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

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

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

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?

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

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

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

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

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?

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