Can a "generic protocol" be used for obtaining sponsor approval?
The GLPS require that the protocol be approved by the sponsor, and the date of approval must be included with the protocol; however the GLPS also provide flexibility in how this approval is obtained. A "generic protocol" approach may be acceptable for obtaining sponsor approval of certain protocol elements. In such a case, the testing facility which is drafting the protocol for a study would only need to obtain approval of those elements which were not included in the generic protocol. Please note that since the GLPS require protocols to include certain information that would not be included in a generic protocol, such as the test substance or the proposed start and termination dates, it would still be necessary to obtain sponsor approval for such information in addition to the approval of the generic protocol.
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