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CCRP (CERTIFIED CLINICAL RESEARCH PROFESSIONAL)
EXAM 2025 QUESTIONS AND ANSWERS
What type of controls are Class I devices subject to? - correct answer - General
controls: basic rules regulating adulteration, misbranding, device registration
and listing, PMN, banned devices, notification (repair, replacement or refund),
records/reports, restrictions and GMP
What type of controls are Class II devices subject to? - correct answer - General
controls + special controls: special labeling, mandatory performance standards,
post market surveillance, FDA medical device specific guidance
What type of controls are Class III devices subject to? - correct answer -
General controls + premarket approval via Premarket Approval Application
What are some examples of Class I devices? - correct answer - Bandages,
gloves, depressors, arm slings, and other devices posing little harm
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What are some examples of Class II devices? - correct answer - Physiologic
monitors, X-ray machines, infusion pumps, acupuncture needles and powered
wheelchairs (greater potential risk)
What FDA notification requirement does a Class II device have? - correct answer
- FDA 510(k) clearance - notify FDA 90 days prior to marketing as a pre-
market notification; FDA then determines if device is equivalent to previously
approved devices and allows it to be sold
What risk level do Class III devices pose? - correct answer - Support or sustain
human life, therefore present significant risk to illness and injury
What is necessary for submission of a Premarket Approval Application? -
correct answer - Clinical trials in humans needed to show safety and
effectiveness
What are the phases of device trials? - correct answer - 1) Pilot
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2) Pivotal
What does an investigator attest to when signing an Investigator's Agreement?
(3) - correct answer - Qualification
Commitment to conduct study following regulations Supervision of trial
How is treatment cost different between drug and device trials? - correct
answer - Drug: provided to investigators for clinical trial use
Device: investigators charged for devices and reimbursed by insurance or
government plan
What is the difference in AE reporting between drug and device trials? - correct
answer - Drug: all AEs are recorded and evaluated for drug relationship
Device: due to local effect, not all AEs may need to be collected or evaluated
What is an in-vtiro diagnostic? - correct answer - Way to test for a certain
property or result outside the human body
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What FDA regulations define in-vitro diagnostics? - correct answer - 21
CFR 809.3(a)
IVD studies don't need informed consent if they meet what 6 criteria? -
correct answer - 1) If IDE submission unnecessary (NSR or exempt)
2) Leftover specimens used
3) Specimens not individually identifiable
4) Individual caring for patients is different from those conducting trial
5) Specimens provided to investigator without identifiers
6) Clinical trial overseen by IRB
What is the FDA monitoring program? - correct answer - Bioresearch
Monitoring program (BIMO)
What are the 3 goals of the BIMO program? - correct answer - 1) Protect rights,
safety and welfare of subject involved in FDA- regulated trials
CCRP (CERTIFIED CLINICAL RESEARCH PROFESSIONAL)
EXAM 2025 QUESTIONS AND ANSWERS
What type of controls are Class I devices subject to? - correct answer - General
controls: basic rules regulating adulteration, misbranding, device registration
and listing, PMN, banned devices, notification (repair, replacement or refund),
records/reports, restrictions and GMP
What type of controls are Class II devices subject to? - correct answer - General
controls + special controls: special labeling, mandatory performance standards,
post market surveillance, FDA medical device specific guidance
What type of controls are Class III devices subject to? - correct answer -
General controls + premarket approval via Premarket Approval Application
What are some examples of Class I devices? - correct answer - Bandages,
gloves, depressors, arm slings, and other devices posing little harm
, Page | 2
What are some examples of Class II devices? - correct answer - Physiologic
monitors, X-ray machines, infusion pumps, acupuncture needles and powered
wheelchairs (greater potential risk)
What FDA notification requirement does a Class II device have? - correct answer
- FDA 510(k) clearance - notify FDA 90 days prior to marketing as a pre-
market notification; FDA then determines if device is equivalent to previously
approved devices and allows it to be sold
What risk level do Class III devices pose? - correct answer - Support or sustain
human life, therefore present significant risk to illness and injury
What is necessary for submission of a Premarket Approval Application? -
correct answer - Clinical trials in humans needed to show safety and
effectiveness
What are the phases of device trials? - correct answer - 1) Pilot
, Page | 3
2) Pivotal
What does an investigator attest to when signing an Investigator's Agreement?
(3) - correct answer - Qualification
Commitment to conduct study following regulations Supervision of trial
How is treatment cost different between drug and device trials? - correct
answer - Drug: provided to investigators for clinical trial use
Device: investigators charged for devices and reimbursed by insurance or
government plan
What is the difference in AE reporting between drug and device trials? - correct
answer - Drug: all AEs are recorded and evaluated for drug relationship
Device: due to local effect, not all AEs may need to be collected or evaluated
What is an in-vtiro diagnostic? - correct answer - Way to test for a certain
property or result outside the human body
, Page | 4
What FDA regulations define in-vitro diagnostics? - correct answer - 21
CFR 809.3(a)
IVD studies don't need informed consent if they meet what 6 criteria? -
correct answer - 1) If IDE submission unnecessary (NSR or exempt)
2) Leftover specimens used
3) Specimens not individually identifiable
4) Individual caring for patients is different from those conducting trial
5) Specimens provided to investigator without identifiers
6) Clinical trial overseen by IRB
What is the FDA monitoring program? - correct answer - Bioresearch
Monitoring program (BIMO)
What are the 3 goals of the BIMO program? - correct answer - 1) Protect rights,
safety and welfare of subject involved in FDA- regulated trials
