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Essential Documents Needed During the Conduct of Clinical Investigations

The documents required during the lifecycle of a clinical investigation ("Essential documents") are not explicitly described in the Federal regulations governing recordkeeping and record retention (21 CFR 312.62 and 812.140).

The FDA has adopted the International Committee on Harmonisation's E6 consolidation guide for GCP definitions, Section 8, as its guidance document on this topic.

Essential documents have several important purposes:

  • To demonstrate the compliance of the investigator, sponsor, and the monitor with all applicable regulatory requirements and GCP
  • To assist in the successful management of the study by the investigator, sponsor, and monitor
  • To confirm the validity of the conduct of the clinical investigation and the integrity of the data collected.

The ICH E6 consolidation guide for GCP groups these documents into three sections according to the stage of the study during which they would normally be generated:

  • Before the clinical phase of the study commences
  • During the clinical conduct of the study
  • After completion or termination of the study.

It is acceptable to combine some of the documents, as long as the individual elements are readily identifiable.

Master study files must be established at the beginning of the study, both at the investigator's site and at the sponsor's office. A final close-out of the study can be done only after a monitor has reviewed both the investigator files and the sponsor files and confirmed that all necessary documents are in the appropriate files. All the essential documents are subject to audit by the sponsor's auditor and inspection by regulatory agencies.

Essential Documents:

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