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