Trial Master File

trial master file dr.jayashree icri

introduction

l tmf is the hard copy of all the documentation relating to the clinical trial-held by l l l l l l

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

l l l

ed+others – reconstruct the trial reproducibility of data collected permanent record

importance

l l l l l l

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

l l

cta – accountable, no missing documents , complete and accurate appearance : l easy to access and follow l labeling to be clear and index, systems same l all original documents

essential documents in the trial master file

l l

before the clinical phase the trial commences during the clinical conduct of the trial

l

after completion or termination of the trial

ed -before

l l l l l l l l

ib protocol &protocol amendments information sheets financial aspects of the trial insurance statement signed agreements ec composition and approvals cv

ed -before l l l l

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

l l l l l l l l

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

l l l

audit certificate final close out report clinical study report

issues

l l l

non compliance with ich-gcp missing documents wrongly dated documents