Documents are an integral part of clinical research. Essential documents are those documents which individually and collectively allow the evaluation of the conduct of a trial and the quality of the data generated. Good Clinical Practice (GCP) guidelines require that all documents and information pertaining to a clinical trial be handled, stored and recorded in such a way that it can be reported, interpreted and verified in an accurate manner.
Clinical trial documents also demonstrate the degree of compliance of the investigator(s), sponsor and monitors with applicable regulations and GCP guidelines. They are usually audited by the Sponsor and inspected by the regulatory authorities to confirm data validity and integrity. Appropriate filing of these documents at the sites and with the investigator / institution also aids the efficient management of the trial conduct.
The minimum list of essential documents can be categorized into different time points in the study as documents needed:
- Before the commencement of the clinical phase of the study
- During the clinical phase of the study
- After completion or termination of the study
Appendix V of Good Clinical Practices for Clinical Research in India and the ICH Good Clinical Practice Guidelines provides the minimum list of essential documents along with their recommended location (i.e. whether the documents are to be included in the Investigator / Sponsor / CRO files). It is recommended that one reads both these sources to ensure that the list of essential documents is complete. This template has been developed in accordance to these guidelines.
Master Files containing all documents pertaining to the trial or study, should be established at the beginning of the trial, at the Investigator’s / Institution site, Sponsor’s office, Ethics Committee’s office and at the CRO’s office (if contracted). Most (or all) documents included in the master file may be subjected to an audit by the sponsor or an inspection by the regulatory authority(ies). Therefore, it is advisable that a systematic record of their location is maintained.
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).
The following sections explain in detail some of these essential documents and provide links to useful resources where sample templates can be accessed: