Page | 1
CCRP (CERTIFIED CLINICAL RESEARCH
PROFESSIONAL) EXAM 2025| BRAND NEW
ACTUAL EXAM WITH 100% VERIFIED
QUESTIONS AND CORRECT SOLUTIONS|
GUARANTEED VALUE PACK| ACE YOUR
GRADES.
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
, Page | 2
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
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)
, Page | 3
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
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
, Page | 4
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
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)
CCRP (CERTIFIED CLINICAL RESEARCH
PROFESSIONAL) EXAM 2025| BRAND NEW
ACTUAL EXAM WITH 100% VERIFIED
QUESTIONS AND CORRECT SOLUTIONS|
GUARANTEED VALUE PACK| ACE YOUR
GRADES.
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
, Page | 2
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
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)
, Page | 3
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
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
, Page | 4
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
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)
