SOCRA CCRP Exam 2026 Questions and
Answers
Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans? - Correct answer-Phase 0 clinical trial
True or false: the federal food, drug, and cosmetic act is United States, federal law
enacted by Congress? - Correct answer-True
True or false: the FD&C act can be found in the US code, which contains all
general in permanent US laws beginning at 21 U.S.C.301? - Correct answer-True
Food, Drug, and Cosmetic Act of 1938 - Correct answer-Requires new drugs must
be proven safe before marketing
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,21 CFR 10.115 what are Guidance documents - Correct answer-Documents
prepared for FTA, staff, applicants, sponsors, and the public that describe the
agencies interpretation or policy and regulatory issues.
Phase 1 clinical trials
Safety phase
Small in #'s
Healthy subjects used
-Is it safe? - Correct answer-Phase 1 clinical trial
Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment - Correct answer-Phase 2 clinical
trial
Phase 3 clinical trials
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,"Pivotal Study"
Larger #'s
Those with the disease
-seeks statistical evidence - Correct answer-Phase 3 clinical trials
Phase 4 clinical trials
"Post market surveillance"
General public
Longer years of data collection
Post regulatory approval
-what are the long term effects - Correct answer-Phase 4 clinical trial
What is 21 CFR 10.115 - Correct answer-The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
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, Pivotal trials (larger #'s)
-No phases only Classes 1-3 - Correct answer-Medical device classifications
Medical device class 1
General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient - Correct answer-Medical device class 1
Medical device class 2
General controls & special controls
Pumps, X-ray machines, monitors, POC devices
May need 501K clearance
*These devices have a moderate to high risk to the patient and/or user. - Correct
answer-Medical device class 2
©COPYRIGHT 2025, ALL RIGHTS RESERVED 4
Answers
Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans? - Correct answer-Phase 0 clinical trial
True or false: the federal food, drug, and cosmetic act is United States, federal law
enacted by Congress? - Correct answer-True
True or false: the FD&C act can be found in the US code, which contains all
general in permanent US laws beginning at 21 U.S.C.301? - Correct answer-True
Food, Drug, and Cosmetic Act of 1938 - Correct answer-Requires new drugs must
be proven safe before marketing
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
,21 CFR 10.115 what are Guidance documents - Correct answer-Documents
prepared for FTA, staff, applicants, sponsors, and the public that describe the
agencies interpretation or policy and regulatory issues.
Phase 1 clinical trials
Safety phase
Small in #'s
Healthy subjects used
-Is it safe? - Correct answer-Phase 1 clinical trial
Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment - Correct answer-Phase 2 clinical
trial
Phase 3 clinical trials
©COPYRIGHT 2025, ALL RIGHTS RESERVED 2
,"Pivotal Study"
Larger #'s
Those with the disease
-seeks statistical evidence - Correct answer-Phase 3 clinical trials
Phase 4 clinical trials
"Post market surveillance"
General public
Longer years of data collection
Post regulatory approval
-what are the long term effects - Correct answer-Phase 4 clinical trial
What is 21 CFR 10.115 - Correct answer-The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
©COPYRIGHT 2025, ALL RIGHTS RESERVED 3
, Pivotal trials (larger #'s)
-No phases only Classes 1-3 - Correct answer-Medical device classifications
Medical device class 1
General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient - Correct answer-Medical device class 1
Medical device class 2
General controls & special controls
Pumps, X-ray machines, monitors, POC devices
May need 501K clearance
*These devices have a moderate to high risk to the patient and/or user. - Correct
answer-Medical device class 2
©COPYRIGHT 2025, ALL RIGHTS RESERVED 4
