The Trial Master File (TMF) is a compilation of essential documents that demonstrate compliance with study protocols and quality data management during clinical trials. It encompasses both sponsor and investigator files, necessitating segregation of documents generated by each party. Responsibilities for TMF maintenance and management are often delegated to research team members or subcontracted to Clinical Research Organizations (CROs), ensuring adherence to guidelines and standard operating procedures.

1. T
M
F
Trial
Master
File

2. DEFENITION :
Compilation of documents
To demonstrate that
has conducted in
accordance with

3. Quality of data (during trial) Safe conduct of the trial Monitor, Audit, Inspector,
and others to evaluate
compliance with the study
protocol
Allows

4. maintain
Master file
at
Sponsor
Local site
Should be at being of the trial
and need to be continued
throughout the trial

5. Based on
Paper Electronic
Normally
composed of
Sponsor TMF (held by the sponsor organization)
Investigator TMF (held by the investigator
also referred to as the ISF/regulatory binder)

6. During the preparation of TMF, it is important
to segregate the documents that are generated
and held by the sponsor from the investigator
Such as :
Investigator: Subject identification code list
Sponsor: Master randomization list

7. 1.Standardized processes
2.Document list/table of
contents
3.Metrics and controls
4.TMF organization/ resources
5.eTMF

8. ICH has published a minimum required set of essential documents for
TMF
Minimum essential documents for human clinical trials can be
grounded in ICH’s good clinical practice
Example: Signed protocol
Audit certificate
Subject enrolment form

9. Responsibility for updating, maintaining, and reviewing
the TMF should be delegated to one of the members of
the research team.
TMF management is subcontracted to CRO

10. Responsibilities :
Overall management and quality maintenance of essential clinical
trials and other documents including the setup and maintenance of
TMF with a focus on ensuring that routine document management
operations are performed with adherence to SOPs and GCP/TMF
guidelines
Paper and eTMF system management by filing organizing and
maintaining activities performed by 3 parties such as clinical sites
and other internal and external teams members as required

11. References :
1. https://novotech-cro.com/faq/what-trial-master-file-
tmf#:~:text=A%20Trial%20Master%20File%20(TMF,the%20Investigator%2C
%20Sponsor%20and%20Institution.
2. https://lmkclinicalresearch.com/blogs/5-pillars-of-the-trial-master-file-
tmf/
3. https://cdsatoolkit.thsti.in/trial-master-file-tmf/
4. https://en.wikipedia.org/wiki/Trial_master_file

12. M. SONY-006/0122
sonyvarma2801@gmail.com