Inspection Conduct
Study Audit
A study audit is defined as:
A comparison of raw data and associated records with the interim or final report in order to:
- Determine whether the raw data have been accurately reported
- Determine whether testing was carried out in accordance with the study plan and Standard Operating Procedures
- Obtain additional information not provided in the report
- Establish whether practices were employed in the development of data that would affect their validity
The guidance makes it clear that Inspectors should not concern themselves with the scientific design of the study or interpretation of the results of studies.
These aspects are the responsibility of those regulatory authorities to which the data are submitted for regulatory purposes.
