Research November 2025 Newsletter

Surgical Research Career Advancements

• Katie Bower, MD MSc; Vice Chair of Surgical Research
• Sydney Webb, MPH; Director of Surgical Research
• Miebaka Roberts, MBBS MPH; Clinical Research Coordinator

Regulatory Workflow
 

Research Regulatory Affairs Specialists play a critical role in ensuring that clinical trials comply with all applicable regulations, guidelines, and institutional policies. The Research and Development Department at Carilion Clinic currently houses several regulatory affairs specialists to support the regulatory and compliance aspects of our sponsored clinical trials. They serve as a liaison between investigators, sponsors, local and central Institutional Review Boards (IRBs), and internal and external regulatory agencies to ensure that all research activities are conducted ethically and in accordance with federal, state, and institutional regulations.   Regulatory Affairs Specialists are available to help you with your regulatory needs from study start-up to closeout and beyond. For more information on the regulatory workflow of a clinical trial please click here

Updated Education for FDA Guidance Publication of ICH E6(R3) Good Clinical Practice (GCP)

In January 2025, the International Council for Harmonisation (ICH) published an updated guideline titled Guideline for Good Clinical Practice E6(R3) intended to outline flexible and modern good clinical practices for conducting clinical trials. On September 9, 2025, the Food and Drug Administration (FDA) published its final guidance for E6(R3) Good Clinical Practice as a guidance to industry. While not legally binding, adherence to these recommendations is expected of investigators conducting clinical trials to meet quality of safety standards, safeguard the rights of human participants, and ensure the reliability of trial results.   

Beginning October 15, 2025, completion of the Carilion Clinic CITI Good Clinical Practice basic or refresher course will include the recent E6(R3) changes.  Completion of this course is an institutional requirement for all key research personnel assigned to a clinical trial that involves the use of an FDA regulated product and/or receiving federal funding.

If your CITI certification for this course is not due to expire prior to December 31, 2025, you may receive training for the E6(R3) guidance via REDCap. An acknowledgement of your training, along with your signature can be emailed to you to be shared with your clinical trial sponsors to confirm your acknowledgement of this update in lieu of additional sponsor GCP training or retaking the entire CITI GCP course prior to expiration.

Carilion Clinic TriNetX
Virtual Training Schedule

Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so!  Let Dee Myers know which date you prefer and she will send a meeting invitation.

• Nov 6, 1:30 – 3pm
• Dec 17, 10:30am - noon

 https://redcap.link/v5pw9j7j to sign up for TriNetX digitally.

For more information visit:https://redcapweb.carilionclinic.org/redcap/surveys/?s=dcUCIpMAzk8BqKH2

You asked, we linked

Click on the social media icons below!