Page Comparison

TMF Folder Structure Sample

Here are common folder and/or file examples applicable in a trial master file. Keep in mind that folders can be easily copied. If you go to the work if creating a structure for one study like you see below, it could easily be copied for subsequent studies.

• Study Materials

  • Recruitment

  • Surveys

  • Instructions for use Use (IFUs)

  • Product Labeling

• Protocols

  • Final signed copiesSigned Copies

  • Amendments

  • Change summariesSummaries

• Training documents

  • Site Training Materials

  • Sponsor Training Material

  • HSR Training certsCerts

• Monitoring

  • Monitoring planPlan

  • Site Initiation lettersLetters/reportsReports

  • Site Activation lettersLetters

  • Visit reportsReports

  • Site closeClose-out lettersLetters

• Data Management

  • DM Plans

  • CRFs

  • Completion guidelinesGuidelines

  • Master randomization list

• Protocol Deviations

  • PD Reports

  • IRB application submitted for PD

• Safety Management

  • Safety management planManagement Plan

  • AE reports

  • IRB application submitted for AE

• Regulatory Authority Authorizations

  • IDE approval letter

  • Audit certsCerts

  • ClinicalTrials.gov registration

• Project Management

  • Timelines

  • Invoices

  • Meeting minutes

• Notes to File

  • NTFs

  • Letters and emails

  • Meeting notes

  • Telephone calls

• Vendor Management

  • CRO contracts

  • Project Plans

  • Correspondence

  • Meeting minutes

• IRB

  • Submissions

  • Approvals

  • Roster

  • Correspondence

• Study Agreements

  • CTA and SOWs

  • Investigator AgreeementAgreement

  • Study Insurance

• Site Management

  • Contact List

  • Delegation of Authority (DOA)

  • Site Documents

  • Study staff qualifications

• Informed Consent Documents

  • IRB approved copiesApproved Copies

  • ICF checklistsChecklists

  • Amendments

• Inventory Management

  • Shipping Records

  • Device Accountability Logs

• Country Master Files