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CCRP Exam Questions Bank | 273 Questions with 100% Correct Answers 2024/25 update
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CCRP Exam Questions Bank | 273 Questions with 100%Correct Answers 2024/25 update
How many days does a sponsor have to report an emergency use of an IP to the
FDA? - correct answer 5 working days
How many members must sit on an IRB? - correct answer 5
How long must an IRB retain records per 21 CFR 56? - correct answer 3 years
after completion of research
What are the criteria for IRB approval of research? (7) - correct answer 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? - correct answer 90 days
How many days does an IRB have to inform the FDA that it is reviewing different
types of FDA products? - correct answer 30 days
How often must an IRB renew it's registration? - correct answer 3 years
What are the 8 basic elements of informed consent per FDA guidelines? - correct
answer 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) - correct
answer 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) - correct answer 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
1
,CCRP Exam Questions Bank | 273 Questions with 100%
Correct Answers 2023/24 update
What are the criteria for involving children in greater than minimal risk research
with no direct benefit? (4) - correct answer 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? - correct answer 15 calendar days (21 CFR 312.32)
Investigators must report SAEs to a sponsor within how many days of discovering
the event? - correct answer Immediately (21 CFR 312.64)
Sponsors must report what kind of serious events to the FDA within 15 calendar
days? (4) - correct answer 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 answer 10 working days (21 CFR 812.15)
Investigators must submit Unanticipated Adverse Device Effects to the FDA within
how many days? - correct answer 10 working days (21 CFR 812.15)
When was the Nuremberg Code issued? - correct answer 1947
What are the 10 points made in the Nuremberg Code? - correct answer 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 answer 1964
Who developed the Declaration of Helsinki? - correct answer World Medical
Association (WMA)
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,CCRP Exam Questions Bank | 273 Questions with 100%
Correct Answers 2023/24 update
What is the Declaration of Helsinki? - correct answer 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 answer 1979
Who created the Belmont Report? - correct answer 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 answer 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 answer Nuremberg Code > Declaration of Helsinki > Belmont
Report
At what reading level should ICFs be written? - correct answer 6th-8th grade
What FDA guideline lists the basic elements of informed consent? - correct
answer 21 CFR 50 (50.25)
What are the additional elements of informed consent per FDA guidelines? (7) -
correct answer 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 answer IRB - sponsor can provide
sample form
Describe the 2 most important points to consider when consenting patients (per
21 CFR 50) - correct answer 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
answer 1) Short form consent document stating all elements of ICF have been
presented orally to pt/LAR
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, CCRP Exam Questions Bank | 273 Questions with 100%
Correct Answers 2023/24 update
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 answer 1) 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 answer Subject/LAR signs
long form consent
Do you keep informed consent records for patients who withdraw during study? -
correct answer Yes
CRA should monitor what elements of consent process? (5) - correct answer 1)
Subject signed most recent version of form
2) Subject signature and name are both present
3) Subject dated themselves and date is correct
4) Errors were corrected adequately
5) All pages of ICF are present
What is Source Data Verification? (SDV) - correct answer CRF or other data
collection instruments are compared to original source of information to confirm
data accuracy
What is Source Data Review (SDR) - correct answer Review of source
documentation to check quality, and review and ensure protocol compliance
What is the definition of an adverse event (AE)? - correct answer Sign, symptom,
illness or untoward experience that develops or worsens during a study,
regardless of relation to study treatment
How are AEs documented? - correct answer - In AE CRF for sponsor (or other
study collection mechanism)
- In medical record
What 3 components of AE documentation should CRAs monitor? - correct answer
1) Ensure AEs are recorded in study files and medical record
2) Make sure protocol procedures were followed
3) Check that responsible person assessed AE for seriousness, causality and
expectedness
What is the definition of a serious adverse event (SAE)? (5 possibilities) - correct
answer Any untoward occurrence that results in:
4
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