Quality Assurance Personnel
We saw in Module 02 that there are Quality Assurance Personnel independent of the study. Their responsibilities include:
- Maintaining copies of all approved study plans and Standard Operating Procedures in use in the test facility
- Having access to the master schedule
- Conducting inspections to determine if all studies are conducted in accordance with the Principles of Good Laboratory Practice
- Promptly reporting any inspection results in writing to management, and to the Study Director when applicable
- Retaining records of such inspections
More about the Quality Assurance Personnel activities during the study can be found in Modules 06 and 07 of this course.
