Essential documents

It is a legal requirement for sponsors and investigators to maintain essential documentation. This chapter outlines the ICH GCP E6 requirements for documentation before, during and after the study. It describes each document and its purpose in the study. The chapter also describes how to deal with additional documentation kept by sponsors and sites but not addressed in the guidelines e.g. correspondence, emails and notes to file, The organisation of the trial master file (TMF) is not defined in guidelines but many companies and institutions will have a filing system described in SOPs, most are numeric and an example content list is given. The TMF must be maintained and stored correctly and version control of documentation is vital to maintain the audit trail. The legislation does not distinguish between commercial and non-commercial/academic studies but researchers are expected to adhere to the principles of GCP and maintain the TMF requirements. Originally TMF were paper based but the eTMF is now widely used by commercial sponsors. The retention time for the TMF has changed on a number of occasions the EU Regulation clearly states that essential documentation must be kept for 25 years and must be readily available for inspection.