Bioequivalence and Bioavailability Forum • dates in study plan of bioanalytical study

Ken Peh
★

Malaysia,
2013-03-16 14:44
(4848 d 20:33 ago)

Posting: # 10205
Views: 6,830

dates in study plan of bioanalytical study [Bioanalytics]

Dear All,

After bioanalytical method development and method validation, we will proceed to prepare study plan. According to OECD GLP principles, study plan must have the four dates as below:-

Proposed Starting Date:
Proposed Completion Date:
Study Initiation Date:
Study Completion Date:

We can provide the proposed starting date and proposed completion date. However, we can only provide the study initiation date when we actually start the assay and provide the study completion date when we complete the work.

My question is can we write on the existing study plan the date of study initiation date and study completion date ? Or we have to prepare a new page of study plan with all the four dates and attach with the existing study plan ?

What is the right way to do it ? Please advise. Thank you.

Regards,
Ken

Ohlbe
★★★

France,
2013-03-17 02:10
(4848 d 09:07 ago)

@ Ken Peh
Posting: # 10209
Views: 5,737

dates in study plan of bioanalytical study

Post reply

Dear Ken,

❝ According to OECD GLP principles, study plan must have the four dates as below:.

❝ I. Proposed Starting Date:

❝ II. Proposed Completion Date:

❝ III. Study Initiation Date:

❝ IV. Study Completion Date:

OK for (I) and (II) (OECD GLP, section II, § 8.2.3.b: The proposed experimental starting and completion dates).

According to OECD GLP section I, § 2.3.11, Study initiation date means the date the Study Director signs the study plan. So the study director will automatically write (III) when he signs the study plan. No problem.

But where did you see (IV) required in the study plan ? According to OECD GLP section I, § 2.3.12, Study completion date means the date the Study Director signs the final report. How could it be planned in advance in the study plan ?

Regards
Ohlbe

—
Regards
Ohlbe

Ken Peh ★ Malaysia, 2013-03-18 18:23 (4846 d 16:54 ago) @ Ohlbe Posting: # 10226 Views: 5,259	dates in study plan of bioanalytical study Post reply
	Dear Ohlbe, Thank you for your comments. Do you mean 3 dates are sufficient ? We have been asked by the inspector to add the Study Completion Date in the Study Plan. This puzzles us. We manually fill in the date the Study Director signs the final report, on the Study Plan. Regards, Ken

Ohlbe
★★★

France,
2013-03-18 19:35
(4846 d 15:42 ago)

@ Ken Peh
Posting: # 10228
Views: 5,374

dates in study plan of bioanalytical study

Post reply

Dear Ken,

❝ Do you mean 3 dates are sufficient ?

According to OECD GLP, yes.

❝ We have been asked by the inspector to add the Study Completion Date in the Study Plan.

Again if you stick to the definition of the study completion date, it is just not possible to have it in the study plan. May be you can try and discuss with the inspector ?

❝ We manually fill in the date the Study Director signs the final report, on the Study Plan.

I really don't see the added value of writing anything in the study plan once the study is completed... I'd be interested in hearing the justification the inspector gives, if you get one.

Regards
Ohlbe

—
Regards
Ohlbe

Ken Peh ★ Malaysia, 2013-03-20 17:45 (4844 d 17:32 ago) @ Ohlbe Posting: # 10247 Views: 5,392	dates in study plan of bioanalytical study Post reply
	Dear Ohlbe, Noted. Thank you very much. Ken