INVESTIGATOR SITE FILE CHECKLIST

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 receipt
Superseded Approved Protocol(s)

3  Participant Information Sheet And Consent Form (ON LOCAL HEADED PAPER)

3.1  Patient Information Sheet (PIS)

Current Approved PIS Template
Superseded Approved PIS(s) Templates

3.2  Informed Consent Form (ICF)

Current Approved ICF Template
Superseded Approved ICF Template

3.3  GP Letter

Current Approved Letter/Information for Patient’s GP
Superseded Approved GP Letter/Information for Patient’s GP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Superseded Approved Recruitment Advertisement(s)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 Sponsorship
Insurance and Indemnity Certificate(s)
Trial Closure Notification and archiving documentation

5.2  Research and Development

Signed SSI Form and local approvals, including any amendments
NHS/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/instructions
Patient Screening Log
Patient Enrolment Log
Completed Patient Consent Forms

10.2  Study Data

Completed CRFs /eCRFs
Documentation of CRF corrections and data queries

11  Data management

11.1  Case Report Forms

Sample Case Report Form(s) / eCRFs
Superseded Case Report Form(s) /eCRFs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 updates
Monitoring 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, Minutes

14  CORRESPONDENCE

JRMO Investigator Site File Checklist Template v0.1 Page 1 of 4