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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
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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
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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
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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
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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
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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
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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
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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
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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
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MONITORING VISIT REPORTS
To document site visits by, and findings of, the monitor
Located in Files of: SPONSOR
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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
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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
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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
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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)
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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)
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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
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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
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NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
Notification by sponsor to investigators of safety information
Located in Files of: INVESTIGATOR and SPONSOR
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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)
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SUBJECT SCREENING LOG
To document identification of subjects who entered pre-trial screening
Located in Files of: INVESTIGATOR and SPONSOR (where required)
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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
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SUBJECT ENROLMENT LOG
To document chronological enrolment of subjects by trial number
Located in Files of: INVESTIGATOR
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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
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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
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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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