Greater Nashville Area
SOCRA Greater Nashville Regional Chapter
How Regulations Impact Clinical Studies
Speaker: Sylvia L. Johnson, BS MSTM
CEO/President of JI-Solutions LLC
Thursday, April 25, 2019
12 - 1pm
8380B Medical Center East
Vanderbilt University Medical Center
Clinical research studies must follow the federal regulations. The speaker will review the roles the FDA, Sponsor, and the IRB have in clinical research oversight.
By the end of the lecture, the attendee will be able to understand:
* Clinical Study Oversight
* FDA Site Inspection
* Role of the FDA/Sponsor/IRB
* What Drives a Successful Clinical Study
* What are the Real Expectations
Accreditation and Credit Designation: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education through the joint providership of Vanderbilt University School of Medicine and the Society of Clinical Research Associates. Vanderbilt University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
Vanderbilt University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Faculty Disclosure Statement: It is the policy of the ACCME and Vanderbilt University School of Medicine to require disclosure of financial relationships from individuals in a position to control the content of a CME activity; to identify and resolve conflicts of interest related to those relationships; and to make disclosure information available to the audience prior to the CME activity. Presenters are required to disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentations.
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 email@example.com .
CE: SOCRA has approved this program for 1.0 continuing education contact hour for members. Please share this announcement with your colleagues.