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Protocol version

Item 3: Date and version identifier.


Issue Date: 25 Jul 2005
Protocol Amendment Number: 05
Author(s): M.D.; J.H.

Revision Chronology:

. . . 2004-Jan-30: Original
. . . 2004-Feb-7: Amendment 01.: Primary reason for amendment:
Changes in Section 7.1 regarding composition of comparator placebo
Additional changes (these changes in and of themselves would not justify a protocol amendment):
Correction of typographical error in Section 3.3 . . .
. . .
. . . 2005-Jul-25: Amendment No.5: At the request of US FDA [United States Food and Drug Administration] statements were added to the protocol to better clarify and define the algorithm for determining clinical or microbiological failures prior to the follow-up visit.”33


Sequentially labelling and dating each protocol version helps to mitigate potential confusion over which document is the most recent. Explicitly listing the changes made relative to the previous protocol version is also important (see Item 25). Transparent tracking of versions and amendments facilitates trial conduct, review, and oversight.

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