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I am an investigator developing a protocol for a gene transfer clinical trial. What are the first things I need to do to prepare for a review of my trial by the RAC?

April 26, 2017clinical trial developing gene investigator prepare Protocol review transfer trial

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I am an investigator developing a protocol for a gene transfer clinical trial. What are the first things I need to do to prepare for a review of my trial by the RAC?

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First, you should read Appendix M of the NIH Guidelines, which outlines points to consider in the design and conduct of these trials. It also includes details about submitting your protocol for review by the RAC.