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This co-sponsored virtual symposium is a distinct opportunity for Sponsor-Investigators and key research staff to receive targeted training directly from FDA, NIH, and research industry representatives. It will provide insight into the unique dual-role of sponsor-investigators with in-depth coverage of the applicable FDA regulations, guidelines, and best practices. Attendees will take away tools for designing and managing quality research studies that will produce accurate and complete data submissions. The three (3) half-day schedule allows for less disruption to clinical practice and continuing education credits (CME/CNE/SOCRA CE) apply.

Enhanced understanding and application of both the sponsor and clinical investigator research responsibilities, by sponsor investigators, will strengthen the likelihood of: compliance with regulations, incorporation of quality aspects in research design and submissions, provide key principles for study start-up; proper study conduct and integrity of data, appropriate inclusion of  risk-based monitoring techniques and processes, along with ensuring the protection of human research subjects rights, safety and welfare. As a result, this provides FDA with the data on which to base its decisions regarding the acceptability of marketing applications. 

CE Credit:  SOCRA designates this educational activity for a maximum of 13.0 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 13.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audience: Sponsor-Investigators, IRB Administrators and Staff, Clinical Research Coordinators, Clinical Research Associates, and other professionals involved in FDA regulated research involving Sponsor-Investigators.