RQA GLP Committee
It would be up to the Study Director to document what was missing and record the impact to the study. If this impact was sufficient to call in to question the compliance of the study, then it should be documented in the GLP Compliance statement.
Can you reconstruct the activities from other data? If, for example one necropsy form was missing from a 500 animal study and you had other information – in-life findings, tissues, histology forms etc then the study may not be considered to be impacted and would be compliant. However, if the purpose of the study was storage stability at a particular temperature and you didn’t have anything to confirm that temperature had been maintained then you wouldn’t have met the objectives of the study, and any conclusions may be unreliable. Ultimately the responsibility rests with the study director and any omissions, deviations and potential justifications should be assessed, and if data has gone missing then the circumstances should be investigated, and a CAPA initiated.