CCRP Exam Questions and Answers
(2026) | Guaranteed Success | 100%
Correct
• Short Form -✓✓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.
• 4 components of short form -✓✓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
• Number of days the Sponsor has to report and SAE to the FDA -✓✓15
calendar days (IND Safety Report) - FDA Form 3500A or CIOMS I
Form (for foreign suspected adverse reactions)
• Medical devices 1572? -✓✓No. Investigator agreement instead.
• UADE -✓✓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.
• Days the investigator has to report UADE to the sponsor -✓✓10
working days
, • Days the sponsor has to report UADE to FDA and IRB -✓✓10
working days
• Days investigator has to report SAE to sponsor -✓✓Immediately
• Categories of Research Involving Children -✓✓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.
• Time period where financial disclosure is needed -✓✓During the
course of the study and one year after completion
• IRB -✓✓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
• Primary Goal of the IRB -✓✓To protect the right and safety of human
subjects
• IRB Membership -✓✓-At least 5 members
-Varying backgrounds
(2026) | Guaranteed Success | 100%
Correct
• Short Form -✓✓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.
• 4 components of short form -✓✓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
• Number of days the Sponsor has to report and SAE to the FDA -✓✓15
calendar days (IND Safety Report) - FDA Form 3500A or CIOMS I
Form (for foreign suspected adverse reactions)
• Medical devices 1572? -✓✓No. Investigator agreement instead.
• UADE -✓✓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.
• Days the investigator has to report UADE to the sponsor -✓✓10
working days
, • Days the sponsor has to report UADE to FDA and IRB -✓✓10
working days
• Days investigator has to report SAE to sponsor -✓✓Immediately
• Categories of Research Involving Children -✓✓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.
• Time period where financial disclosure is needed -✓✓During the
course of the study and one year after completion
• IRB -✓✓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
• Primary Goal of the IRB -✓✓To protect the right and safety of human
subjects
• IRB Membership -✓✓-At least 5 members
-Varying backgrounds
