Scribd
Upload
2K views

Trial Master File

The document discusses the importance and management of a Trial Master File (TMF) for clinical trials. The TMF contains all essential documents relating to a clinical trial, organized in a way that allows evaluation of the trial conduct and quality of collected data. It permits reconstruction of the trial and demonstrates compliance. Proper management of the TMF is important for reproducing data, attesting to data integrity, facilitating inspections, and smoothing audits. The TMF should be held by the chief investigator or coordinating center and contain essential documents before, during, and after a trial, including the protocol, ethics approvals, safety reports, and final clinical study report. Proper filing and labeling of original documents in

Uploaded by

api-3810976
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
2K views

Trial Master File

The document discusses the importance and management of a Trial Master File (TMF) for clinical trials. The TMF contains all essential documents relating to a clinical trial, organized in a way that allows evaluation of the trial conduct and quality of collected data. It permits reconstruction of the trial and demonstrates compliance. Proper management of the TMF is important for reproducing data, attesting to data integrity, facilitating inspections, and smoothing audits. The TMF should be held by the chief investigator or coordinating center and contain essential documents before, during, and after a trial, including the protocol, ethics approvals, safety reports, and final clinical study report. Proper filing and labeling of original documents in

Uploaded by

api-3810976
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 12

TRIAL MASTER FILE

DR.Jayashree
ICRI
INTRODUCTION
 TMF is the hard copy of all the documentation
relating to the clinical trial-held by the sponsor .
 Filing system of ED
 ICH –GCP guidelines on essential documents
 Documents which individually and collectively
permit the evaluation of the conduct and the
quality of the data produced
 Demonstrate compliance
 Organized way facilitate management of CT
 AUDITS AND INSPECTION
IMPORTANCE
 ED+others – reconstruct the trial
 Reproducibility of data collected
 Permanent record
IMPORTANCE
 Attest to the integrity of the data
 For inspections
 Testimony to the conduct and success of
the trial
 Easy to access and easy to follow
 Increase the team flexibility and efficiency
 Smoothing the audits and inspections
RESPONSIBILITY AND
MANAGEMENT
 CTA – Accountable, No missing documents
, complete and accurate
 Appearance :
– Easy to access and follow
– Labeling to be clear and index, systems same
– All original documents
Trial Master File
•Trial Master File should be held at the principal site
by the Chief Investigator or at the Co-ordinating
Centre
•EU guidance on Trial Master File not available yet
•Trials preparing for a licensing application: Section 8
of ICH GCP can be followed
•Documents to be contained in the Master File will
vary according to the trial
•Guidance on key documents can be found in the
MRC GCP Guidelines
Essential documents in the
trial master file

 Before the clinical phase the trial commences


 During the clinical conduct of the trial
 After completion or termination of the trial
ED -BEFORE
 IB
 PROTOCOL &PROTOCOL AMENDMENTS
 INFORMATION SHEETS
 FINANCIAL ASPECTS OF THE TRIAL
 INSURANCE STATEMENT
 SIGNED AGREEMENTS
 EC COMPOSITION AND APPROVALS
 CV
ED -BEFORE
 LABORATORY PROCEDURES AND NORMAL
VALUES
 INVESTIGATION PRODUCT
 MASTER RANDOMISATION LIST AND
DECODING PROCEDURES
 PRE TRIAL MONITORING REPORT AND TRIAL
INITIATION MONITORING REPORT
DURING THE CONDUCT
o Updating documents in the TMF
o monitoring visit reports
o Communications (other than site visits)
o Signed CRF’s
o CRF corrections
o Serious adverse eventsreports and safety
information
o Interim reports to ethics committees
o Record of the retained body fluids /tissue samples
After completion or
termination

 Audit certificate
 Final close out report
 Clinical study report
Issues
 Non compliance with ICH-GCP
 missing documents
 Wrongly dated documents

You might also like