Welcome back to the Hart GCP knowledge series. Today, we will dive into the definition of essential documents found in the Good Clinical Practice (GCP) guidelines.
The guideline defines essential documents as “documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.” The guideline devotes nine pages to explaining what these documents are, when they should be collected and in what files they should be located.
These documents serve several important purposes in the conduct of a clinical trial. They demonstrate compliance of the research team, including the investigator, sponsor, monitor, and any other member of the clinical research team. They are usually the files that are audited to evaluate data integrity and valid trial conduct.
Essential documents are grouped according to when they are generated during a trial and include those documents generated prior to the start of enrollment in a trial, during the enrollment and follow-up portion of a trial, and after completion of the trial. Two sets of study files are kept: one master file kept by the sponsor, and an investigator or site file, kept onsite at each of the investigative sites. The guideline provides descriptions of each document and where it should be filed. Some documents are required to be stored at both locations.
Some examples of essential documents required to be collected prior to the start of a clinical study are:
- Investigator’s brochure
- Signed study protocol and any amendments
- IRB or ethics committee approval of protocol and informed consent document
- Financial agreements between the research site and the sponsor
- Insurance statement where required
- FDA or other regulatory agency approval to conduct the trial
For the exhaustive list of essential documents, go to the E6 guideline, here.
Thank you for reading HCC’s glossary series! Next time we’ll dive a bit more into some of these important essential documents.