CCRP Exam with Questions and
Answers/100% Correct/ Grade A+
SAE - ✔✔Serious Adverse Event:
- results in death
- is life threatening (patient was at risk of death at time of the event)
- results in persistent or significant disability
- congenital anomaly/birth defect
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
-Qualified members
-At least 1 scienfic
Answers/100% Correct/ Grade A+
SAE - ✔✔Serious Adverse Event:
- results in death
- is life threatening (patient was at risk of death at time of the event)
- results in persistent or significant disability
- congenital anomaly/birth defect
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
-Qualified members
-At least 1 scienfic
