CCRP EXAM ACTUAL TEST PAPER QUESTIONS CORRECT ANSWERS GRADED A PLUS
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
Short Form
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:
4 components of short form
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:
Number of days the Sponsor has to report and SAE to the FDA
Answer:
15 calendar days (IND Safety Report) - FDA Form 3500A or CIOMS I Form (for foreign suspected
adverse reactions)
Question:
Medical devices 1572?
Answer:
No. Investigator agreement instead.
Question:
,UADE
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:
Days the investigator has to report UADE to the sponsor
Answer:
10 working days
Question:
Days the sponsor has to report UADE to FDA and IRB
Answer:
10 working days
Question:
Days investigator has to report SAE to sponsor
Answer:
Immediately
Question:
Categories of Research Involving Children
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:
Time period where financial disclosure is needed
Answer:
During the course of the study and one year after completion
Question:
IRB
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:
Primary Goal of the IRB
Answer:
To protect the right and safety of human subjects
Question:
IRB Membership
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
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
Short Form
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:
4 components of short form
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:
Number of days the Sponsor has to report and SAE to the FDA
Answer:
15 calendar days (IND Safety Report) - FDA Form 3500A or CIOMS I Form (for foreign suspected
adverse reactions)
Question:
Medical devices 1572?
Answer:
No. Investigator agreement instead.
Question:
,UADE
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:
Days the investigator has to report UADE to the sponsor
Answer:
10 working days
Question:
Days the sponsor has to report UADE to FDA and IRB
Answer:
10 working days
Question:
Days investigator has to report SAE to sponsor
Answer:
Immediately
Question:
Categories of Research Involving Children
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:
Time period where financial disclosure is needed
Answer:
During the course of the study and one year after completion
Question:
IRB
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:
Primary Goal of the IRB
Answer:
To protect the right and safety of human subjects
Question:
IRB Membership
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
