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Chief Investigator
Trial Master File INDEX
Please note the ticks in the columns below indicate that the documents should be filed in the respective files.
Index may vary according to trial specifics.
TABLE OF CONTENT
Insert Date
when Filed.
Insert NA, if
Not Applicable
CI TMF Index
1.0 UCL SPONSORSHIP
First Contact Questionnaire
Sponsorship Letter (s)-In principle/Final
Legal Representative Letter of Engagement (if applicable)
Insurance Registration Form
Insurance/Indemnity Letter
Peer Review (if applicable)
2.0 FUNDING AND AGREEMENTS
IMP
IMP Supply Agreement
Technical Agreements (i.e. manufacturing/QP release, packaging, radiolabelling, IMP
importation)
Other
Central Services
Central Laboratory Services Agreement/ Material Transfer Agreement if not with the
CTSA (if applicable)
CRO Agreement / Service Level Agreement (if applicable)
Randomisation / Code break agreements (if applicable)
Other
Funding
Funding – Grant Application
Funding – Grant Award
Funding agreement
Other
Responsibility Assignments (note CTSAs maintained in section 18)
Sponsor-CI Agreement
Legal Representative-Sponsor Agreement
Other
Miscellaneous
Confidentiality agreements
Other
3.0 Research Ethics Committee (REC) (please file in chronological order and clearly label
each submission separately)
Initial signed application and supporting documentation to REC (including cover letter,
REC validation letter, favourable/ provisional/with conditions letter / response to
conditions of approval)
Substantial and Non Substantial Amendment s (including, Signed Annex 2,
Supporting Documents, cover letter, favourable opinion letter /with conditions,
response to conditions of approval- where applicable )
Annual Progress Report to REC and acknowledgement
Serious Breach notifications
End of Trial Notification to REC and MHRA
Final Report Notification and Supporting Documents
Other
4.0 Medicines and Healthcare Regulatory Agency (please file in chronological order and
clearly label each submission separately)
Initial signed application and supporting documentation to MHRA (including cover
letter, validation letter, acceptance/with conditions/grounds for non-acceptance letter
/response to conditions of approval/non acceptance)
Serious Breach notifications
End of Trial Notification to MHRA
Final Report Notification and Supporting Documents
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Other
5.0 Amendments- (please file in chronological order and clearly label each submission
separately) Please log all amendments specific to the study here. This includes MHRA or
REC or R&D
Insert Date
when Filed.
Insert NA, if not
applicable
Log of Amendment(s) (non-substantial and substantial)
Substantial and Non Substantial Amendment s (including, Signed Annex 2,
Supporting Documents, cover letter, favourable opinion letter /with conditions,
response to conditions of approval- where applicable )
Other
6.0 PROTOCOL
Current Approved Protocol & Signature Page
Superseded versions and Signature Pages
Protocol Development Documentation
7.0 PATIENT/SUBJECT INFORMATION (sites to hold relevant documents on letter headed
paper)
Sponsor Review/Approval of following documents:
Template Patient/ Information Sheet and Consent Form (PIS)/ ICF
Template GP Letter
Other
Current Approved Template Patient/ Information Sheet and Consent Form (PIS)/ICF,
GP letter
Superseded versions of Template Patient/ Information Sheet and Consent Form
(PIS)/ICF, GP letter
Template Quality of Life Questionnaires (validated NHS or trial specific if applicable)
Superseded versions of Template Quality of Life Questionnaires (validated NHS or trial
specific if applicable)
Template Patient Diaries (if applicable)
Superseded versions of patient diaries
Original Signed Informed Consent Forms (per patient/donor)
Other
8.0 CLINICAL TRIAL IMP Documentation
Note maybe located in separate pharmacy/IMP file
Summary of drug arrangements
Current Product Information (Full/Simplified IMPD)
Current IMP Safety Information document (IB or SPC)
Superseded version of Product Information
Superseded version of IMP Safety Information document (IB or SPC)
Sample of Approved Label
MA (IMP) Licence (if applicable)
Certified QP Release Statement (if applicable)
QP declaration (if applicable)
IMP Certificate of Analysis (if applicable)
TSE Certificate (if applicable)
Master Randomisation List (if applicable)
IMP Prescription Template
IMP Accountability Log Template (if applicable)
IMP Destruction Log Template (if applicable)
Temperature Log Template (if applicable)
Temperature Deviation Log (if applicable)
IMP Recalls
Other
9.0 DATA MANAGEMENT
UCL Data Protection Application Form
UCL Data Protection Registration Confirmation
Current Approved CRF
Superseded versions of CRFs
CRF Review/ approval checklist signed by CI and statistician
Data management plan/SOP
Database validation documentation (if applicable)
Data Query documentation (if applicable)
Completed CRFs, Diary Cards and Quality of Life Questionnaires
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Other
10.0 STATISTICS
Insert Date
when Filed.
