1
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SOCRA CCRP Exam Questions and
Answers (100% Correct Answers) Already
Graded A+
April 30 1996 [ ANS: ] ICH GCP Development Date
Quality [ ANS: ] ICH Q
Efficacy [ ANS: ] ICH E
Safety [ ANS: ] ICH S
© 2025 Assignment Expert
Multidisciplinary [ ANS: ] ICH M
guidance for industry, consolidated guideance [ ANS: ] ICH E 6
Guru01 - Stuvia
Clinical Safety Data Management Definitions and Standards [
ANS: ] ICH E2A
Safety pharmacology studies for human pharmaceuticals [ ANS: ]
ICH S7A
Electronic records, electronic signatures [ ANS: ] 21 CFR Part 11
Informed Consent [ ANS: ] 21 CFR Part 50
Financial Disclosures [ ANS: ] 21 CFR Part 54
Institutional Review Board [ ANS: ] 21 CFR Part 56
IND Application [ ANS: ] 21 CFR 312
New Drug Application [ ANS: ] 21 CFR 314
Investigational Device Exemption [ ANS: ] 21 CFR 812
21 CFR Part 814 [ ANS: ] pre market approval of medical devices
45 CFR Part 46 [ ANS: ] Federal Research
, 2
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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)
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
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Pharmacology Study Objectives (3)
1) Cardiovascular
Guru01 - Stuvia
2)Respiratory
3)CNS [ ANS: ] 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 [ ANS: ] 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 [ ANS: ]
Primary Pharmacodynamic Studies
, 3
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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
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities [ ANS: ] Core Battery
for Cardiovascular System
© 2025 Assignment Expert
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) [
ANS: ] Core Battery for Respiratory System
Guru01 - Stuvia
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature [ ANS: ] Core Battery for Central Nervous System
Investigational New Drug Application
FDA [ ANS: ] Before clinical trials can be initiated, an application
containing the appropriate information must be submitted to
regulatory authorities, in the USA this is called XXXX and submitted
to the XXX (21 CFR Part 312)
Unapproved drug to be shipped lawfully for the purpose of
conducting investigations of the drug [ ANS: ] An IND permits
what? (21 CFR Part 312)
Assuring the safety and rights of subjects [ ANS: ] FDA's primary
objective in all phases of development is...
For Expert help and assignment solutions, +254707240657
SOCRA CCRP Exam Questions and
Answers (100% Correct Answers) Already
Graded A+
April 30 1996 [ ANS: ] ICH GCP Development Date
Quality [ ANS: ] ICH Q
Efficacy [ ANS: ] ICH E
Safety [ ANS: ] ICH S
© 2025 Assignment Expert
Multidisciplinary [ ANS: ] ICH M
guidance for industry, consolidated guideance [ ANS: ] ICH E 6
Guru01 - Stuvia
Clinical Safety Data Management Definitions and Standards [
ANS: ] ICH E2A
Safety pharmacology studies for human pharmaceuticals [ ANS: ]
ICH S7A
Electronic records, electronic signatures [ ANS: ] 21 CFR Part 11
Informed Consent [ ANS: ] 21 CFR Part 50
Financial Disclosures [ ANS: ] 21 CFR Part 54
Institutional Review Board [ ANS: ] 21 CFR Part 56
IND Application [ ANS: ] 21 CFR 312
New Drug Application [ ANS: ] 21 CFR 314
Investigational Device Exemption [ ANS: ] 21 CFR 812
21 CFR Part 814 [ ANS: ] pre market approval of medical devices
45 CFR Part 46 [ ANS: ] Federal Research
, 2
For Expert help and assignment solutions, +254707240657
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)
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
© 2025 Assignment Expert
Pharmacology Study Objectives (3)
1) Cardiovascular
Guru01 - Stuvia
2)Respiratory
3)CNS [ ANS: ] 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 [ ANS: ] 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 [ ANS: ]
Primary Pharmacodynamic Studies
, 3
For Expert help and assignment solutions, +254707240657
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
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities [ ANS: ] Core Battery
for Cardiovascular System
© 2025 Assignment Expert
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) [
ANS: ] Core Battery for Respiratory System
Guru01 - Stuvia
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature [ ANS: ] Core Battery for Central Nervous System
Investigational New Drug Application
FDA [ ANS: ] Before clinical trials can be initiated, an application
containing the appropriate information must be submitted to
regulatory authorities, in the USA this is called XXXX and submitted
to the XXX (21 CFR Part 312)
Unapproved drug to be shipped lawfully for the purpose of
conducting investigations of the drug [ ANS: ] An IND permits
what? (21 CFR Part 312)
Assuring the safety and rights of subjects [ ANS: ] FDA's primary
objective in all phases of development is...
