SOCRA CCRP EXAMPREP REVIEW SHEET
TESTED QUESTIONS AND ACCURATE
ANSWERS
●● Quality
Answer: ICH Q
●● Efficacy
Answer: ICH E
●● Safety
Answer: ICH S
●● Multidisciplinary
Answer: ICH M
●● guidance for industry, consolidated guideance
Answer: ICH E 6
●● Clinical Safety Data Management Definitions and Standards
Answer: ICH E2A
,●● Safety pharmacology studies for human pharmaceuticals
Answer: ICH S7A
●● Electronic records, electronic signatures
Answer: 21 CFR Part 11
●● Informed Consent
Answer: 21 CFR Part 50
●● Financial Disclosures
Answer: 21 CFR Part 54
●● Institutional Review Board
Answer: 21 CFR Part 56
●● IND Application
Answer: 21 CFR 312
●● New Drug Application
Answer: 21 CFR 314
,●● Investigational Device Exemption
Answer: 21 CFR 812
●● 21 CFR Part 814
Answer: pre market approval of medical devices
●● 45 CFR Part 46
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
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
Answer: Drug Development Safety Pharmacology Study Objectives (3)
●● 1) Cardiovascular
, 2)Respiratory
3)CNS
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
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
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
Answer: Secondary Pharmacodynamic Studies
●● Blood Pressure
TESTED QUESTIONS AND ACCURATE
ANSWERS
●● Quality
Answer: ICH Q
●● Efficacy
Answer: ICH E
●● Safety
Answer: ICH S
●● Multidisciplinary
Answer: ICH M
●● guidance for industry, consolidated guideance
Answer: ICH E 6
●● Clinical Safety Data Management Definitions and Standards
Answer: ICH E2A
,●● Safety pharmacology studies for human pharmaceuticals
Answer: ICH S7A
●● Electronic records, electronic signatures
Answer: 21 CFR Part 11
●● Informed Consent
Answer: 21 CFR Part 50
●● Financial Disclosures
Answer: 21 CFR Part 54
●● Institutional Review Board
Answer: 21 CFR Part 56
●● IND Application
Answer: 21 CFR 312
●● New Drug Application
Answer: 21 CFR 314
,●● Investigational Device Exemption
Answer: 21 CFR 812
●● 21 CFR Part 814
Answer: pre market approval of medical devices
●● 45 CFR Part 46
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
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
Answer: Drug Development Safety Pharmacology Study Objectives (3)
●● 1) Cardiovascular
, 2)Respiratory
3)CNS
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
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
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
Answer: Secondary Pharmacodynamic Studies
●● Blood Pressure
