CCRP Exam 2024 with 100%Correct Answers.

CCRP Exam 2024 with 100%Correct Answers. How many days does a sponsor have to report an emergency use of an IP to the FDA? correct answer5 working days How many members must sit on an IRB? correct answer5 How long must an IRB retain records per 21 CFR 56? correct answer3 years after completion of research What are the criteria for IRB approval of research? (7) correct answer1. 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? correct answer90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? correct answer30 days How often must an IRB renew it's registration? correct answer3 years What are the 8 basic elements of informed consent per FDA guidelines? correct answer1. 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) correct answer1. 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) correct answer1. 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) correct answer1. 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? correct answer15 calendar days (21 CFR 312.32) Investigators must report SAEs to a sponsor within how many days of discovering the event? correct answerImmediately (21 CFR 312.64) Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4) correct answer1) 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? correct answer10 working days (21 CFR 812.15) Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days? correct answer10 working days (21 CFR 812.15) When was the Nuremberg Code issued? correct answer1947 What are the 10 points made in the Nuremberg Code? correct answer1) 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? correct answer1964 Who developed the Declaration of Helsinki? correct answerWorld Medical Association (WMA) What is the Declaration of Helsinki? correct answerDocument 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? correct answer1979 Who created the Belmont Report? correct answerNational 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? correct answer1) 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? correct answerNuremberg Code Declaration of Helsinki Belmont Report At what reading level should ICFs be written? correct answer6th-8th grade What FDA guideline lists the basic elements of informed consent? correct answer21 CFR 50 (50.25) What are the additional elements of informed consent per FDA guidelines? (7) correct answer1) 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) statement (as applicable) Who ultimately approves an ICF? correct answerIRB - sponsor can provide sample form Describe the 2 most important points to consider when consenting patients (per 21 CFR 50) correct answer1) No person can participate without their or LAR consent (50.20) 2) Documentation of informed consent is required (50.27) What are the 4 components of the consent process using a short form? correct answer1) Short form consent document stating all elements of ICF have been presented orally to pt/LAR 2) Oral presentation of required elements 3) IRB-approved summary of what is said 4) Witness present during presentation How do you document short form consent? correct answer1) Subject/LAR signs short form consent 2) Witness signs short form consent and summary 3) Person obtaining consent signs summary - Copy of short form consent and summary are given to subject/LAR How do you document long form consent? correct answerSubject/LAR signs long form consent Do you keep informed consent records for patients who withdraw during study? correct answerYes.