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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
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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
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INFORMED CONSENT FORM (including all applicable translations)
Puropse: to document the informed consent
File location: INVESTIGATOR and SPONSOR
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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
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ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used)
Purpose: to document the recruitment measure are appropriate and not coerceive
File location: INVESTIGATOR
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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
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INSURANCE STATEMENT (where required)
Purpose: to document the compensation to subject(s) for trial-related injury will be available
File location: INVESTIGATOR and SPONSOR
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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
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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
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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)
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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)
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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
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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
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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
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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
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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
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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
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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
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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)
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MASTER RANDOMISATION LIST
To document method for randomisation of trial population
File location: SPONSOR (third party if applicable)
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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
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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
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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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