Investigator Site File (ISF)Device Index

Short Title: / IRAS ID:
R&D number:
Chief Investigator (CI): / Principal Investigator (PI):
Sponsor Contacts:
Table of content: / Yes / N/A
Protocol
1.1 / Final Approved Protocol (signed and dated)
1.2 / Superseded Version(s) of the Protocol
1.3 / Protocol Amendment(s) (tracked changes)
Subject/Patient Information
2.1 / Final Approved Patient/Subject Information Sheet (PIS)/(SIS)
2.2 / Final Approved Informed Consent Form (ICF)
2.3 / Signed Informed Consent Forms
2.4 / Final Approved GP Letter, Parent’s letter and patient invitation
2.5 / Superseded PIS,CF and GP letter
2.6 / Patient Materials (Diaries/Questionnaires etc)
2.7 / Advertisements for Recruitment
Study Logs & Records – completed and blank forms
3.1 / Delegation of Responsibilities and Staff Signature Log
3.2 / Patient Screening Log
3.3 / Patient ID Log
3.4 / Enrolment, Withdrawal and Completion Log
3.5 / GP Letter Log
3.6 / Log of Protocol Deviations/serious Breaches
3.7 / Adverse Event log
3.8 / Log of Telephone Calls (if applicable)
3.9 / Protocol Training log
3.10 / Log of protocol related team meetings
3.11 / Minutes of protocol related team meetings
3.12 / Sponsor SOP training log
Contact Details
4.1 / Sponsor Contact Details
4.2 / Study site Personnel Contact Details
4.3 / CV & GCP Certificates for each person on delegation log (3.1)
4.4 / Honorary Contract for non-NHS Staff
4.5 / Research Passport
Data Management and Statistical Analysis
5.1 / Final version of trial CRF(s) (with Instructions for completion if applicable)
5.2 / Randomisation Procedure (if applicable)
5.3 / Signed, dated and completed CRFs (or a File Note with location)
5.4 / Data queries (and/or documentation on CRF correction) Copy- Original to TMF
5.5 / Interim Data Analysis (if applicable)
6 / Study Amendments
Log/Summary of Amendment(s) &approval dates / YES
Amendment number / MHRA approval Y- date/ - N/A / Ethics approval Y - date ‘/ N/A / HRA approval date / Date Approved for use
7 / Local R&D Approval & Site Specific Documents
7.1 / Statement of Activities (signed and dated)
7.2 / Site confirmatory statement
7.3 / Schedule of Events
7.4 / Patient Identification Centre (PIC) Approval (if applicable)
8 / Medicines and Healthcare Regulatory Agency (MHRA)
8.1 / Notice of Acceptance Letter
8.2 / Serious Breach notification(s) and related correspondence
8.3 / Declaration of the End of Trial (DET) & MHRA acknowledgement
8.4 / Clinical Study Report
9 / HRA/Research Ethics Committee
9.1 / HRA Initial assessment Letter
9.2 / HRA approval
9.3 / REC Composition and Validation Letter
9.4 / REC Favorable opinion Letter
9.5 / Annual Progress Report(s) (APR) and acknowledgements / YES
Year :
Year:
Year:
Year:
Year:
9.7 / End of Trial Notification
9.8 / REC acknowledgement
10 / Pharmacovigilance (PVG)
10.1 / JREOSOP0006 Instructions for reporting SAEs/SUSARs
10.2 / Adverse Events (AE) Logs (completed as agreed in the study protocol)
10.3 / SAE report(s) and follow-up information
10.4 / SUSAR report(s)
10.5 / Urgent Safety Measures (if applicable)
10.6 / 24hr contact cards (for blinded trials)
10.7 / Notification of safety information from Sponsor
10.8 / Development Safety Update Report (DSUR) and acknowledgements / YES
Year :
Year:
Year:
Year:
Year:
11. / Monitoring
11.1 / Monitoring Visit Log
11.2 / Monitoring Plan
11.3 / Source Document Memo
11.4 / Initiation Meeting Report and supporting documents
11.5 / Sponsor Open to recruitment letter
11.6 / Monitoring Reports per visit
Monitoring Visit Number / Report / Queries raised / Resolved
11.7 / Close-out study report
12. / Medical Device
12.1 / Medical Device Brochure (IB)/ Instruction manual
12.2 / CE Certification
12.3 / Device Shipment Record
12.4 / Temperature Log template
12.5 / Temperature Deviation log (if applicable)
12.6 / Device accountability log template
12.7 / Device destruction log template
12.8 / Master Randomisation list (if applicable)
12.9 / Treatment allocation
12.10 / Related correspondence
13 / Central Laboratory
13.1 / List of Local Laboratories (if applicable)
13.2 / Laboratory Accreditation Certificate(s)
13.3 / Normal Reference Ranges and update(s)
13.4 / Sample Shipment Record(s)
13.5 / Record of retained of body fluids
13.6 / Sample Storage Box map (if applicable)
13.7 / SOPs / Instruction manuals for trial specific procedures
13.8 / HTA registration form submitted to JREO
Agreements/Finance/Sponsorship
14.1 / Sponsorship Letter/DDSA Agreements
14.2 / Insurance/Indemnity Statement
14.3 / Clinical Trials Site Agreement (CSTA)
14.4 / Device Supply Agreements
14.5 / Funding Agreement
14.6 / CRO Agreement (if applicable)
14.7 / Signed Agreements between involved parties
14.8 / Other Agreements
Correspondence
15.1 / Trial Correspondence
Study Specific Procedures
16.1 / Study Specific SOPs (including Sponsor SOPs)
16.2 / Study Specific Instruction Manuals
Archiving Arrangements
17.1 / Archiving Procedure JREOSOP0016 (If not applicable please file local SOP procedure)
17.2 / Archiving Personnel Details

STUDY TITLE ISFDevice Index, V2.0, 02 Jan 2018

JREODOC0099

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