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Resource Hub: CITI Training Modules

April 8, 2022

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

April 7, 2022

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

April 5, 2022

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

March 29, 2022

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

March 23, 2022

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

March 8, 2022

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

February 16, 2022

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

February 15, 2022

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

February 7, 2022

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

January 24, 2022

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.