trial master file

dr.jayashree icri

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

introduction

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

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

importance

l l 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 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

importance

responsibility and management

l l

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

essential documents in the trial master file

l l l l l l l l l l l l l l l l l l l l l l l l l l l

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

ed -before

ed -before
laboratory procedures and normal values investigation product master randomisation list and decoding procedures pre trial monitoring report and trial initiation monitoring report

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

during the conduct

audit certificate final close out report clinical study report

after completion or termination issues

non compliance with ich-gcp missing documents wrongly dated documents