Insert NA, if not
applicable
Statistician letter of engagement
Statistical Review
Statistical Analysis Plan (if applicable)
Interim Data Analysis
Final Data analysis
Other
11.0 TRIAL OVERSIGHT COMMITTEES (if applicable)
Trial Management Group (TMG) Reports/Minutes
Data Monitoring Committee/Independent Data Monitoring Committee (DMC)/(IDMC)
reports/minutes
Trial Steering Committee (TSC) reports/minutes
Terms of Reference/Charters for above Committees (if applicable)
Other
12.0 PUBLICATIONS
Current Results + Related publications
Other
13.0 PHARMACOVIGILANCE
Serious/Adverse Events Log (N.B. for Phase I trials all AEs should be recorded in
the log)
Sample SAE form and pregnancy form
JRO SOP for the Recording and Reporting of (Protocol and GCP) deviations,
violations, serious breaches and urgent safety measures
Completed Serious Adverse Events (SAEs) and e-SUSAR forms and logs
Completed Pregnancy Reporting Form
Notification of Urgent Safety Measures
24 hrs contact card for blinded trials
Emergency Un-blinding SOP (if applicable)
Notification of Safety Information to Investigators and relevant journal information
regarding IMP
Development Safety Update Report (DSUR) and documentation of submission to
MHRA and REC.
Other
14.0 MONITORING
Trial Site Initiation Report/letter/slides
Pharmacy Initiation Summary letter
Letter/email of Intent to Monitor Site (site visits only)
Sponsor Monitoring Reports (site visits only)
Completed UK Compliance reports from Site
CI’s review of PI UK compliance reports
JRO review of CI/PI UK compliance reports
Trial Monitoring Visit Log
Trial Close Out Checklist
Related Correspondence
Other
15.0 AUDITS & INSPECTIONS
Letter of Intent to Audit by Sponsor Rep or External Rep
Audit Summary Report for Site (where applicable to that site)
Other
16.0 CORRESPONDENCE
Emails/Letters
Phone call logs
Other
17.0 CENTRAL LABORATORIES/SAMPLES
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Accreditation Certificates/Conformity Documentation
Other
18.0 PROCEDURAL DOCUMENTS
Insert Date
when Filed.
Insert NA if not
applicable
Trial Specific SOPs (if applicable)
JRO SOPs
Other
19.0 SITE SPECIFIC DOCUMENTS (per site) Chief Investigator TMF
Agreements
CTSA (Clinical Trial Site Agreement including pharmacy/laboratory and material
transfer agreement)
Other
NHS Permissions (UK sites only)
Copy of signed SSI form
Copy of signed NHS permission Form
Local R&D NHS Permission Letter
Local R&D Substantial Amendment submission/ approvals/acknowledgement
Site Staff
Staff Signature and Delegation of Tasks Log
CI/PI CVs and GCP certificate(s)
Staff CVs and GCP certificates (if CI site only)
IMP (Note may be located in separate pharmacy file)
Local dispensing/pharmacy procedure SOPs
IMP Ordering and Shipping Records
Completed IMP prescriptions
IMP Accountability Form – completed
IMP Storage Records
IMP Temp records
IMP Destruction Log - completed
Laboratory
Local Laboratory Certification/Accreditation (if applicable)
Laboratory Reference Ranges (if applicable)
Sample Retention Records
Site Patient Activity
Open to recruitment letter
Completed Patient screening log
Completed Subject Enrolment, Withdrawal and Completion log,
Subject ID Code List
Protocol Deviation log
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