5. Essential Documents

According to the ICH Guideline, Section 1.23, ‘essential documents’ are defined as:

‘Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced’.

The GCP Guideline gives under section 8 (Essential documents for the conduct of a clinical trial) a minimum list of all documents that need to be generated, filed and archived by the investigator and by the sponsor. Some of these documents need to be filed in both places like the protocol or the Investigator’s Brochure (IB). Some other documents are only to be filed by one party, for example:

The investigator files:
  • The participant identification code list to document that investigator/institution keeps a confidential list of names of all participants allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any participant.
  • The signed Informed Consent documentation.
  • Advertisement for participants recruitment (if used) to document that recruitment measures are appropriate and not coercive.
The sponsor files:
  • Documents concerning the label(s) attached to investigational medicinal product container(s) to document compliance with applicable labelling regulations and appropriateness of instructions provided to the participants.
  • Samples of the labels.