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CCRA Exam Questions And Answers With Latest Quiz What is 21 CFR 812? ✅ IDE What is 21 CFR 600? ✅ Biological Products What is 21 CFR 11? ✅ Electronic Records What is 21 CFR 50? ✅ Informed Consent What is ICH E6: 8 ✅ Essential Documents What is the purpose of maintaining study document and records? ✅ Insure compliance; dealing with safety of patient, things have to be written down What are source document? ✅ First place data is written What are case report forms? ✅ Provides format for collecting protocol -required data What is a Confidentiality Agreement? ✅ Sponsor can protect information, don't want the researcher to disclose information What is FDA 1572? ✅ Legal contract between FDA and the investigator for investigational drug studies What is the device equivalent of form FDA 1572? ✅ Investigator Agreement or a Statement of Investigator What law requires a CV for PI? ✅ 21 CFR 312; 21 CFR 812 What is the Financial Disclosure Certification (absense of financial interest) form? ✅ Form 3454 What is the Financial Disclosure form for stating financial interest? ✅ Form 3455 How long must the sponsor disclose financial interests? ✅ One Year How long must the sponsor maintain records after approval of the marketing application? ✅ 2 years Why is it important to have a Delagation of Authority Log? ✅ Whoever is doing that specific treatment is trained; who is allowed to do what at each siteLos beneficios de comprar resúmenes en Stuvia estan en línea:
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