I will be attending a round table at the MEDI medical device conference at the Marriott in Hartford, CT on September 9, 2008. I was asked to review what I consider to be the 10 most important documents for the conduct of a successful investigational medical device clinical trial.
My topics will include the clinical trial agreement, investigator agreement/FDA form 1572, indemnification, reimbursement for adverse events, the informed consent form, delegation of responsibilities, etc. The presentation will be useful to clinical monitors, sponsor and site management, and clinical trial vendors.
For more information, go to MEDI2008.com.
Thanks!
Steve
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