There is a good deal of confusion on these dates and proper interpretation impacts on
several GLP areas. Accordingly, the following clarification is offered: At the time of
protocol development, the study director is to propose to management the approximate time
frame of the study. Section 58.120(a)(4), therefore, requires that the protocol contain the
proposed starting and completion date of the study. These dates are somewhat
discretionary provided that they are identified in the protocol. Suitable identification can
be the date of first dosing of the test system to the date of last dosing, the date of allocation
of the test system to the experimental units to the date of necropsy of the last animal on test,
the date of receipt of the test system to the date of final histopathological examination, or
any combination of these or any other logical starting and completion dates. After this, the
protocol is signed by the study director and forwarded for approval to management.
Management approves, if indicated, signs and dates and at this point the study becomes a
regulated study and must be entered on the Master Schedule Sheet. The study is carried on
the Master Schedule Sheet until the study director submits a signed and dated final report.
Thus, for Master Schedule Sheet purposes, the starting date of the study is the date of
protocol approval by management and the completion date of the study is the date of
signature of the final report by the study director. Neither of the foregoing timeframes need
be used to define the study terms described in section 58.35(b)(3) and section 58.105(d). For
these sections, the traditional terms found in the toxicology literature may be used.
