1. Developed by Klinikos; Roy Fraser (2012) Investigator Study File www.klinikos.com www.linkedin.com/company/klinikos-ltd

2.  CONTAINS ESSENTIAL DOCUMENTS THAT ALLOWS EVALUATION OF THE CONDUCT OF THE TRIAL  SERVES TO DOMONSTRATE COMPLIANCE WITH ICH-GCP www.klinikos.com www.linkedin.com/company/klinikos-ltd Investigator study file purpose

3. 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 www.klinikos.com www.linkedin.com/company/klinikos-ltd

4.  List all trial personnel; with addresses, telephone, fax numbers and email (laminated). www.klinikos.com www.linkedin.com/company/klinikos-ltd 1. Contact Sheet

5.  Check up to date.  Visit reports are filed ( If required). www.klinikos.com www.linkedin.com/company/klinikos-ltd 2. Log of monitoring visits

6.  Patient screening log.  Patient enrolment log.  Patient identification log. www.klinikos.com www.linkedin.com/company/klinikos-ltd 3. Patient enrolment

7.  All communication between primary investigator & sponsor/funder:  Documents from primary investigator  Emails  Chronological order www.klinikos.com www.linkedin.com/company/klinikos-ltd 4. Correspondence

8.  Copy of Adverse Event/Serious Adverse Events Forms.  Copy of communication with Regulatory Authority. www.klinikos.com www.linkedin.com/company/klinikos-ltd 5. Adverse events

9.  Copy of Labelling details.  Receipt of I.M.P.  Copy of dispensing information.  I.M.P. dispensing/returns record. www.klinikos.com www.linkedin.com/company/klinikos-ltd 6. Trial products (pharmacy)

10. 7. Randomisation  Copy of Randomisation Schedule.  Sealed Randomisation envelopes.  Code Breaks.  Code Breaks activation documentation. www.klinikos.com www.linkedin.com/company/klinikos-ltd

11.  Name and address of clinical laboratory.  Laboratory accreditation certification.  Instructions.  Record of retained tissue, samples and location & I.D.  Normal ranges.  Patient Lab results. www.klinikos.com www.linkedin.com/company/klinikos-ltd 8. Laboratories

12.  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. www.klinikos.com www.linkedin.com/company/klinikos-ltd 9. Protocol

13. 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. www.klinikos.com www.linkedin.com/company/klinikos-ltd

14.  Copy of letter of regulatory approval form Competent Authority. www.klinikos.com www.linkedin.com/company/klinikos-ltd 11. Trial Approval

15. 12. Agreements and Finance  Financial Agreements.  Indemnity / Insurance.  Outsourcing agreements.  Confidentiality / Disclosure agreements.  Copy of archive arrangements. www.klinikos.com www.linkedin.com/company/klinikos-ltd

16. 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) www.klinikos.com www.linkedin.com/company/klinikos-ltd

17. 14. Investigator Brochure  Copy of current Investigator Brochure.  Copy of any ancillary trial product information. www.klinikos.com www.linkedin.com/company/klinikos-ltd

18. 15. Signed Consent Forms  Copy of blank consent form on letterhead plus any previous versions.  Actual patient signed Consent Forms www.klinikos.com www.linkedin.com/company/klinikos-ltd

19. 16. Source Documents  Any source data generated for the trial:  (Copies of X-ray reports, Endoscopy) www.klinikos.com www.linkedin.com/company/klinikos-ltd

20. 17. Data queries and resolutions  Copy of signed data queries. www.klinikos.com www.linkedin.com/company/klinikos-ltd

21. 18. Final Report  Copy of final report. www.klinikos.com www.linkedin.com/company/klinikos-ltd

22. 19. Completed case report forms  All copies of CRFs (if required in Site File). www.klinikos.com www.linkedin.com/company/klinikos-ltd