SOCRA CCRP Exam verified questions and answers
2026\2027 A+ Grade
April 30 1996
- correct answer ICH GCP Development Date
Quality
- correct answer ICH Q
Efficacy
- correct answer ICH E
Safety
- correct answer ICH S
Multidisciplinary
- correct answer ICH M
guidance for industry, consolidated guideance
- correct answer ICH E 6
Clinical Safety Data Management Definitions and Standards
- correct answer ICH E2A
Safety pharmacology studies for human pharmaceuticals
- correct answer ICH S7A
,Electronic records, electronic signatures
- correct answer 21 CFR Part 11
Informed Consent
- correct answer 21 CFR Part 50
Financial Disclosures
- correct answer 21 CFR Part 54
Institutional Review Board
- correct answer 21 CFR Part 56
IND Application
- correct answer 21 CFR 312
New Drug Application
- correct answer 21 CFR 314
Investigational Device Exemption
- correct answer 21 CFR 812
21 CFR Part 814
- correct answer pre market approval of medical devices
45 CFR Part 46
- correct answer Federal Research
Studies that investigate the potential undesirable PD effects of a substance on physiological functions in
relation to exposure in the therapeutic range or above
- correct answer Safety Pharmacology Studies (Pre-Clinical)
1) To Identify undesirable PD properties of a substance that may have relevance to its human safety.
2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology studies
, 3)to investigate the mechanism of the adverse PD effects observed and/or suspected
- correct answer Drug Development Safety Pharmacology Study Objectives (3)
1) Cardiovascular
2)Respiratory
3)CNS
- correct answer Three vital organ considered highest priority
1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed
- correct answer Types of Non-Clinical Studies (Animal Trials)
Study that investigates the mode of action and/or effects of a drug substance in relation to its desired
therapeutic target
- correct answer Primary Pharmacodynamic Studies
Studies that investigate the mode of action and/or effects of a drug substance not related to its desire
therapeutic target
- correct answer Secondary Pharmacodynamic Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities
- correct answer Core Battery for Cardiovascular System
2026\2027 A+ Grade
April 30 1996
- correct answer ICH GCP Development Date
Quality
- correct answer ICH Q
Efficacy
- correct answer ICH E
Safety
- correct answer ICH S
Multidisciplinary
- correct answer ICH M
guidance for industry, consolidated guideance
- correct answer ICH E 6
Clinical Safety Data Management Definitions and Standards
- correct answer ICH E2A
Safety pharmacology studies for human pharmaceuticals
- correct answer ICH S7A
,Electronic records, electronic signatures
- correct answer 21 CFR Part 11
Informed Consent
- correct answer 21 CFR Part 50
Financial Disclosures
- correct answer 21 CFR Part 54
Institutional Review Board
- correct answer 21 CFR Part 56
IND Application
- correct answer 21 CFR 312
New Drug Application
- correct answer 21 CFR 314
Investigational Device Exemption
- correct answer 21 CFR 812
21 CFR Part 814
- correct answer pre market approval of medical devices
45 CFR Part 46
- correct answer Federal Research
Studies that investigate the potential undesirable PD effects of a substance on physiological functions in
relation to exposure in the therapeutic range or above
- correct answer Safety Pharmacology Studies (Pre-Clinical)
1) To Identify undesirable PD properties of a substance that may have relevance to its human safety.
2) To evaluate adverse PD and/or pathophysio effects of a substance observed in toxicology studies
, 3)to investigate the mechanism of the adverse PD effects observed and/or suspected
- correct answer Drug Development Safety Pharmacology Study Objectives (3)
1) Cardiovascular
2)Respiratory
3)CNS
- correct answer Three vital organ considered highest priority
1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if needed
- correct answer Types of Non-Clinical Studies (Animal Trials)
Study that investigates the mode of action and/or effects of a drug substance in relation to its desired
therapeutic target
- correct answer Primary Pharmacodynamic Studies
Studies that investigate the mode of action and/or effects of a drug substance not related to its desire
therapeutic target
- correct answer Secondary Pharmacodynamic Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities
- correct answer Core Battery for Cardiovascular System
