Essential Documents
Essential Documents
Find essential documents that are used to evaluate the conduct and quality of clinical trials.
Essential Document Support we provide:
- Essential Document Templates
- Essential Document Consultations
Request support for Essential Documents by contacting the CTSI-Regulatory Team.
What are Essential Documents?
Required study related documents that are used to evaluate the conduct of a clinical trial and the quality of the data produced. These documents serve to:
- Demonstrate the compliance of an investigator, sponsor and monitor with the standards of Good Clinical Practice (GCP) and applicable regulatory requirements
- Assist with the successful management of the trial by the investigator, sponsor and monitor
- Used for auditing/inspecting by the sponsor’s auditor or regulatory inspector(s)
The term essential document is defined by the International Council for Harmonization Good Clinical Practice E6 A2 (ICH-GCP E6A2) (PDF) and a detailed list of required essential documents can be found in section eight of that guideline.
Essential documents are commonly referred to as regulatory documents. Regulatory documents may also include predicate documents, which are documents required to be maintained by Title 21 Code of Federal Regulations (21 CFR) and that the FDA requires a company to submit to them as part of compliance for FDA regulated research.
What Kind of Media should be Used for Essential Documents?
Essential documents may be electronic or paper. Some essential documents, such as source documents, may be stored as audio tapes, recordings or images.
If conducting FDA regulated human subject’s electronic essential documents should comply with 21 CFR Part 11: Electronic Records; Electronic Signatures and Part 11, Electronic Records; Electronic Signatures – Scope and Application.
Established electronic systems used for some or all essential documents by Ohio State Researchers include:
Where should Essential Documents be Stored?
Essential documents should be stored in an electronic or paper-based site master file. The site master file should be established at the beginning of the research study and maintained throughout the study. Unless otherwise noted, essential documents should also be filed with the study sponsor or Contract Research Organization (CRO) in their trial master file.
Records regarding the location of the essential documents should be maintained by the sponsor and the investigator/institution. Additionally, identification of the storage system(s) used during the trial and archival process should include information related to document identification, version history and the search and retrieval process.
If conducting an Investigator Initiated Multi-Center Trial, the Sponsor Investigator should maintain a trial master file that includes the essential documents from each participating site and should ensure these documents are maintained throughout the duration of the study.