Greater Nashville Area
SOCRA Greater Nashville Regional Chapter
In compliance with Covid-19 social distancing requirements the following process will be followed:
- The meetings will be conducted remotely via Zoom. (link: https://zoom.us/j/2109046164 )
- In order to register for the meeting please complete the following REDCap survey: https://redcap.vanderbilt.edu/surveys/?s=T7CLMF3EPA , upon registration completion a meeting password will be sent to the email entered into the survey.
- Actual attendance will be documented via emailing kate.vonwahlde@vumc.org during or immediately following the meeting.
Following the meeting:
- SOCRA members will be emailed a copy of the SOCRA attendance certificate
- Non SOCRA members track attendance via their own CE tracking method.
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Webinar: Partner with the investigator to master virtual trials: Harness the perspectives of virtual and site-based investigators as you pivot to digital in the COVID-19 era
Thursday, June 4, 2020; 8 am Central
Speakers:
John Zibert, Chief Medical Officer, LEO Innovation Lab
Mads Dalsgaard, Senior Vice President, Lundbeck
Kai Langel, Director, Janssen Clinical Innovation
Jonathan Cotliar, Chief Medical Officer, Science 37
Vera David, Medical Director, Science 37
When it comes to digital initiatives, some things are certain. We know that technology alone is never enough. We know from countless attempts to digitize clinical trials that if we fail to tackle the human angle, fail to prioritize change management, fail to put ourselves in the patient's shoes, we will fail.
COVID-19 has forced everyone into a rapid virtualization of traditional studies. You might think that this sudden change means we should be led by technology and speed. Unfortunately, this is not the case. Many virtual trials are already doomed from having to pivot so quickly without due consideration to other key factors. To deliver high-performing trials, we need to learn from those with the most experience in converting trials to a home setting
Anybody can start a video call and talk to a patient. But to integrate the multiple stakeholders required to migrate a trial into a home setting, you need to draw on past learning. Science 37 is the organization with more virtual trial experience than any other, across many therapy areas. Join us for a free webinar as we explain honestly and transparently how early stumbling blocks and growing pains are now enabling rapid digital transformation that also comes with reliable outcomes.
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Webinar: When People are Data: How Medical History Matters for Our Digital Age
Tuesday, June 9, 2020; 10:00 am Central
Speaker: Joanna Radin, PhD- Associate Professor, Program in History of Science and Medicine, Yale University, National Institute of Health
This talk focuses on the history of a particular collection of data, extracted and digitized from patient records made in the course of a longitudinal epidemiological study involving Indigenous members of the Gila River Indian Community Reservation in the American Southwest. The creation, circulation, and eventual restriction of the Pima Indian Diabetes Dataset (PIDD) demonstrates the value of medical and Indigenous histories to the study of Big Data. The history of the PIDD reveals how data becomes alienated from persons even as it reproduces complex social realities of the circumstances of its origin.
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Webinar: How do I determine if I need an IND?
Thursday, June 18, 2020; 1:00 pm Central
Speaker: David Jensen, PhD, RAC
Trial Innovation Network
One of the most common questions from physician investigators is whether their study, which uses a legally marketed drug, needs to be run under an IND. They know that certain types of studies can be exempt from the IND regulations, but they don't know how to evaluate the criteria appropriately. During this forum, we'll identify and discuss the single key exemption criterion and evaluate that criterion for several case studies.
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.