CCRP Exam with Questions and
Answers/100% Correct/ Grade A+
Year/ description of the Nuremberg Code - ✔✔1947- German physicians conducted
unethical experiments on concentration camp prisoners without their consent.
What implications came of the Nuremberg Code? - ✔✔Ten elements of human research
including voluntary informed consent is absolutely essential.
Year and description of the Declaration of Helsinki - ✔✔1964- Based on the principles of the
Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First
significant effort of the medical community to regulate itself. Set the stage for regulating
bodies/IRBs.
Year and description of the Belmont report - ✔✔1974- set the three core standard principles
for all human research for the world
What are the three core principles of the Belmont Report? - ✔✔1)respect for persons-
individuals are autonomous.
- special protections for vulnerable subjects
-informed consent
,2)beneficence-do no harm.
-goal of minimizing risk while maximizing benefits
3)justice-equality in subject selection
-one group can't have all the benefits while another assumes all the risks
What grade level should an informed consent be written? - ✔✔Sixth to eighth
What are the basic elements of informed consent? - ✔✔Reese's Really Bad Actions led to
3Cs and a Vinerial disease
R- research (purpose, duration, procedures)
R- Risks
B- benefits
A- Alternative procedures
C- confidentiality (FDA may inspect)
C- compensation
C- contact
V- voluntary
,What are the additional elements of informed consent - ✔✔ACUPNN
A- additional costs
C- consequences of a subject withdrawal
U- unforeseen risks
P- PI may terminate
N- new findings
N- number of subjects
Clinical trials started after what date needed to include www.clinicaltrials.gov in consent? -
✔✔March 7, 2012
Who is responsible for informed consent form review and approval? - ✔✔IRB
Who has the final authority to approve/ disprove a consent form? - ✔✔IRB
What are the four components needed for consent with a short form? - ✔✔SOWW
S-short form
, O- oral presentation
W- written summary
W- witness
Who signs what in a short form consent? Who gets a copy? - ✔✔Everyone signs what is in
their language
Short Form- subject and witness
Written summary- witness and person obtaining consent
Copies of short form and written summary are given to subject
What are the five things a CRA should look for when reviewing an informed consent form? -
✔✔1) subject signed the most recent IRB approved version
2) signature and printed name present
3) subject signed correct date
4) error was corrected by drawing a single line through error
5) All pages are present
Answers/100% Correct/ Grade A+
Year/ description of the Nuremberg Code - ✔✔1947- German physicians conducted
unethical experiments on concentration camp prisoners without their consent.
What implications came of the Nuremberg Code? - ✔✔Ten elements of human research
including voluntary informed consent is absolutely essential.
Year and description of the Declaration of Helsinki - ✔✔1964- Based on the principles of the
Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First
significant effort of the medical community to regulate itself. Set the stage for regulating
bodies/IRBs.
Year and description of the Belmont report - ✔✔1974- set the three core standard principles
for all human research for the world
What are the three core principles of the Belmont Report? - ✔✔1)respect for persons-
individuals are autonomous.
- special protections for vulnerable subjects
-informed consent
,2)beneficence-do no harm.
-goal of minimizing risk while maximizing benefits
3)justice-equality in subject selection
-one group can't have all the benefits while another assumes all the risks
What grade level should an informed consent be written? - ✔✔Sixth to eighth
What are the basic elements of informed consent? - ✔✔Reese's Really Bad Actions led to
3Cs and a Vinerial disease
R- research (purpose, duration, procedures)
R- Risks
B- benefits
A- Alternative procedures
C- confidentiality (FDA may inspect)
C- compensation
C- contact
V- voluntary
,What are the additional elements of informed consent - ✔✔ACUPNN
A- additional costs
C- consequences of a subject withdrawal
U- unforeseen risks
P- PI may terminate
N- new findings
N- number of subjects
Clinical trials started after what date needed to include www.clinicaltrials.gov in consent? -
✔✔March 7, 2012
Who is responsible for informed consent form review and approval? - ✔✔IRB
Who has the final authority to approve/ disprove a consent form? - ✔✔IRB
What are the four components needed for consent with a short form? - ✔✔SOWW
S-short form
, O- oral presentation
W- written summary
W- witness
Who signs what in a short form consent? Who gets a copy? - ✔✔Everyone signs what is in
their language
Short Form- subject and witness
Written summary- witness and person obtaining consent
Copies of short form and written summary are given to subject
What are the five things a CRA should look for when reviewing an informed consent form? -
✔✔1) subject signed the most recent IRB approved version
2) signature and printed name present
3) subject signed correct date
4) error was corrected by drawing a single line through error
5) All pages are present
