Study Documentation

The investigator must ensure that the ‘Investigator Site File’ (ISF) (officially the ‘Investigator Trial Master File (TMF)’) is safely archived in such a way that the documents and data can be found and read at a later time if questions come up or an inspection by the competent authorities takes place.

Systems must be in place to ensure the safe long-term storage of essential documents:

• At investigator sites, and
• by, or on behalf of, the sponsor.
  

Different EU directives/regulations as well as international guidance documents give different retention periods for trial related documentation.