Clinical Trial Series

Webinar 2: Clinical Trials Contracts, Negotiation and Administration

July 26, 2011

This Webinar will provide attendees with insights and decision‐making steps for negotiating clinical trial contracts. The instructor will take you beyond the contract to discuss clinical trial management issues that must be considered and provided for in negotiating the clinical trial contract, in order to prepare the path for effective and accountable clinical trial administration. She will discuss important, special contract terms and conditions applicable to clinical trial contracts, share the tools and tips of the trade, and focus on potential problem areas. Topics will include developing sound budgets, protocol review, IRB, FDA, and HIPAA compliance, differences among industry‐sponsored, PI‐initiated, and NIH‐funded clinical trials, and the uses of the Clinical trials.gov website. After this Webinar, attendees will be able to: 1. Identify the substantive clinical trial performance steps which must be covered in the clinical trial contract; 2. Determine the risks involved in a clinical trial; 3. Identify the scope needed for the subject injury/adverse event, indemnification, insurance, and warranty provisions.

Instructor: Stephanie C. Tramz, J.D., Contract and Grant Officer, Office of Sponsored Research Stanford University

All attendees will receive 1.5 RCR Contact Hours.

RSVP Research Integrity:  email