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Trial Master File

The trial master file (TMF) contains all documentation related to a clinical trial held by the sponsor. It allows reconstruction of the trial and demonstrates compliance with regulations. The TMF contents are organized to facilitate trial management, audits, and inspections. It includes essential documents before, during, and after a trial such as the investigational brochure, protocol, safety reports, and monitoring records. Proper management of the TMF is the responsibility of the clinical trial administrator to ensure documents are complete, accurate, and easy to access. Issues that can arise include non-compliance with guidelines or missing/incorrectly dated documents.

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2K views2 pages

Trial Master File

The trial master file (TMF) contains all documentation related to a clinical trial held by the sponsor. It allows reconstruction of the trial and demonstrates compliance with regulations. The TMF contents are organized to facilitate trial management, audits, and inspections. It includes essential documents before, during, and after a trial such as the investigational brochure, protocol, safety reports, and monitoring records. Proper management of the TMF is the responsibility of the clinical trial administrator to ensure documents are complete, accurate, and easy to access. Issues that can arise include non-compliance with guidelines or missing/incorrectly dated documents.

Uploaded by

api-3810976
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as RTF, PDF, TXT or read online on Scribd
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trial master file

dr.jayashree
icri
introduction
l tmf is the hard copy of all the documentation relating to the clinical trial-held by
the sponsor .
l filing system of ed
l ich –gcp guidelines on essential documents
l documents which individually and collectively permit the evaluation of the
conduct and the quality of the data produced
l demonstrate compliance
l organized way facilitate management of ct
l audits and inspection
importance
l ed+others – reconstruct the trial
l reproducibility of data collected
l permanent record

importance
l attest to the integrity of the data
l for inspections
l testimony to the conduct and success of the trial
l easy to access and easy to follow
l increase the team flexibility and efficiency
l smoothing the audits and inspections
responsibility and management
l cta – accountable, no missing documents , complete and accurate
l 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 before the clinical phase the trial commences
l during the clinical conduct of the trial
l after completion or termination of the trial
ed -before
l ib
l protocol &protocol amendments
l information sheets
l financial aspects of the trial
l insurance statement
l signed agreements
l ec composition and approvals
l cv
ed -before
l laboratory procedures and normal values
l investigation product
l master randomisation list and decoding procedures
l pre trial monitoring report and trial initiation monitoring report
during the conduct
l updating documents in the tmf
l monitoring visit reports
l communications (other than site visits)
l signed crf’s
l crf corrections
l serious adverse eventsreports and safety information
l interim reports to ethics committees
l record of the retained body fluids /tissue samples
after completion or termination
l audit certificate
l final close out report
l clinical study report
issues
l non compliance with ich-gcp
l missing documents
l wrongly dated documents

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