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. 2. In order to register for the meeting please complete the following REDCap survey https://redcap.vanderbilt.edu/surveys/?s=M837WHP3WCPL83CJ   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 vonwahlde@vumc.org during or immediately following the meeting.  Following the meeting:
   1. SOCRA members will be emailed a copy of the SOCRA attendance certificate
   2. Non SOCRA members track attendance via VUMC CME website and/or their own CE tracking method.
   3. A unique VUMC CME code will be provided during the August 25 meeting, the code is valid for 24 hours

Webinar: Diversity and Inclusion in Clinical Trials — Practical Steps for Patient Recruitment Strategies

Speakers:
Dustin Owen, Senior VP and GM, Accelerated Enrollment Solutions
Brittany Erana, SVP Digital and Decentralized Solutions, PPD, ThermoFisher
Lloryn Hubbard, Associate Director Patient Solutions, PPD, ThermoFisher XTalks

Wednesday, August 10, 2022 10 am Central

In April 2022, the US Food and Drug Administration (FDA) published a draft guidance recommending the development of diversity plans in clinical research programs. This guidance provides biopharma and biotech companies with an understanding of what the plan should include to ensure participants from underrepresented racial and ethnic populations (Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian/Pacific Islanders and other persons of color) are represented in US clinical trials.

Research shows that adequate representation of diverse populations in clinical trials provides data heterogeneity, reflects real world patient populations, and can identify safety and efficacy outcomes that may be associated within certain groups. By incorporating diversity plans into drug development strategies we can strive to address these issues.

After the presentation, attendees should be able to:
• Describe what diversity and inclusion in clinical trials means, from a US and a global perspective
• Discuss the FDA’s diversity plan and what should be included in it
• Describe factors to consider when evaluating sites and patient recruitment partners supporting diverse enrollment
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Navigating the Review Process: The Scientific Review Committee, the IRB, and the DSMB

Speaker: Victor Santana, MD
Faculty, St. Jude Children’s Research Hospital, Departments of Global Pediatric Medicine and Oncology
Professor, University of Tennessee Health Sciences College, Department of Pediatrics
Co-Associate Dean, St. Jude Graduate School Biomedical Sciences, Master’s Program in Clinical Investigations

Thursday, August 25, 2022; 12-1 pm Central

Clinical trials are an important cornerstone in biomedical research and provide a mechanism to improve the health and well-being of our patients while advancing scientific discovery. Independent oversight of the review and approval process is necessary to provide the highest quality science and ethical research, resulting in clinical trials that are impactful whilst safeguarding the rights and safety of participants. Review committees play an important role in the study development and conduct. During this seminar we will contrast and compare the complementary and important roles for the Scientific Review Committee, IRB, and DSMB.

Objectives:
• Describe the key roles and responsibilities of the Scientific Review Committee, the IRB, and the DSMB in review and oversight of clinical trials.
• Identify the critical timepoints in the review process for initial and continued committee(s) oversight.
• Describe common concerns and information needs of the study staff in navigating the committee(s) review process.

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 - 01/04/2022
Victor Santana, MD Speaker: Nothing to disclose—07/29/2022

Attendance: Members and non-members welcome.  Please bring your lunch. For directions, please contact wendy.lloyd@vumc.org .

CME: 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.