ICH E6 Guideline for Good Clinical Practice

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Author:
Creativecris1
ID:
43987
Filename:
ICH E6 Guideline for Good Clinical Practice
Updated:
2010-10-22 15:48:23
Tags:
Essential Documents
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Description:
The following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available
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  1. INVESTIGATOR’S BROCHURE UPDATES
    To document that investigator is informed in a timely manner of relevant information as it becomes available

    Located in Files of: INVESTIGATOR and SPONSOR
  2. ANY REVISION TO:- protocol/amendment(s) and CRF- informed consent form- any other written information provided to subjects- advertisement for subject recruitment(if used)
    To document revisions of these trial related documents that take effect during trial

    Located in Files of: INVESTIGATOR and SPONSOR
  3. DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:- protocol amendment(s)- revision(s) of:- informed consent form- any other written information to be provided to the subject- advertisement for subject recruitment (if used)- any other documents given approval/favourable opinion- continuing review of trial (where required)
    To document that the amendment(s) and/or revision(s) have been subject to IRB/IEC review and were given approval/favourable opinion. To identify the version number and date of the document(s).

    Located in Files of: INVESTIGATOR and SPONSOR
  4. REGULATORY AUTHORITY(IES) AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED FOR:- protocol amendment(s) and other documents
    To document compliance with applicable regulatory requirements

    Located in Files of: INVESTIGATOR (where applicable) and SPONSOR
  5. CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB-INVESTIGATOR(S)
    To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects

    Located in Files of: INVESTIGATOR and SPONSOR
  6. UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S) INCLUDED IN THE PROTOCOL
    To document normal values and ranges that are revised during the trial

    Located in Files of: INVESTIGATOR and SPONSOR
  7. UPDATES OF MEDICAL/LABORATORY/ TECHNICAL PROCEDURES/TESTS- certification or- accreditation or- established quality control and/or external quality assessment or- other validation (where required)
    To document that tests remain adequate throughout the trial period

    Located in Files of: INVESTIGATOR (where applicable) and SPONSOR
  8. DOCUMENTATION OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT
    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

    Located in Files of: INVESTIGATOR and SPONSOR
  9. CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS
    To document identity, purity, and strength of investigational product(s) to be used in the trial


    Located in Files of: SPONSOR
  10. MONITORING VISIT REPORTS
    To document site visits by, and findings of, the monitor

    Located in Files of: SPONSOR
  11. RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS- letters- meeting notes- notes of telephone calls
    To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting

    Located in Files of: INVESTIGATOR and SPONSOR
  12. SIGNED INFORMED CONSENT FORMS
    To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission

    Located in Files of: INVESTIGATOR
  13. SOURCE DOCUMENTS
    To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject

    Located in Files of: INVESTIGATOR
  14. SIGNED, DATED AND COMPLETEDCASE REPORT FORMS (CRF)
    To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded

    Located in Files of: INVESTIGATOR (copy) and SPONSOR (original)
  15. DOCUMENTATION OF CRF CORRECTIONS
    To document all changes/additions or corrections made to CRF after initial data were recorded

    Located in Files of: INVESTIGATOR (copy) and SPONSOR (original)
  16. NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
    Notification by originating investigator to sponsor of serious adverse events and related reports

    Located in Files of: INVESTIGATOR and SPONSOR
  17. NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION
    Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions and of other safety information

    Located in Files of: INVESTIGATOR (where required) and SPONSOR
  18. NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
    Notification by sponsor to investigators of safety information

    Located in Files of: INVESTIGATOR and SPONSOR
  19. INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
    Interim or annual reports provided to IRB/IEC and to authority(ies)

    Located in Files of: INVESTIGATOR and SPONSOR (where required)
  20. SUBJECT SCREENING LOG
    To document identification of subjects who entered pre-trial screening

    Located in Files of: INVESTIGATOR and SPONSOR (where required)
  21. SUBJECT IDENTIFICATION CODE LIST
    To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject

    Located in Files of: INVESTIGATOR
  22. SUBJECT ENROLMENT LOG
    To document chronological enrolment of subjects by trial number

    Located in Files of: INVESTIGATOR
  23. INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE
    To document that investigational product(s) have been used according to the protocol

    Located in Files of: INVESTIGATOR and SPONSOR
  24. SIGNATURE SHEET
    To document signatures and initials of all persons authorised to make entries and/or corrections on CRFs

    Located in Files of: INVESTIGATOR and SPONSOR
  25. RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)
    To document location and identification of retained samples if assays need to be repeated

    Located in Files of: INVESTIGATOR and SPONSOR

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