Changes to the Study Plan - Amendment
Sometimes a study plan needs a correction or an addition, perhaps because it was not complete when authorised. In these circumstances a study plan amendment has to be written.
What do you understand by the term study plan amendment?
Study plan amendment means an intended change to the study plan after the study initiation date. Amendments to the study plan should be justified and approved by dated signature of the Study Director and maintained with the study plan
Because the study plan amendment becomes part of the approved study plan, all relevant parties should be told about the changes formally. Study plan amendments should be distributed to all recipients of the study plan, both study personnel and Quality Assurance personnel.
Note that a study plan deviation i.e. an unintended departure from the plan, may have consequences that require changes to be made to the future performance of the study, and so may result in a study plan amendment.
