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Re: sts66 post# 29109

Tuesday, 06/10/2014 2:37:38 PM

Tuesday, June 10, 2014 2:37:38 PM

Post# of 448110
Actually, even the sponsor should not do this unless totally necessary. The FDA is a bit anal about the sponsor taking a peak!

7.2. Accessing Interim Data

As discussed above, accessing interim data by the sponsor carries many risks, not all of which may be fully appreciated by the sponsor. We recommend that sponsors contact FDA before initiating communication with the DMC regarding access to interim data from a trial likely to be an important part of a regulatory submission.

While FDA permission is not required, a discussion regarding the potential risks and implications of that action and of methods to limit the risks may contribute to informed decision making.
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