Are sponsors allowed access to IRB written procedures, minutes and membership rosters?
The FDA regulations do not require public or sponsor access to IRB records. However, FDA does not prohibit the sponsor from requesting IRB records. The IRB and the institution may establish a policy on whether minutes or a pertinent portion of the minutes are provided to sponsors. Because of variability, each IRB also needs to be aware of State and local laws regarding access to IRB records.
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