How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working
days
How many members must sit on an IRB? - 5
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research
What are the criteria for IRB approval of research? (7) - 1. Risk...
CCRP Exam Questions & Answers | 100% Correct Answers | Verified | Latest 2024 Version How many days does a sponsor have to report an emergency use of an IP to the FDA? - ✔✔5 working days How many members must sit on an IRB? - ✔✔5 How long must an IRB retain records per 21 CFR 56? - ✔✔3 years after completion of research What are the criteria for IRB approval of research? (7) - ✔✔1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects How many days does an IRB have to report a change in registration information due to a change in chairperson or contact? - ✔✔90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? - ✔✔30 days How often must an IRB renew it's registration? - ✔✔3 years What are the 8 basic elements of informed consent per FDA guidelines? - ✔✔1. Statement that the study involves research, purpose and expected duration, description of experimental procedures 2. Description of reasonably foreseeable risks 3. Benefits 4. Disclosure of alternative procedures or courses of treatment 5. Confidentiality measures 6. Compensation and treatments available if injury occurs 7. contact information 8. Participation is voluntary and subject may discontinue at any time What are the criteria for involving children in minimal risk research? (2) - ✔✔1. No greater than minimal risk 2. Assent from kid + consent from parent obtained What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3) - ✔✔1. Risks are justified by benefits 2. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches 3. Assent + consent What are the criteria for involving children in greater than minimal risk research with no direct benefit? (4) - ✔✔1. Risks are minor increase over minimal risk 2. Intervention presents experiences that are reasonable commensurate with normal medical and living situations 3. Intervention is likely to yield generalizable knowledge that is vital 4. Assent + consent Sponsors must report SAEs to the FDA within how many days of discovering the event? - ✔✔15 calendar days (21 CFR 312.32) Investigators must report SAEs to a sponsor within how many days of discovering the event? - ✔✔Immediately (21 CFR 312.64) Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4) - ✔✔1) Serious and unexpected suspected adverse reactions 2) Findings from other studies that suggest a significant risk in humans 3) Findings from animal or in -vitro testing that suggest risks to humans 4) Increased rate of occurrence of serious suspected adverse reactions Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days? - ✔✔10 working days (21 CFR 812.15) Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days? - ✔✔10 working days (21 CFR 812.15) When was the Nuremberg Code issued? - ✔✔1947 What are the 10 points made in the Nuremberg Code? - ✔✔1) Voluntary informed consent should be obtained 2) Research should yield benefit to society 3) Research should be based on animal work 4) Avoid unnecessary suffering 5) Don't do research resulting in death or disabling injury 6) Risks should be justified by benefits 7) Proper prep and adequate facilities should be used 8) Conducted by scientifically qualified people 9) Subject can withdraw whenever 10) Researchers can end the study if risks are too great When was the Declaration of Helsinki released? - ✔✔1964 Who developed the Declaration of Helsinki? - ✔✔World Medical Association (WMA) What is the Declaration of Helsinki? - ✔✔Document that laid out general principles physicians should follow to conduct research with humans, based on Nuremberg Code. First effort of medical community to regulate itself When was the Belmont Report released? - ✔✔1979 Who created the Belmont Report? - ✔✔National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (at direction of National Research Act 1974) What are the 3 principles in the Belmont Report? - ✔✔1) Respect for Persons: informed consent required and individuals with diminished autonomy get special protections 2) Beneficence: maximize benefit to research while minimizing risk to subjects 3) Justice: one group of people shouldn't assume risks for the benefit of another (equality and diversity of participants) In what order were historical declarations for human subjects protection released? - ✔✔Nuremberg Code > Declaration of Helsinki > Belmont Report At what reading level should ICFs be written? - ✔✔6th-8th grade What FDA guideline lists the basic elements of informed consent? - ✔✔21 CFR 50 (50.25) What are the additional elements of informed consent per FDA guidelines? (7) - ✔✔1) Statement that treatment may involve unforseeable risks 2) Circumstances in which subject participation may be terminated 3) Additional costs to subject 4) Consequences of subject's decision to withdraw 5) Statement that new findings will be provided to subject 6) # of subjects in study 7) clinicaltrials.gov statement (as applicable)
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