Essential documents comprise the documentation that must be generated and maintained to demonstrate that a clinical trial was conducted in compliance with GCP and applicable regulatory requirements. These documents serve as evidence that investigators, sponsors, and monitors conducted the trial properly, that data integrity was maintained, and that the rights and welfare of participants were protected. The complete set of essential documents must be sufficient to allow regulatory authorities to reconstruct and evaluate the trial.

ICH E6 categorizes essential documents according to the trial phase when they should be generated: before the clinical phase begins, during the clinical conduct of the trial, and after completion or termination of the trial. Pre-trial documents include the protocol, investigator qualifications, IRB/IEC approvals, and regulatory authorizations. Documents generated during the trial include signed informed consent forms, case report forms, adverse event reports, and monitoring reports. Post-trial documents include final reports, study-specific procedure manuals, and documentation of database closure.

The sponsor and investigator share responsibility for maintaining essential documents, though specific requirements differ depending on the document type. Some documents must be retained by both parties, some only by the sponsor, and some only by the investigator. Both parties must ensure that their essential documents are complete, organized, accessible for inspection, and retained for the regulatory-required period, which is typically at least two years following the last approval of a marketing application in an ICH region or until no marketing application is pending or contemplated.

Essential documents comprise the documentation that must be generated and maintained to demonstrate that a clinical trial was conducted in compliance with GCP and applicable regulatory requirements. These documents serve as evidence that investigators, sponsors, and monitors conducted the trial properly, that data integrity was maintained, and that the rights and welfare of participants were protected. The complete set of essential documents must be sufficient to allow regulatory authorities to reconstruct and evaluate the trial.

ICH E6 categorizes essential documents according to the trial phase when they should be generated: before the clinical phase begins, during the clinical conduct of the trial, and after completion or termination of the trial. Pre-trial documents include the protocol, investigator qualifications, IRB/IEC approvals, and regulatory authorizations. Documents generated during the trial include signed informed consent forms, case report forms, adverse event reports, and monitoring reports. Post-trial documents include final reports, study-specific procedure manuals, and documentation of database closure.

The sponsor and investigator share responsibility for maintaining essential documents, though specific requirements differ depending on the document type. Some documents must be retained by both parties, some only by the sponsor, and some only by the investigator. Both parties must ensure that their essential documents are complete, organized, accessible for inspection, and retained for the regulatory-required period, which is typically at least two years following the last approval of a marketing application in an ICH region or until no marketing application is pending or contemplated.