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Paragraph 20 Study plan

Original text. Later amendments are not shown.

(1)

For each safety study, a plan should exist in a written form prior to initiation of the study.

(2)

The study plan should be retained as raw data.

(3)

All changes, modifications, or revisions of the study plan, as agreed to by the study director, including justifications, should be documented, signed and dated by the study director, and maintained with the study plan.