Changes to the Study Plan - Study Director Replacement
During the course of a study it may become necessary to replace the Study Director. In these circumstances management will need to designate an appropriately qualified, trained and experienced person to take over.
Replacement of a Study Director should be done according to established procedures and should be documented.
Since this is an intended change to the study plan what do you think is required? Click here to find out
Replacing the Study Director requires:
- A study plan amendment.
- The master schedule should also be updated.
The replacement Study Director will now be responsible for the overall conduct of the study and for its final report.
