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
This blog is written by Mr. Steven C. Schurr, Esq. This blog is will focus on: For Researchers and Businesses: Contracts, Health Care Regulatory Compliance, Privacy Rights, Formation, Employment Issues. For Health Care Providers: Contracts, Health Care Regulatory Compliance, Privacy Rights, Disciplinary Matters. For Patients: Insurance Coverage, State and Federal Disability Coverage, Patient Advocacy Issues, Privacy Issues, Mental Health Coverage and Treatment.
Thursday, August 28, 2008
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