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

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

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

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

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

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

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

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

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

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

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

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

 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.
10. Ethics www.klinikos.com www.linkedin.com/company/klinikos-ltd

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

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

 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)
13. Trial personnel and training www.klinikos.com www.linkedin.com/company/klinikos-ltd

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

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

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

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

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

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