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Investigator Study File

Investigator Study File. Developed by Klinikos; Roy Fraser (2012). CONTAINS ESSENTIAL DOCUMENTS THAT ALLOWS EVALUATION OF THE CONDUCT OF THE TRIAL SERVES TO DOMONSTRATE COMPLIANCE WITH ICH-GCP. Investigator study file purpose. Contact Sheet Log of Monitoring Visits

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Investigator Study File

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

  3. 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

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

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

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

  7. 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

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

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

  10. Copy of Randomisation Schedule. • Sealed Randomisation envelopes. • Code Breaks. • Code Breaks activation documentation. 7. Randomisation 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. 8. Laboratories www.klinikos.com www.linkedin.com/company/klinikos-ltd

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

  13. 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

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

  15. 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

  16. 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

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

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

  19. 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

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

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

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

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