CCRP UPDATED ACTUAL Exam Questions and CORRECT Answers
| Guaranteed Success | 100% Correct
Question 1.
Short Form
Correct Answer: A document that states that the elements of informed
consent have been presented orally to and understood by the participant or
the participant's LAR.
Question 2.
4 components of short form
Correct Answer: 1. A short form consent document
2. And oral presentation of the required elements of consent
3. An awesome rob approved written summary of what is to be said
4. A witness must be present
Question 3.
Number of days the Sponsor has to report and SAE to the FDA
Correct Answer: 15 calendar days (IND Safety Report) - FDA Form 3500A or
CIOMS I Form (for foreign suspected adverse reactions)
Question 4.
Medical devices 1572?
Correct Answer: No. Investigator agreement instead.
Question 5.
UADE
Correct Answer: Unexpected Adverse Device Effect. Any serious adverse effect
on health or safety or any life-threatening problem or death caused by, or
associated with, a device, if that effect, problem or death was not previously
identified in nature, severity or degree of incidence in the investigational plan
or application, or any other unanticipated serious problem associated with a
device that relates to the rights, safety or welfare of subjects.
Question 6.
Days the investigator has to report UADE to the sponsor
Correct Answer: 10 working days
• Days the sponsor has to report UADE to FDA and IRB -✓✓10 working days
, Question 7.
Days investigator has to report SAE to sponsor
Correct Answer: Immediately
Question 8.
Categories of Research Involving Children
Correct Answer: 1. Research not involving greater than minimal risk
2. Research involving greater then minimal risk, but may provide direct
benefit to an individual subject - risk is justified by the potential benefit - the
relationship of risk to benefit is at least favorable to any alternative approach
3. Research involving greater than minimal risk with no potential direct
benefit to the individual, but may yield general knowledge - risk represents
minor increases over minimal - intervention is reasonable compared to SOC -
intervention is likely to yield knowledge about the subjects disorder or
condition
4. Research not otherwise approvable but presents opportunity to solve big
problem.
Question 9.
Time period where financial disclosure is needed
Correct Answer: During the course of the study and one year after completion
Question 10.
IRB
Correct Answer: Institutional Review Board means any board, committee, or
other group formally designated by an institution to review, to approve the
initiation of, and to conduct periodic review of, biomedical research involving
human subjects. 21CFR56
Question 11.
Primary Goal of the IRB
Correct Answer: To protect the right and safety of human subjects
Question 12.
IRB Membership
Correct Answer: -At least 5 members -Varying backgrounds -Qualified
members -At least 1 scienfic -At least 1 non-scientfic -At least one not
affliacted with insitution
| Guaranteed Success | 100% Correct
Question 1.
Short Form
Correct Answer: A document that states that the elements of informed
consent have been presented orally to and understood by the participant or
the participant's LAR.
Question 2.
4 components of short form
Correct Answer: 1. A short form consent document
2. And oral presentation of the required elements of consent
3. An awesome rob approved written summary of what is to be said
4. A witness must be present
Question 3.
Number of days the Sponsor has to report and SAE to the FDA
Correct Answer: 15 calendar days (IND Safety Report) - FDA Form 3500A or
CIOMS I Form (for foreign suspected adverse reactions)
Question 4.
Medical devices 1572?
Correct Answer: No. Investigator agreement instead.
Question 5.
UADE
Correct Answer: Unexpected Adverse Device Effect. Any serious adverse effect
on health or safety or any life-threatening problem or death caused by, or
associated with, a device, if that effect, problem or death was not previously
identified in nature, severity or degree of incidence in the investigational plan
or application, or any other unanticipated serious problem associated with a
device that relates to the rights, safety or welfare of subjects.
Question 6.
Days the investigator has to report UADE to the sponsor
Correct Answer: 10 working days
• Days the sponsor has to report UADE to FDA and IRB -✓✓10 working days
, Question 7.
Days investigator has to report SAE to sponsor
Correct Answer: Immediately
Question 8.
Categories of Research Involving Children
Correct Answer: 1. Research not involving greater than minimal risk
2. Research involving greater then minimal risk, but may provide direct
benefit to an individual subject - risk is justified by the potential benefit - the
relationship of risk to benefit is at least favorable to any alternative approach
3. Research involving greater than minimal risk with no potential direct
benefit to the individual, but may yield general knowledge - risk represents
minor increases over minimal - intervention is reasonable compared to SOC -
intervention is likely to yield knowledge about the subjects disorder or
condition
4. Research not otherwise approvable but presents opportunity to solve big
problem.
Question 9.
Time period where financial disclosure is needed
Correct Answer: During the course of the study and one year after completion
Question 10.
IRB
Correct Answer: Institutional Review Board means any board, committee, or
other group formally designated by an institution to review, to approve the
initiation of, and to conduct periodic review of, biomedical research involving
human subjects. 21CFR56
Question 11.
Primary Goal of the IRB
Correct Answer: To protect the right and safety of human subjects
Question 12.
IRB Membership
Correct Answer: -At least 5 members -Varying backgrounds -Qualified
members -At least 1 scienfic -At least 1 non-scientfic -At least one not
affliacted with insitution
