Continued
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Resource Hub: QA/QI FAQs and Screening Checklist
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.
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NRP: New Epic@UNC Research Workflow for Pending Orders
Greetings Research Community, Epic@UNC 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 … Continued
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Resource Hub: CRAU Directory
As clinical researchers, a large part of what we do involves working together through collaboration, mentoring, and direct support. However, it can be challenging to identify the right person for a specific activity. The School of Medicine (SOM) CRAU Directory mitigates this challenge by enabling you to identify personnel with specific expertise and responsibilities across the entire SOM.