SOCRA CCRP EXAM | QUESTIONS AND ANSWERS | EXAM
ALREADY GRADED A+ | LATEST EXAM UPDATE
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
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - CORRECT
ANSWER - Core Battery for Respiratory System
Motor activity
ALREADY GRADED A+ | LATEST EXAM UPDATE
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
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - CORRECT
ANSWER - Core Battery for Respiratory System
Motor activity
