STHXXXXX
Research Department
Research Governance
Trial Master File* / Investigator Site File*
*delete as appropriate
This guidance applies to all research registered within STH Trust, regardless of design or location.
The Trial Master File/ Investigator Site File should contain the essential documents, which individually and collectively permit evaluation of the conduct of a research trial. The contents of the file serve to demonstrate the compliance of the investigator and the research team with the standards of Good Clinical Practice (GCP) and to the requirements of the Research Governance Framework.
The CI will keep a Trial Master File. The local PI will keep an Investigator Site File. In the case of a single centre study there will often be a single file for both CI and PI, in this case this file will be a Trial Master File.
The documents contained in the file are those that will be audited as part of the research governance process to confirm the validity of the trial conduct.
Those sections which do not apply to an Investigator Site File (where this file is not also acting as a Trial Master File) are greyed out in the ISF column. Some sections and sub-sections may not apply to all projects. If you are unsure about whether a particular element applies to your project, please seek advice from the Research Department.
Trial Master File* / Investigator Site File*
STH ref:NIHR CSP ref:
REC ref:
MHRA ref: / CTA No: / EudraCT No:
Study title:
Chief Investigator:
Principal Investigator:
Sponsor:
Funder:
Emergency contacts:
Name / Telephone inc extension / EmailChief Investigator
Principal Investigator
Sub Investigator
Research Nurse
Pharmacy
Out of Hours
Research Department coordinator
Other
(egextermal)
TMF* / ISF*
1Core Study Documents (current REC approved)
1.1 / Protocol
1.2 / Participant Information Sheet(s)
1.3 / Informed Consent Form(s)
1.4 / Information for GPs or consultants
1.5 / Letters of invitation to participants
1.6 / Questionnaires
1.7 / Participant Card / Diary
1.8 / Adverts for recruitment
1.9 / Interview Schedule
1.10 / Other REC approved documents
2 Independent Scientific Review
2.1 / Report / Evidence of independent scientific review
3 Ethics
3.1 / The Ethics Committee Approval letter
3.2 / Amendment Approvals/sponsor confirmation non-substantial amendment
3.3 / Amendment notification forms
3.4 / Application forms (original REC form)
3.5 / NIGB Documents
3.6 / Annual Progress Reports
3.7 / Annual Safety Reports
3.8 / All correspondence with the committee(s)
4 Regulatory Documents
4.1 / MHRA Notice of no objection
4.2 / MHRA Amendment approval
4.3 /
MHRA Application form forCTA (original and any amended forms)
4.4 /Investigator Brochure / SmPC/ IMP Dossier / CE-marked device instructions for use
4.5 /Annual Safety Reports/ DSUR
4.6 /Gene Therapy Advisory Committee documents
5 Research Governance Documents5.1 / Project registration form/Confirmation email
5.2 / SSI Form
5.3 / Research Department Authorisation Letter
5.4 / Research Department Amendments Letters/non-notifiable confirmation email
5.5 /
Insurance Certificate/ Indemnity arrangements
6 Financial Management6.1 / Signedsite agreement (and side letter where applicable)
Other signed financial agreements, service agreements, technical agreements and collaboration agreements
6.2 / Industry Costing template
6.3 / STH Finance form
6.4 / Funding application forms
6.5 / Confirmation of funding
7 Investigator, facilities and Research Team
7.1 / CI CV
7.2 / Local Principal Investigator CV
7.3 / Co-investigators CVs and training record, including GCP training
7.4 / Signature Log of all members of the research team
7.5 / List of tasks and responsibilities delegated to co-investigators
7.6 / Honorary Contracts/Letters of Access
8 Participant Information
8.1 / Original signed consent forms
8.2 / Participant enrolment log
8.3 / Participant tracking log
8.4 / Sample tracking log(for stored or shipped samples)
8.5 / Record of tapes and transcripts of interviews and focus groups
8.6 / SAE reports
8.7 / SAE log
8.8 / SUSAR reports
9 Project Management
9.1 / Terms of reference and minutes or other records of Steering Group and/or Data Monitoring Group meetings
9.2 / Monitoring arrangements
9.3 / Standard Operating Procedures for trial specific tests/interviews/
focus groups and the processing of study material/data
9.4 / Laboratory Accreditation certificate
9.5 / Normal laboratory values
9.6 / Blank copy of case report form/data collection sheet/interview schedule.
9.7 / Blank copy of SAE report form/ pregnancy report form
10 Pharmacy (file note for location if separate pharmacy file held)
10.1 / Pharmacy Arrangements (dispensing guide)
10.2 / Randomisation schedule/Treatment allocation procedures
10.3 / Code Break procedures/SOP
10.4 / Prescribing arrangements/ template prescription
10.5 / Dispensing log
10.6 / Drug Accountability (including drug shipment, patient compliance records and drug destruction records)
10.7 /
Sample drug labels
10.8 /IMP storage arrangements (including temperature log)
11Monitoring and Auditing11.1 / Records of internal monitoring
11.2 / Completed monitoring reports
11.3 / Monitoring log
11.4 / Protocol non-compliance reports and log
12 Study Closure
12.1 / Recruitment summary
12.2 / Archiving arrangements
12.3 / Dissemination: plans for/record of
12.4 / End of study declaration to REC and MHRA
12.5 / Final Report to REC and MHRA
13Correspondence
13.1 / All trial related correspondence other than as listed elsewhere
14Research Governance Compliance
14.1 / Declaration of Helsinki
14.2 / ICH Good Clinical Practice (GCP) booklet
15Superseded Documents
15.1 / Copy of all superseded study documents approved by site R&D Office for use (including documents not approved due to being non-notifiable amendments)
15.2 / Copy of all superseded study documents submitted to REC and/or Regulatory Authority.