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Learn andRefresh
FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & InvestigatorResponsibilitiesCanary Ltdwww.canarybooks.com
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Learn & Refresh – Card 9FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:Can an Institutional ReviewBoard (IRB) waive the need for informed consent inemergency research?
Answer:Yes. The IRB responsible for thereview, approval and continuing reviewof the clinical investigation mayapprove the investigation withoutrequiring such informed consent.However, a number of conditionsmust be met, as described in 21 CFR Part 50.24.
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Learn & Refresh – Card 10FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:How many basic elementsof informed consent aredescribed in 21 CFR Part 50.25?
Answer:Eight
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Learn & Refresh – Card 21FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:How should informed consentbe documented?
Answer:By the use of a written consent formapproved by the IRB and signed anddated by the subject or the subject’slegally authorized representative at thetime of consent(21 CFR Part 50.27)
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Learn & Refresh – Card 22FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:Who should receive a copyof the consent form?
Answer:A copy shall be given to the personsigning the form(21 CFR Part 50.27)
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Learn & Refresh – Card 33FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:What does an investigatoragree to by signing FormFDA 1572 regardingkeeping documents?
Answer:The investigator agrees to maintainadequate and accurate records (asrequired by 21 CFR Part 312.62) andto make those records available forinspection
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Learn & Refresh – Card 34FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:True or false? The investigatoris accountable for regulatoryviolations resulting from failureto adequately supervise theconduct of the clinical study.
Answer:True(FDA Guidance for Industry,Investigator Responsibilities)
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Learn & Refresh – Card 41FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:Does a sponsor have to submitthe signed Form FDA 1572,Statement of Investigator, tothe FDA?
Answer:No. Although the sponsor is required to collectthe Form FDA 1572 from the investigator, theFDA does not require the form to be submittedto the agency. However, many sponsors dosubmit Form FDA 1572 to the FDA because itcollects, in one place, information that must besubmitted to the FDA under 21 CFR Part312.23 (a)(6)(iii)(b).(Frequently Asked Questions –Statement ofInvestigator (Form FDA 1572))
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Learn & Refresh – Card 42FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:What should an investigator do ifinformation in a submitted Form FDA 1572 changes?
Answer: If there are changes to information contained in asigned and dated Form FDA 1572 (eg. an IRBaddress change, the addition of new sub-investigators, the addition of a clinical researchlaboratory), the investigator should document thechanges in the clinical study records and inform thesponsor of these changes, so that the sponsor canappropriately update the IND application. The FormFDA 1572 itself does not need to be revised and anew Form FDA 1572 does not need to becompleted and signed by the investigator.(Frequently Asked Questions –Statement ofInvestigator (Form FDA 1572))
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Learn & Refresh – Card 51FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:When might an IRB requireadditional safeguards toprotect the rights and welfareof trial subjects?
Answer:When some or all of the subjects –such as children, prisoners, pregnantwomen, handicapped or mentallydisabled persons, or economically oreducationally disadvantaged persons –are likely to be vulnerable(21 CFR Part 56.111 (b))
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Learn & Refresh – Card 52FDA Regulations (Part 2) 21 CFR Parts 50 & 56, Form FDA 1572 & Investigator Responsibilities Canar y
© Canary Ltd, 2011
Question:Can you name three studytasks where an investigatormay delegate inappropriately?
Answer:•Taking medical histories•Checking inclusion/exclusion criteria•Physical examinations•Evaluation of adverse events•Assessment of primary endpoints•Obtaining informed consent•Providing medical care during the course
of the study
(FDA Guidance for Industry, InvestigatorResponsibilities)
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