CCRP Exam 1 correctly answered graded A+
2024/2025
1). April 30 1996
Ans: ICH GCP Development Date
2). Quality
Ans: ICH Q
3). Efficacy
Ans: ICH E
4). Safety
Ans: ICH S
5). Multidisciplinary
Ans: ICH M
6). Guidance for industry, consolidated guideance
Ans: ICH E 6
7). Clinical safety data management definitions and standards
Ans: ICH E2A
8). Safety pharmacology studies for human pharmaceuticals
Ans: ICH S7A
9). Electronic records, electronic signatures
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, Ans: 21 CFR Part 11
10). Informed consent
Ans: 21 CFR Part 50
11). Financial disclosures
Ans: 21 CFR Part 54
12). Institutional review board
Ans: 21 CFR Part 56
13). Ind application
Ans: 21 CFR 312
14). New drug application
Ans: 21 CFR 314
15). Investigational device exemption
Ans: 21 CFR 812
16). 21 cfr part 814
Ans: pre market approval of medical devices
17). 45 cfr part 46
Ans: Federal Research
18). Studies that investigate the potential undesirable pd effects of a substance on
physiological functions in relation to exposure in the therapeutic range or above
Ans: Safety Pharmacology Studies (Pre-Clinical)
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, 19). 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
Ans: Drug Development Safety Pharmacology Study Objectives (3)
20). 1) cardiovascular
2)respiratory
3)cns
Ans: Three vital organ considered highest priority
21). 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
Ans: Types of Non-Clinical Studies (Animal Trials)
22). Study that investigates the mode of action and/or effects of a drug substance in relation
to its desired therapeutic target
Ans: Primary Pharmacodynamic Studies
23). Studies that investigate the mode of action and/or effects of a drug substance not related
to its desire therapeutic target
Ans: Secondary Pharmacodynamic Studies
24). Blood pressure
heart rate
ecg/ekg
repolarization/conductance abnormalities
Ans: Core Battery for Cardiovascular System
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2024/2025
1). April 30 1996
Ans: ICH GCP Development Date
2). Quality
Ans: ICH Q
3). Efficacy
Ans: ICH E
4). Safety
Ans: ICH S
5). Multidisciplinary
Ans: ICH M
6). Guidance for industry, consolidated guideance
Ans: ICH E 6
7). Clinical safety data management definitions and standards
Ans: ICH E2A
8). Safety pharmacology studies for human pharmaceuticals
Ans: ICH S7A
9). Electronic records, electronic signatures
PaperStoc.com Page 1 of 27
, Ans: 21 CFR Part 11
10). Informed consent
Ans: 21 CFR Part 50
11). Financial disclosures
Ans: 21 CFR Part 54
12). Institutional review board
Ans: 21 CFR Part 56
13). Ind application
Ans: 21 CFR 312
14). New drug application
Ans: 21 CFR 314
15). Investigational device exemption
Ans: 21 CFR 812
16). 21 cfr part 814
Ans: pre market approval of medical devices
17). 45 cfr part 46
Ans: Federal Research
18). Studies that investigate the potential undesirable pd effects of a substance on
physiological functions in relation to exposure in the therapeutic range or above
Ans: Safety Pharmacology Studies (Pre-Clinical)
PaperStoc.com Page 2 of 27
, 19). 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
Ans: Drug Development Safety Pharmacology Study Objectives (3)
20). 1) cardiovascular
2)respiratory
3)cns
Ans: Three vital organ considered highest priority
21). 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
Ans: Types of Non-Clinical Studies (Animal Trials)
22). Study that investigates the mode of action and/or effects of a drug substance in relation
to its desired therapeutic target
Ans: Primary Pharmacodynamic Studies
23). Studies that investigate the mode of action and/or effects of a drug substance not related
to its desire therapeutic target
Ans: Secondary Pharmacodynamic Studies
24). Blood pressure
heart rate
ecg/ekg
repolarization/conductance abnormalities
Ans: Core Battery for Cardiovascular System
PaperStoc.com Page 3 of 27
