{"id":126471,"date":"2023-11-25T08:18:01","date_gmt":"2023-11-25T08:18:01","guid":{"rendered":"https:\/\/learnexams.com\/blog\/?p=126471"},"modified":"2023-11-25T08:18:02","modified_gmt":"2023-11-25T08:18:02","slug":"ccrp-exam-qbank-273-questions-and-answers","status":"publish","type":"post","link":"https:\/\/www.learnexams.com\/blog\/2023\/11\/25\/ccrp-exam-qbank-273-questions-and-answers\/","title":{"rendered":"CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS"},"content":{"rendered":"\n

CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS<\/p>\n\n\n\n

CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS
How many days does a sponsor have to report an emergency use of an IP to the FDA? Correct
Ans \u27a1 5 working days
How many members must sit on an IRB? Correct Ans \u27a1 5
How long must an IRB retain records per 21 CFR 56? Correct Ans \u27a1 3 years after
completion of research
What are the criteria for IRB approval of research? (7) Correct Ans \u27a1 1. Risks to subjects
are minimized<\/p>\n\n\n\n

    \n
  1. Risks are reasonable in relation to anticipated benefits<\/li>\n\n\n\n
  2. Selection of subjects is equitable<\/li>\n\n\n\n
  3. Informed consent will be sought from subjects or LARs<\/li>\n\n\n\n
  4. Informed consent will be documented<\/li>\n\n\n\n
  5. There is adequate provision of monitoring<\/li>\n\n\n\n
  6. 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 Ans \u27a1 90 days
    How many days does an IRB have to inform the FDA that it is reviewing different types of FDA
    products? Correct Ans \u27a1 30 days
    How often must an IRB renew it’s registration? Correct Ans \u27a1 3 years
    What are the 8 basic elements of informed consent per FDA guidelines? Correct Ans \u27a1 1.
    Statement that the study involves research, purpose and expected duration, description of
    experimental procedures<\/li>\n\n\n\n
  7. Description of reasonably foreseeable risks<\/li>\n\n\n\n
  8. Benefits<\/li>\n\n\n\n
  9. Disclosure of alternative procedures or courses of treatment<\/li>\n\n\n\n
  10. Confidentiality measures<\/li>\n\n\n\n
  11. Compensation and treatments available if injury occurs<\/li>\n\n\n\n
  12. contact information<\/li>\n\n\n\n
  13. Participation is voluntary and subject may discontinue at any time
    What are the criteria for involving children in minimal risk research? (2) Correct Ans \u27a1 1.
    No greater than minimal risk<\/li>\n\n\n\n
  14. 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 Ans \u27a1 1. Risks are justified by benefits<\/li>\n\n\n\n
  15. Relation of anticipated benefit is at least as favorable as that presented by alternative
    approaches<\/li>\n\n\n\n
  16. Assent + consent
    What are the criteria for involving children in greater than minimal risk research with no direct
    benefit? (4) Correct Ans \u27a1 1. Risks are minor increase over minimal risk<\/li>\n\n\n\n
  17. Intervention presents experiences that are reasonable commensurate with normal medical and
    living situations<\/li>\n\n\n\n
  18. Intervention is likely to yield generalizable knowledge that is vital<\/li>\n\n\n\n
  19. Assent + consent
    Sponsors must report SAEs to the FDA within how many days of discovering the event?
    Correct Ans \u27a1 15 calendar days (21 CFR 312.32)
    Investigators must report SAEs to a sponsor within how many days of discovering the event?
    Correct Ans \u27a1 Immediately (21 CFR 312.64)
    Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4)
    Correct Ans \u27a1 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?
    Correct Ans \u27a1 10 working days (21 CFR 812.15)
    Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many
    days? Correct Ans \u27a1 10 working days (21 CFR 812.15)
    When was the Nuremberg Code issued? Correct Ans \u27a1 1947
    What are the 10 points made in the Nuremberg Code? Correct Ans \u27a1 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? Correct Ans \u27a1 1964
    Who developed the Declaration of Helsinki? Correct Ans \u27a1 World Medical Association
    (WMA)<\/li>\n<\/ol>\n\n\n\n

    What is the Declaration of Helsinki? Correct Ans \u27a1 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? Correct Ans \u27a1 1979
    Who created the Belmont Report? Correct Ans \u27a1 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? Correct Ans \u27a1 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? Correct
    Ans \u27a1 Nuremberg Code > Declaration of Helsinki > Belmont Report
    At what reading level should ICFs be written? Correct Ans \u27a1 6th-8th grade
    What FDA guideline lists the basic elements of informed consent? Correct Ans \u27a1 21 CFR
    50 (50.25)
    What are the additional elements of informed consent per FDA guidelines? (7) Correct Ans
    \u27a1 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)
    Who ultimately approves an ICF? Correct Ans \u27a1 IRB – sponsor can provide sample form
    Describe the 2 most important points to consider when consenting patients (per 21 CFR 50)
    Correct Ans \u27a1 1) 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 Ans \u27a1 1)
    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
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