ICH E6 Guideline for Good Clinical Practice

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Author:
Creativecris1
ID:
43981
Filename:
ICH E6 Guideline for Good Clinical Practice
Updated:
2010-10-22 15:48:57
Tags:
Essential Documents
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Description:
The following documents should be generated and on file before the trial formally starts
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  1. INVESTIGATOR BROCHURE
    Purpose: to document that relevant and current scientific information about the investigational product has been provided to the investigator

    File location: INVESTIGATOR and SPONSOR
  2. SIGNED PROTOCOL AND AMENDMENTS, IN ANY, AND SAMPLE CASE REPORT FORM (CRF)
    Purpose: to document investigator and sponsor agreement to the protocol/amendment(s) and CRF

    File location: INVESTIGATOR and SPONSOR
  3. INFORMED CONSENT FORM (including all applicable translations)
    Puropse: to document the informed consent

    File location: INVESTIGATOR and SPONSOR
  4. ANY OTHER WRITTEN INFORMATION
    Purpose: to document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent

    File location: INVESTIGATOR and SPONSOR
  5. ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used)
    Purpose: to document the recruitment measure are appropriate and not coerceive

    File location: INVESTIGATOR
  6. FINANCIAL ASPECTS OF THE TRIAL
    Purpose: to document the financial agreement between the investigator/institution and the sponsor for the trial

    File location: INVESTIGATOR and SPONSOR
  7. INSURANCE STATEMENT (where required)
    Purpose: to document the compensation to subject(s) for trial-related injury will be available

    File location: INVESTIGATOR and SPONSOR
  8. SIGNED AGREEMENT BETWEEN INVOLVED PARTIES
    Purpose: to document agreements

    investigator and sponsor INVESTIGATOR and SPONSOR

    investigator and CRO INVESTIGATOR and SPONSOR (where required)

    sponsor and CRO SPONSOR

    investigator and authority(ies) (where required) INVESTIGATOR and SPONSOR
  9. DATED, DOCUMENTED APPROVAL/FAVORABLE OPINION OF THE INSTITUTIONAL REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
    protocol and any amendements
    CRF (if applicable)
    informed consent form(s)
    any other written information to be provided to the subject (s)
    advertisement for subject recruitment (if used)
    subject compensation (if any)
    any other documents given approval/favorable opinion
    Purpose: To document that the trial has been subject toIRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)

    File location: INVESTIGATOR and SPONSOR
  10. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION
    To document that the IRB/IEC is constituted in agreement with GCP

    Located in Files: Investigator Sponsor (where required)
  11. REGULATORY AUTHORITY(IES)AUTHORISATION/APPROVAL/NOTIFICATION OF PROTOCOL(where required)
    To document appropriate authorisation/approval/notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)

    Located in Files: Investigator (where required) Sponsor (where required)
  12. CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S)
    To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects

    File location: INVESTIGATOR and SPONSOR
  13. NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL
    To document normal values and/or ranges of the tests

    File location: INVESTIGATOR and SPONSOR
  14. MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS- certification or- accreditation or- established quality control and/or external quality assessment or- other validation (where required)
    To document competence of facility to perform required test(s) , and support reliability of results

    File location: INVESTIGATOR (where required) and SPONSOR
  15. SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S)
    To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects

    File location: SPONSOR
  16. INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS(if not included in protocol or Investigator’s Brochure)
    To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials

    File location: INVESTIGATOR and SPONSOR
  17. SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
    To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability

    File location: INVESTIGATOR and SPONSOR
  18. CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED
    To document identity, purity, and strength of investigational product(s) to be used in the trial

    File location: SPONSOR
  19. DECODING PROCEDURES FOR BLINDED TRIALS
    To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects' treatment

    File location: INVESTIGATOR and SPONSOR (third party if applicable)
  20. MASTER RANDOMISATION LIST
    To document method for randomisation of trial population

    File location: SPONSOR (third party if applicable)
  21. PRE-TRIAL MONITORING REPORT
    To document that the site is suitable for the trial (may be combined with trial initiation monitoring report)

    File location: SPONSOR
  22. TRIAL INITIATION MONITORING REPORT
    To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be combined with pre-trial monitoring report)

    File location: INVESTIGATOR and SPONSOR
  23. When should the Trial Master File be established
    at the beginning of the trial, both at the investigator and sponsor sites

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