OpenLegislation

Division 2

United Kingdom

Original text. Later amendments are not shown.

  1. (a)

    Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.

  2. (b)

    Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.