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Investigator site file procedure

1 Background

All research carried out at Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH NHS FT) must have a study site which contains essential documents. It is intended the file be initiated immediately upon confirmation of registration of the study with the research department and maintained for the duration of the study. The research governance team can provide advice and document templates, please contact them at rdash.research-gov@nhs.net.

2 Aim

To ensure all research projects within the trust maintain an appropriate study file. This procedure has been produced in accordance with International Community of Harmonisation (ICH) or Good Clinical Practice (GCP) guidelines, UK Framework for Health and Social Care Research (2017), the Medicines for Human Use (Clinical Trials) Regulations (2004) and subsequent amendments.

3 Scope

All staff, internal or external, to the trust who take on the role of research study chief investigator (CI), principal investigators (PI) or local collaborators (LC) and any member of the research team with delegated duties to maintain master or site files.

This procedure is overarched by the research governance policy.

5 Procedure

5.1 Definition

There are two types of study file, the trial master file (TMF) or investigator site file (ISF). Both contain the essential documents necessary for the conduct of a research study. The trial master file is the main study file, maintained at the lead site (chief investigator site) and contains sponsor documents, as well as the core documents. The site investigator file contains core documents and localised documents.

Section 8 of International Community of Harmonisation or Good Clinical Practice guidance details the essential documents necessary for the conduct of a trial.

Essential documents are those which individually and collectively:

  • permit the evaluation of the conduct of a trial and the quality of the data produced
  • serve to demonstrate the compliance with the standards of good clinical practice (GCP) and with all regulatory requirements
  • when filed in an appropriate and timely manner greatly assist in the successful management of a trial by the investigator
  • can be audited by the trust, sponsor, independent auditor and inspected by regulatory authorities as part of the process to confirm the validity of the trial conduct and data collection

The chief investigator or sponsor representative will maintain a trial master file. The principal investigator will keep an SF. In the case of a single centre study there will often be a single file for both chief investigator and principal investigator, this file will be a trial master file.

5.2 Procedure

The chief investigator, principal investigator, or delegated person is responsible for setting up, maintaining, storing and arranging archiving of the trial master file or investigator site file. This duty may be delegated to another appropriately qualified member of the research team and recorded in the delegation of study duties log (see delegation of study duties procedure).

The chief investigator, principal investigator, or delegated person begins to set up the trial master file or investigator site file at the time the research is registered with the research department, before the study opens.

The chief investigator, principal investigator, or delegated person should ensure all essential documents are filed in reverse date order unless specified otherwise.

The chief investigator, principal investigator, or delegated person should carry out regular checks to ensure the contents are up-to-date, amendments have been processed and old versions of documents superseded.

The trial master file or investigator site file must be stored securely, but all members of the research team have access to the file to complete any delegated duties.

Documents should be filed promptly, ensuring that any superseded recruitment documents stored outside the trial master file or investigator site file are replaced.

Superseded documents should be struck through with a line across the first page and marked as superseded. The person updating the file must initial and date the document and file in the appropriate section.

The declaration of end of study and final study report must be filed in the trial master file or investigator site file before the file is archived.

The trial master file or investigator site file should be archived according to the requirements of the sponsor and regulatory authorities and following trust policy. Advice on research archiving is available from the research governance team.

6 Appendices

6.1 Appendix A references

6.2 Appendix B definitions of acronyms used

Acronym Long form
CI Chief investigator
GCP Good clinical practice
ISF Investigator site file
PI Principal investigator
TMF Trial master file

Document control

  • Version: 3.
  • Unique reference number: 431.
  • Approved by: research and innovation group.
  • Date approved: 9 September 2025.
  • Name of originator or author: research governance manager.
  • Name of responsible individual: chief medical officer.
  • Date Issued: 12 September 2025.
  • Review date: 30 September 2028.

Page last reviewed: September 12, 2025
Next review due: September 12, 2026

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