The OECD Principles of Good Laboratory Practice (GLP) provide provisions for errors in the final report to be corrected and admissions to be addressed by issuing a study report amendment. However, it would not be appropriate to use a study report amendment to facilitate the reanalysis of data or add new data to a final report except under exceptional circumstances. Exceptional circumstances will include requests from receiving authorities to reopen a GLP study. Such requests are usually made so that data can be reanalysed. For example, studies may be reopened to reassess statistical analyses or to review histology findings. Monitoring authorities will usually not allow a study to be reopened if the test facility or study sponsor wants to reanalyse or add data. However, most monitoring authorities will assess each request to reopen a study on a case-by-case basis.
If a GLP study is reopened, any changes to the original text or the addition of new text must be presented in the form of a report amendment. All the original data must be retained in the final report and the reason for reopening the study should be documented in the amendment. If additional work is performed that was not required in the original study plan, it should be covered by a study plan amendment. As detailed in Section 9, Part 9.1 (5) of The OECD Principles of GLP, reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.
