1 Administrative
1.1 Contact List (Contact details for site staff and coordinating centre)
1.2 Version Control Log
2 Study Protocol
Current Approved Version (Signed), including acknowledgement of receiptSuperseded Approved Protocol(s)
3 Participant Information Sheet And Consent Form (ON LOCAL HEADED PAPER)
3.1 Patient Information Sheet (PIS)
Current Approved PIS TemplateSuperseded Approved PIS(s) Templates
3.2 Informed Consent Form (ICF)
Current Approved ICF TemplateSuperseded Approved ICF Template
3.3 GP Letter
Current Approved Letter/Information for Patient’s GPSuperseded Approved GP Letter/Information for Patient’s GP
3.4 Other Ethics Approved Information Given to Patients
Current Approved Recruitment Advertisement(s)Superseded Approved Recruitment Advertisement(s)
4 REC (Ethics)
4.1 Ethics Application
Amendments (Full submission package and approval)Original Ethics Application Submission Package (Full submission package and approval)
4.2 Ethics Annual Progress Report(s)
4.3 Ethics Study Closure notification and acknowledgment including submitted Clinical Study Report
5 Sponsor / Research & Development
5.1 Sponsor
Letter of confirmation of SponsorshipInsurance and Indemnity Certificate(s)
Trial Closure Notification and archiving documentation
5.2 Research and Development
Signed SSI Form and local approvals, including any amendmentsNHS/HSC R&D Form
Completed Feasibility questionnaire
6 Finance and contracts
6.1 Finance
Copy of financial information relating to the study (invoices etc.)6.2 Contract(s)
Contracts (e.g. signed Site Agreement)Confidentiality Agreement(s)
7 Research Team – Staff and Training
7.1 Delegation Duties Log for Site Team
7.2 Signed & Dated CVs & GCP Certificates for Site Team
7.3 Study-specific training records
8 Pharmacovigilance
8.1 AE Reporting Procedures
8.2 List of Reported AEs and acknowledgements of AE form receipt by Sponsor
9 Intervention
9.1 Operation Manual
10 Patient data
10.1 Patient enrolment
Randomisation or enrollment procedure/instructionsPatient Screening Log
Patient Enrolment Log
Completed Patient Consent Forms
10.2 Study Data
Completed CRFs /eCRFsDocumentation of CRF corrections and data queries
11 Data management
11.1 Case Report Forms
Sample Case Report Form(s) / eCRFsSuperseded Case Report Form(s) /eCRFs
CRF completion guidelines
11.2 Deviations and Potential Serious Breaches
12 Monitoring and Audits
12.1 Monitoring
SIV documentation incl presentation, attendance log and updatesMonitoring documentation incl email, report, attendance log and updates
Close out visit documentation incl letter, report, attendance log and updates
12.2 Audit /Inspection Certificates
13 Committees and Meetings
13.1 Investigator Meetings or other meetings as appropriate
Agenda, Presentations, Minutes14 CORRESPONDENCE
JRMO Investigator Site File Checklist Template v0.1 Page 1 of 4