investigator study file

Developed by Klinikos;Roy Fraser (2012)

Investigator Study FileInvestigator Study File

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

CONTAINS ESSENTIAL DOCUMENTS THAT ALLOWS EVALUATION OF THE CONDUCT OF THE TRIAL

SERVES TO DOMONSTRATE COMPLIANCE WITH ICH-GCP


Investigator study file purposeInvestigator study file purpose

Example Investigator study file contentsExample Investigator study file contents

1. Contact Sheet2. Log of Monitoring Visits3. Patient Enrolment4. Correspondence5. Adverse Events6. Trial Products7. Randomisation8. Laboratories9. Protocol10. Ethics 11. Trial Approval12. Agreements & Finance13. Trial Personnel & Training14. Investigator Brochure15. Signed Consent Forms16. Source Documents17. Data Queries & Resolutions18. Final Report19. Completed CRFs


List all trial personnel; with addresses, telephone, fax numbers and email (laminated).


1. Contact Sheet1. Contact Sheet

Check up to date.

Visit reports are filed ( If required).


2. Log of monitoring visits2. Log of monitoring visits

Patient screening log.

Patient enrolment log.

Patient identification log.


3. Patient enrolment3. Patient enrolment

All communication between primary investigator & sponsor/funder:

Documents from primary investigator

Emails

Chronological order


4. Correspondence4. Correspondence

Copy of Adverse Event/Serious Adverse Events Forms.

Copy of communication with Regulatory Authority.


5. Adverse events5. Adverse events

Copy of Labelling details.

Receipt of I.M.P.

Copy of dispensing information.

I.M.P. dispensing/returns record.


6. Trial products (pharmacy)6. Trial products (pharmacy)

7. Randomisation7. 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.


8. Laboratories8. 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.


9. Protocol9. Protocol

10. Ethics10. 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.


11. Trial Approval11. Trial Approval

12. Agreements and Finance12. Agreements and Finance

Financial Agreements.

Indemnity / Insurance.

Outsourcing agreements.

Confidentiality / Disclosure agreements.

Copy of archive arrangements.


13. Trial personnel and training13. 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 Brochure14. Investigator Brochure

Copy of current Investigator Brochure.

Copy of any ancillary trial product information.


15. Signed Consent Forms15. Signed Consent Forms

Copy of blank consent form on letterhead plus any previous versions.

Actual patient signed Consent Forms


16. Source Documents16. Source Documents

Any source data generated for the trial: (Copies of X-ray reports, Endoscopy)


17. Data queries and resolutions17. Data queries and resolutions

Copy of signed data queries.


18. Final Report18. Final Report

Copy of final report.


19. Completed case report forms19. Completed case report forms

All copies of CRFs (if required in Site File).


investigator study file

Documents

headed paper

patient enrolment log

patient lab

patient identification

final protocol

final consent form

screening log

copy of communication