Trial Master File

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 o o o o o o o

Updating documents in the TMF monitoring visit reports Communications (other than site visits) Signed CRF’s CRF corrections Serious adverse eventsreports and safety information Interim reports to ethics committees 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