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Investigator Site File
INDEX
Appendix 2
Please Note:


If the Investigator Site File for your trial site is combined with the Trial Master File please use the
alternative CI Trial Master File Index for your files.
Contents of the ISF may vary depending on trial specifics. Tick to indicate where an item is not
applicable to the trial.
TABLE OF CONTENT
Tick if not
applicable
ISF Index
Key Clinical Trial Contacts
1. SPONSORSHIP AND INSURANCE
Sponsorship Letter
Insurance/Indemnity Letter
Open to Recruitment Letter
Site Closedown Letter
Related Correspondence
2. FUNDING AND AGREEMENTS
Clinical Trial Site Agreement
Laboratory Services Agreement
Funding Arrangements/Agreements
Other Agreements (if applicable)
Related Correspondence
3. REGULATORY
Research Ethics Committee/GTAC Favourable Opinion Letter
(including composition of REC/GTAC committee)
MHRA Notice of Acceptance Letter (CTA)
Substantial and Non Substantial Amendment documentation (including where
applicable, Signed Annex 2, cover letter)
Amendment REC/GTAC/MHRA Approval Letter(s)
Log of Amendments
Annual Progress Reports (REC/GTAC)
End of Trial Notification
Related Correspondence
4. SITE SPECIFIC APPROVALS
IRAS R&D Form
IRAS Site Specific Information (SSI) Form (signed)
Trust R&D NHS permission letter / Site approval (NHS R&D Management Approval
letter for Research)
Trust R&D NHS permission letter / acknowledgement for Trial Amendments
Trust R&D notification of end of trial
ARSAC Licence
Genetic Modification Safety Committee Approval (for Gene Therapy Trials only)
Other Site Specific Approvals
Correspondence
5. PROTOCOL
Current Approved Protocol (signed by PI)
Superseded Protocol Versions (signed by PI)
Correspondence
6. PATIENT INFORMATION AND CONSENT
Current Patient/ Information Sheet and Consent Form (PIS)/ICF
(on Trust headed paper)
Current GP Letter (on Trust headed paper)
Superseded versions of Patient/ Information Sheet and Consent Form (PIS)/ICF, GP
letter
Patient Contact/Alert Card
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Original Signed Informed Consent Forms (per patient/donor)
Other
7. INVESTIGATIONAL MEDICNAL PRODUCT (IMP)
* Note maybe located in separate pharmacy/IMP file (if so file note location)
Summary of drug arrangements/IMP Management Plan
Current Investigator Brochure (IB) / Summary of Product Characteristics (SPC)
Superseded Investigator Brochure (IB) / Summary of Product Characteristics
(SPC)
Sample of Approved Label
Certified QP Release Statement
Master Randomisation List
Study Specific IMP Prescription Template
Completed IMP Prescriptions
IMP Shipment Records
IMP Accountability Logs
IMP Destruction Logs
IMP Storage Temperature Logs
Temperature Deviation Log
IMP Recalls
Other IMP Specific Forms / SOPs
Correspondence
8. PATIENT / SUBJECT IDENTIFICATION / DATA COLLECTION
Subject Identification and Code List
Subject Screening Log
Subject Enrolment, Withdrawal and Completion log
Subject Randomisation Log
Current Approved CRF
Superseded versions of CRFs
CRF Completion Instructions
Template Quality of Life Questionnaires and Patient Diaries
Superseded versions of Template Quality of Life Questionnaires and Patient
Diaries
Completed CRFs, Diary Cards and Quality of Life Questionnaires
Data Management SOP
Data Query Documentation
Protocol Deviation/Violation Log
Related Correspondence
9. STUDY SITE STAFF
Staff Signature and Delegation of Tasks Log
Staff CVs (signed and dated)
Staff Training Records (e.g. Protocol, GCP, study specific training)
(File note location if held separately)
Related Correspondence
10. PHARMACOVIGILANCE
Tick if not
applicable
Trial Specific SAE Reporting SOP
Sample SAE form and Pregnancy form
Completed Serious Adverse Events (SAEs) and e-SUSAR forms and logs
Completed Pregnancy Reporting Form
Notification of Urgent Safety Measures
Emergency Un-blinding SOP (if applicable)
Development Safety Update Reports (DSUR)
Related Correspondence
11. MONITORING & AUDIT
Trial Monitoring Visit Log
Trial Site Initiation Report/letter/slides
Pharmacy Initiation Summary letter
Sponsor Monitoring Reports / Summary Letters
Completed UK Compliance reports
Audit Summary Report for Site
Related Correspondence
12. LABORATORIES / SAMPLES
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Laboratory /Sample Processing Manual
Local Laboratory Certification/Accreditation
Local Laboratory Normal Ranges
Record of retained samples
Sample Shipment Records
List of trial specific Labs used with contact details
Other
Related Correspondence
13. PROCEDURAL DOCUMENTS
Trial Specific SOPs
Sponsor SOPs
14. CORRESPONDENCE
Emails/Letters
Phone call logs
Meeting Agendas/Minutes
Newsletters
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