TRIAL MASTER FILETRIAL MASTER FILE

DR.Jayashree

ICRI

INTRODUCTIONINTRODUCTION 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

IMPORTANCEIMPORTANCE

ED+others – reconstruct the trialReproducibility of data collectedPermanent record

IMPORTANCEIMPORTANCE

Attest to the integrity of the data For inspections Testimony to the conduct and success of

the trialEasy to access and easy to followIncrease the team flexibility and efficiency Smoothing the audits and inspections

RESPONSIBILITY AND RESPONSIBILITY AND MANAGEMENTMANAGEMENT

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 Essential documents in the trial master filetrial master file

Before the clinical phase the trial commencesDuring the clinical conduct of the trialAfter completion or termination of the trial

ED -BEFOREED -BEFORE

IB PROTOCOL &PROTOCOL AMENDMENTS INFORMATION SHEETS FINANCIAL ASPECTS OF THE TRIAL INSURANCE STATEMENT SIGNED AGREEMENTS EC COMPOSITION AND APPROVALS CV

ED -BEFOREED -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 CONDUCTDURING THE CONDUCT

o Updating documents in the TMFo monitoring visit reportso Communications (other than site visits)o Signed CRF’so CRF correctionso Serious adverse eventsreports and safety

informationo Interim reports to ethics committeeso Record of the retained body fluids /tissue samples

After completion or After completion or terminationtermination

Audit certificate Final close out reportClinical study report

IssuesIssues

Non compliance with ICH-GCPmissing documentsWrongly dated documents