Contents
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. A template sile file contents page (appendix A) can be accessed via the RDaSH NHS FT intranet, or on request to the research office at rdash.groundedresearch@nhs.net.
2 Aim
To ensure all Research Projects within the trust maintain an appropriate Study File. This SOP 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.
4 Link to overarching policy, and or procedure
5 Procedure or implementation
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 TMF is the main study file, maintained at the lead site (chief investigator (CI) site) and contains sponsor documents, as well as the core documents. The site investigator file contains core documents and local documents such as the delegation log (see appendix A).
Section 8 of ICH or GCP 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 CI will keep a trial master file. The PILC will keep an TMF or ISF. In the case of a single centre study there will often be a single file for both CI and PI. In this case this file will be a trial master file.
5.2 Procedure
The CI, PI, or LC is responsible for setting up, maintaining, storing and arranging archiving of the TMF or ISF. 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 SOP).
The CI, CI, PI, or LC begins to set up the TMF or ISF at the time the research is registered with the research department, before the study opens.
The CI, CI, PI, or LC should ensure all essential documents (see appendix A) are filed in reverse date order unless specified otherwise.
The CI, PI, or LC should carry out regular checks to ensure the contents are up to date, amendments have been processed and old versions of documents superseded. CI, PI, or LC.
The TMF or ISF must be stored securely but ensure 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 of the TMF or ISF are replaced.
Superseded documents should be struck through with a line across the first page and marked as superseded. The person updating the site file must initial and date the document and file in the appropriate section of the site file.
The annua reports, declaration of end of study and final study report must be filed in the TMF or ISF before the file is archived.
The TMF or ISF should be archived according to the requirements of the sponsor and regulatory authorities and following RDaSH NHS FT policy
6 Appendices
6.1 Appendix A Investigator site file
Document control
- Version: 2.1.
- Unique reference number: 431.
- Approved by: Corporate policy approval group.
- Date approved: 29 January 2024.
- Name of originator or author: Research governance manager.
- Name of responsible individual: Research panel
- Date Issued: 12 February 2024.
- Review date: December 2024.
- Target audience: All staff involved in research.
Page last reviewed: March 11, 2024
Next review due: March 11, 2025