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CCRP Exam Questions and Answers With Complete Solution
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CCRP Exam Questions and AnswersWith Complete Solution
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)
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
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
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