Greater Nashville Area

SOCRA Greater Nashville Regional Chapter

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

1. The meetings will be conducted remotely via Zoom. (link: https://zoom.us/j/2109046164  )
2. In order to register for the meeting please complete the following REDCap survey: https://redcap.vanderbilt.edu/surveys/?s=E89L87XWPW upon registration completion a meeting password 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:

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 for the July 22 meeting, the code is valid for 24 hours.

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Webinar: FDA Oversight of Digital Health Products: Software as a Medical Device

Rachel Johnson, PhD, RAC
Trial Innovation Network

 July 16, 2020, 1 - 2 pm Central

The presentation will cover FDA's regulatory approach for digital health products, including mobile apps and software functions intended to be used for clinical decision support or to promote general wellness. The presentation will provide an overview of the regulatory requirements for both conducting clinical studies and commercializing mobile medical apps.

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Clinical Trial Monitoring and Implementation of Remote Monitoring at VUMC

Speaker:   Eli Po'e, BS
Research Clinical Navigator, CRFSS/VICTR
Vanderbilt University Medical Center

Wednesday, July 22, 2020, 12 - 1 pm Central

The monitoring of clinical trials is critical to ensure data quality within a study. The speaker will discuss the purpose and the importance of clinical trial monitoring, and how remote monitoring has been implemented at VUMC.

After this session, participants should be able to:

• Describe the purpose of clinical trials monitoring
• Understand Principal Investigator and Sponsor obligations
• Describe how clinical trial monitoring has been implemented at VUMC
• Discuss the benefits and challenges of remote monitoring

 

Commercial Support: This educational activity received no commercial support. All course speakers indicated no financial relationships to disclose.

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

CE: SOCRA has approved each program for 1.0 continuing education contact hour for members. Please share this announcement with your colleagues.