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Memo: IDS Logistical Plans for Future Studies at Eastowne (NRP Listserv)

March 15, 2021

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

Requirement for Advance Approval of Electronic Solutions

March 2, 2021

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

IDS Pickup Procedures Updated (NRP Listserv)

February 24, 2021

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

Did You Know- Department Routing of IRB Submissions (NRP Listserv)

February 23, 2021

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

SOM Clinical Research Staff Satisfaction Survey

February 18, 2021

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

Clinical Trialist Training Program

February 11, 2021

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

Did You Know? Changes to Multi-Site Screening Question (NRP Listserv)

January 20, 2021

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

CRSO Resource Hub: Best Practices for Conducting Clinical Trials During the COVID-19 Pandemic

January 19, 2021

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.”

IRBIS Update and JIT/118 Application (NRP Listserv)

January 15, 2021

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