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Replies to post #169107 on Anavex Life Sciences Corp (AVXL)
IRBs involved in multi-site studies may find it difficult to conduct a thorough review with data solely from the site(s) under their purview and may need to obtain study-wide information. Sponsors are in the unique position of having information for the entire study6 and may provide it to investigators, who in turn provide it to the IRBs. FDA’s regulations do not prohibit sponsors from providing study-wide information directly to IRBs.7
FDA encourages efforts by investigators and sponsors to ensure that IRBs receive meaningful study-wide information, particularly when doing so may assist IRBs in reviewing the studies and protecting subjects.
One way to enable a useful continuing review of multi-site studies while reducing or eliminating duplication of effort is through the use of cooperative review greements or other mechanisms (e.g., using a centralized IRB review process), in accordance with 21 CFR 56.114. Cooperative agreements may vary with respect to how continuing review will be carried out. For example, some agreements may designate a specific IRB as having primary responsibility for continuing review of an investigation.8 Other agreements may assign responsibility for local issues to the institution’s IRB, but assign the remaining aspects of continuing review to a central IRB.
Whatever the arrangement, the IRB(s) responsible for continuing review of multi-site studies may find it helpful to obtain and review information across the entire study. For additional discussion, see Section III.B. of this guidance.
