Developed by Klinikos; Roy Fraser (2012) Investigator Study File

 CONTAINS ESSENTIAL DOCUMENTS THAT ALLOWS EVALUATION OF THE CONDUCT OF THE TRIAL  SERVES TO DOMONSTRATE COMPLIANCE WITH ICH-GCP Investigator study file purpose

Example Investigator study file contents 1. Contact Sheet 2. Log of Monitoring Visits 3. Patient Enrolment 4. Correspondence 5. Adverse Events 6. Trial Products 7. Randomisation 8. Laboratories 9. Protocol 10. Ethics 11. Trial Approval 12. Agreements & Finance 13. Trial Personnel & Training 14. Investigator Brochure 15. Signed Consent Forms 16. Source Documents 17. Data Queries & Resolutions 18. Final Report 19. Completed CRFs

 List all trial personnel; with addresses, telephone, fax numbers and (laminated) Contact Sheet

 Check up to date.  Visit reports are filed ( If required) Log of monitoring visits

 Patient screening log.  Patient enrolment log.  Patient identification log Patient enrolment

 All communication between primary investigator & sponsor/funder:  Documents from primary investigator  s  Chronological order Correspondence

 Copy of Adverse Event/Serious Adverse Events Forms.  Copy of communication with Regulatory Authority Adverse events

 Copy of Labelling details.  Receipt of I.M.P.  Copy of dispensing information.  I.M.P. dispensing/returns record Trial products (pharmacy)

7. Randomisation  Copy of Randomisation Schedule.  Sealed Randomisation envelopes.  Code Breaks.  Code Breaks activation documentation.

 Name and address of clinical laboratory.  Laboratory accreditation certification.  Instructions.  Record of retained tissue, samples and location & I.D.  Normal ranges.  Patient Lab results Laboratories

 Signed Final Protocol (plus earlier versions).  Signed Amendments.  Sample CRF.  Final Patient Information Sheet (on headed paper).  Final Consent Form (on headed paper).  G.P. Letter (on headed paper)- if required Protocol

10. Ethics  Copy of name and address of Ethics Committee (E.C.)  Composition of Ethics Committee  Copy of application form  Copy of protocol reviewed by E.C.  Letter of approval (stating what has been approved)  Copy of updates on progression of trial by E.C.  Copy of notification of trial completion and report summary to E.C  Notification of adverse events to E.C.

 Copy of letter of regulatory approval form Competent Authority Trial Approval

12. Agreements and Finance  Financial Agreements.  Indemnity / Insurance.  Outsourcing agreements.  Confidentiality / Disclosure agreements.  Copy of archive arrangements.

13. Trial personnel and training  Signed & Dated C.V.’s of Study Team - (eg P.I., Research Nurses, Pharmacist)  Authorisation/delegation Log  Copy of Investigator GCP responsibilities  Copy of pre study and initiation visit reports  Copy of any special instructions  Evidence of staff training (Certificates, Inductions)

14. Investigator Brochure  Copy of current Investigator Brochure.  Copy of any ancillary trial product information.

15. Signed Consent Forms  Copy of blank consent form on letterhead plus any previous versions.  Actual patient signed Consent Forms

16. Source Documents  Any source data generated for the trial:  (Copies of X-ray reports, Endoscopy)

17. Data queries and resolutions  Copy of signed data queries.

18. Final Report  Copy of final report.

19. Completed case report forms  All copies of CRFs (if required in Site File).