Greater Nashville Area

SOCRA Greater Nashville Regional Chapter

In compliance with Covid-19 social distancing requirements, the following process will be followed:

1. The meetings will be conducted remotely via Zoom.
2. In order to register for the meeting please complete the following REDCap survey https://redcap.vanderbilt.edu/surveys/?s=8MAPKYLMN4YRH8LX upon registration completion a meeting password and the link to the meeting will be sent to the email entered into the survey.
3. Actual attendance will be documented via emailing kate.vonwahlde@vumc.org during or immediately following the meeting. Following the meeting:
    a. SOCRA members will be emailed a copy of the SOCRA attendance certificate
    b. Non OoCRA members track attendance via VUMC CME website and/or their own CE tracking method.
    • A unique VUMC CME code will be provided during the June 15 meeting, the code is valid for 24

ClinicalTrials.gov – How To Be Compliant with Clinical Trial Results Reporting Requirements

Speakers:
Natalie Dilts, MPH
Christelle Scott, BS
David Crenshaw, MSW
Vanderbilt University Medical Center
June 15, 2023 │ 12-1 pm Central

Federal regulations and NIH policies mandate clinical trial results reporting for most interventional trials. ClinicalTrials.gov is a free registry that can be utilized to meet these regulatory requirements. This workshop will briefly introduce the ClinicalTrials.gov platform, identify the types of trials requiring results reporting, demonstrate how to report clinical trial results, and discuss how to maintain results reporting compliance.

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Webinar: Decentralized Clinical Trials (DCT) Draft Guidance

Speakers:
Leonard Sacks, MBBCh
Associate Director, Clinical Methodologies, Office of Medical Policy (OMP)/CDER/FDA
Ryan Robinson, MD
Medical Officer, Clinical Methodologies/OMP/CDER/FDA
June 20, 2023 │ 2-3 pm Central

The FDA sees important potential benefits and value in DCTs. Advances in clinical care using electronic communications and information technology to interact with trial participants in different locations (i.e., telehealth) allow for fewer in-person visits to clinical trial sites and facilitate decentralization. In addition, digital health technologies have expanded the types of trial-related data that can be obtained remotely from trial participants. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility. As part of the FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
TOPICS COVERED

•  Conduct of remote clinical trial visits and clinical trial-related activities in a DCT
•  Use of digital health technologies to remotely acquire data in a DCT
•  Roles and responsibilities of the sponsor and investigators in a DCT
•  Obtaining informed consent and institutional review board oversight of the informed consent process in a DCT
•  Safety monitoring of trial participants in a DCT
•  Software used to support the conduct of a DCT

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Webinar: Effectively Measuring Trust and Trustworthiness in Research Among Minoritized Racial and Ethnic Groups

Speaker:
Consuelo H. Wilkins, MD, MSCI
Vanderbilt University Medical Center
Trial Innovation Network
June 21, 2023 │11 am Central

Lack of trust in research and concerns about the trustworthiness of researchers and research institutions are commonly cited barriers to enrolling in research studies. Trust in biomedical research has been lower among minoritized racial and ethnic groups who have been historically underrepresented and excluded from research. Effectively measuring trust in biomedical research requires instruments that include content areas reflecting minoritized racial and ethnic populations’ definitions and perceptions of trust. We developed the Perceptions of Research Trustworthiness (PoRT) Scale, a validated tool to measure trust in biomedical research that is relevant across Black, Latino, and White communities, including those with lower educational attainment. The goal is to more accurately measure trust and subsequently enable strategies aimed at increasing trust and trustworthiness to be evaluated and monitored.
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Accreditation:
Vanderbilt University Medical Center is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Vanderbilt University Medical Center designates this live activity for a maximum 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Commercial Support: This activity received no commercial support.
Financial Disclosures: Faculty and planners for this event have the following disclosures:

Name of individual / Individual's role in activity Name of commercial interest/Nature of relationship
Annette Oeser, MS Faculty: Nothing to disclose - 09/12/2022
Natalie Dilts, MPH Faculty: Nothing to disclose – 12/27/2022
Christelle Scott, BS Faculty: Nothing to disclose – 08/05/2022
David Crenshaw, MSW Faculty: Nothing to disclose – 08/18/2022

Attendance: Members and non-members welcome. Please bring your lunch. For directions, please contact wendy.lloyd@vumc.org .
CE: SOCRA has approved this program for 1.0 continuing education contact hour for members. Please share this announcement with your colleagues.

Future Correspondence: SOCRA has sent this email for educational purposes only. If you no longer wish to receive emails from SOCRA, please contact the SOCRA office at office@socra.org.