Trial Master File SOP - Liverpool School of Tropical Medicine

FINAL
STANDARD OPERATING PROCEDURE:
TRIAL MASTER FILE
Policy number CTS SOP 003 Effective Date: 01.11.10
Version number: 1.0 Approved by: S Roberts
Superseded Version Number & Date: Review Date: 01.11.11
Originator N Strickland Status: Final
1.0 BACKGROUND
Trials involve a large amount of documents for which a standard system of filing is required.
Documentation for each study should be contained within a Trial Master File (TMF) which should be
set up at the beginning of a trial. It should be held at the Co-ordinating centre of the trial and copies
of relevant documents should be kept at participating sites in a Study Site File (SSF),
ICH Good Clinical Practice guidelines define the study documents to be filed as “those documents
which individually and collectively permit evaluation of the conduct of a trial and the quality of the
data produced”. Whilst demonstrating compliance with ICH Good Clinical Practice, the filing of study
documents in an orderly, timely manner also greatly assists the smooth running of the study and any
future audit or inspection.
2.0 PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to outline the standard procedures to be
followed when creating a Trial Master File in clinical research sponsored by the LSTM. The use of this
SOP will result in a standardised method for collating and maintaining relevant documentation.
This SOP refers to the current minimum standard of documentation required in the Trial Master File,
as outlined in ICH GCP; Section 8.2, 8.3 and 8.4.
3.0 RESPONSIBLE PERSONNEL
The Principal Investigator and/or other designee(s) as documented in the Trial Responsibility Log
must ensure that the trial master file is established and properly maintained at the co-ordinating
centre.
Study sites will hold a Study Site File for the trial and the procedures for setting up and maintaining
this is described in a separate SOP.
4.0 PROCEDURE
A trial master file should be prepared as soon as possible after the first contact by the Sponsor or
for trials where there is no external sponsor, as soon as an outline protocol is available. The file
should be actively maintained and updated from this time until the trial is formally closed. When
it becomes available, the final report should be filed in the trial master file.
CTS SOP 003: Trial Master File Page 1 of 2
Version: 1.0
Status: FINAL
Release date: 01/11/10

FINAL
A dedicated member of staff should be responsible for maintaining and updating the essential
documents within the TMF from the start until the project is formally closed. This should be the
Chief Investigator, or his or her designate.
The Trial Master File (TMF) will contain original documents and confidential data. It should be
located in a secure (locked) designated area with limited access at the Trial Co-ordination Centre.
A template for the setting out of the TMF is available in the Clinical Trial Support Package.
The TMF should be divided into sections, numbered according to Template TMF.
At the start of each section, a checklist of each document contained therein should be
maintained. Within each section, each document added to the File should include a note of the
date it was added, in the top right hand corner of the front sheet of the copy.
As documents may need to be amended during a project, it is important that amendment
chronologies are kept, indicating changes and the dates they are implemented. Old documents
must be retained in the TMF alongside the new amended version(s). Please remember that any
substantial amendments to documents, such as the protocol or informed consent forms, should
be approved by the relevant authorities (the research Sponsor, RECs, Regulatory body etc.), as
appropriate, prior to implementing any changes to the project/trial.
When the trial is formally closed, the TMF should be archived in accordance with LSTMs Policy on
The Archiving of Essential Documents Generated during Clinical Research.
5.0 RELATED DOCUMENTS
LSTM CTS TF 005: Trial Master File
LSTM Policy: The Archiving of Essential Documents Generated during Clinical Research.
6.0 REFERENCES
International Conference of Harmonisation Good Clinical Practice (ICH GCP) 1996
Clinical Trials Toolkit (2009)
7.0 FURTHER INFORMATION
Please contact the Research Office for further support and guidance.
CTS SOP 003: Trial Master File Page 2 of 2
Version: 1.0
Status: FINAL
Release date: 01/11/10