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Resource Hub: Flexible Work Options Playbook

September 19, 2022

As remote and hybrid working is becoming the “new norm” for many SOM clinical research teams, it is important to find team-oriented solutions that encourage employee productivity and growth.

Important Change to Billing Coverage Analysis (BCA) Requests (NRP Listserv)

September 8, 2022

Dear UNC Research Community, Effective September 12, 2022, the process for requesting a Billing Coverage Analysis (BCA) will change.  We are now utilizing the Service Now ticketing system for all BCA requests. This system will make it easier for the Research community by providing one central location to submit a BCA request. The below link … Continued

Use of Non-UNC Email for Research

September 6, 2022

Dear SOM Clinical Research Community, Please be sure to review the announcement below regarding the requirement to utilize only UNC email addresses for communicating with research participants via email. -SOM CRSO   [FORMAL NOTICE] Use of non-UNC Email for Research   Use of non-UNC Email Accounts for Research Recruitment Recruitment of subjects for research is … Continued

Town Hall: One UNC Clinical Research

August 18, 2022

The Research Integration Team invites you to join an interactive conversation about the One UNC Clinical Research Initiative between the Office of the Vice Chancellor for Research, School of Medicine, and Healthcare System. All are encouraged to participate, share thoughts, and ask questions.   Wednesday, September 14, 2:00-3:00 PM Click here to register Click here … Continued

Resource Hub: Phone.com as Texting Platform

August 11, 2022

As clinical research methods and standards strive to keep pace with the needs of our research participants, it is important to consider communication preferences. Text messaging with participants is an often desired method of communication and can bolster participant understanding and compliance with study activities. UNC-CH has completed a security review and executed a Business Associate Agreement (BAA) with Phone.com to permit this service to be utilized for communication with research participants.

In the Know: Clinical Trial Requirement to Post Informed Consent Form

July 19, 2022

Most research teams are aware of the requirements to list clinical trials and upload results to clinicaltrials.gov, but did you know you are also required to post the consent form? The 2018 Requirements state that a consent form must be posted to a designated federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.

Resource Hub: Informed Consent Self Assessment Tool

June 30, 2022

Self-assessment is a valuable activity that can be informative in a variety of settings, including informed consent for clinical research. Now you can proactively discover your informed consent process strengths and areas for improvement using a new Informed Consent Self-Assessment tool!

Did You Know? Investigator Brochure Updates (UNC OHRE)

June 29, 2022

How do I submit my Investigator’s Brochure (IB) update to the IRB? Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)? It depends… IBs are reviewed annually and may be updated with Investigational Product (IP) information which does … Continued

Resource Hub: New Clinical Research Glossary

June 20, 2022

Whether you are new to clinical research or an experienced member of the research team, mastering the highly specialized vocabulary (and alphabet soup!) of clinical research and using it effectively in professional communications can be challenging. To bolster understanding and facilitate effective communication in the SOM and beyond, we have created a concise and organized glossary of clinical research terms that aligns with industry and regulatory standards.

Important – IV Contrast Update (NRP Listserv)

June 16, 2022

Update regarding the shortage of contrast media from Lauren M.B. Burke, MD, FSAR, executive Vice Chair of Radiology In the last few weeks, GE has increased production of Omnipaque 300 and 350, the most common contrast media concentrations used in Imaging Services, with production currently at or above 75% of typical production.  UNC has been … Continued