Paragraph 1 Study plan

(1)

For each regulatory study, a written plan should exist prior to initiation of the study. The study plan should be approved by dated signature of the study director and verified for good laboratory practice compliance by quality assurance personnel as specified in paragraph 2(b) of Part II of this Schedule.

(2)

As respects the study plan—

(a)

amendments to it should be justified and approved by dated signature of the study director and maintained with the study plan;

(b)

deviations from it should be described, explained, acknowledged and dated in a timely fashion by the study director and/or any principal investigators and maintained with the study raw data.

(3)

For short-term studies, a general study plan accompanied by a study specific supplement may be used.

Notes on Schedule 1

Textual amendments

F1: Words in Sch. 1 heading substituted (27.4.2004) by The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(d)