Archiving of clinical trial Essential Documents

Essential documents assist in the successful management of a trial by the investigator, sponsor and monitor, and are audited and/or inspected by auditors/regulatory authorities when confirming the validity of the trial conduct and integrity of data collected. The investigator should therefore take measures to prevent accidental or premature destruction of these documents and ensure they are adequately archived at the end of the trial. This procedure therefore describes the process for archiving Essential Documents generated during a clinical trial.