European Directive 2003/63/EC describes the minimum retention periods for trial records. However, the wording is quite ambiguous and has been interpreted differently by different organisations. It states:

Marketing authorisation holders must arrange for essential clinical trial documents (including case report forms) other than subject?s medical files, to be kept by the owners of the data:

? for at least 15 years after completion or discontinuation of the trial,
? or for at least two years after the granting of the last marketing authorisation in the European Community and when there are no pending or contemplated marketing applications in the European Community,
? or for at least two years after formal discontinuation of clinical development of the investigational product.

The document then goes on to say:

The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised. This documentation shall include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator?s brochure; case report forms on each trial subject; final report; audit certificate(s), if available.

It is not clear why core essential records need to be retained for 15 years or approval/discontinuation plus 2 years whereas all other records pertaining to the trial need to be kept for as long as the product is marketed. One interpretation is that the first (shorter) requirement applies to the investigator site file only, since the text mentions the exclusion of subject medical files, while the 2nd requirement applies solely to the sponsor records. Is this the common interpretation of these requirements? If not, how do you account for the apparent mis-match between these two retention requirements? If indeed ALL trial records need to be retained for the lifetime of the product, the first set of requirements becomes redundant.