SOCRA CCRP Exam
,April 30 1996 - CORRECT ANSWERS-ICH GCP Development Date
Quality - CORRECT ANSWERS-ICH Q
Efficacy - CORRECT ANSWERS-ICH E
Safety - CORRECT ANSWERS-ICH S
Multidisciplinary - CORRECT ANSWERS-ICH M
guidance for industry, consolidated guideance - CORRECT ANSWERS-ICH E 6
Clinical Safety Data Management Definitions and Standards - CORRECT ANSWERS-
ICH E2A
Safety pharmacology studies for human pharmaceuticals - CORRECT ANSWERS-ICH
S7A
Electronic records, electronic signatures - CORRECT ANSWERS-21 CFR Part 11
Informed Consent - CORRECT ANSWERS-21 CFR Part 50
Financial Disclosures - CORRECT ANSWERS-21 CFR Part 54
Institutional Review Board - CORRECT ANSWERS-21 CFR Part 56
IND Application - CORRECT ANSWERS-21 CFR 312
New Drug Application - CORRECT ANSWERS-21 CFR 314
Investigational Device Exemption - CORRECT ANSWERS-21 CFR 812
21 CFR Part 814 - CORRECT ANSWERS-pre market approval of medical devices
45 CFR Part 46 - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-Drug Development Safety Pharmacology Study Objectives (3)
, 1) Cardiovascular
2)Respiratory
3)CNS - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-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 ANSWERS-Secondary
Pharmacodynamic Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - CORRECT ANSWERS-Core Battery for
Cardiovascular System
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - CORRECT
ANSWERS-Core Battery for Respiratory System
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - CORRECT ANSWERS-Core Battery for Central Nervous System
Investigational New Drug Application
FDA - CORRECT ANSWERS-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 - CORRECT ANSWERS-An IND permits what? (21 CFR Part 312)
,April 30 1996 - CORRECT ANSWERS-ICH GCP Development Date
Quality - CORRECT ANSWERS-ICH Q
Efficacy - CORRECT ANSWERS-ICH E
Safety - CORRECT ANSWERS-ICH S
Multidisciplinary - CORRECT ANSWERS-ICH M
guidance for industry, consolidated guideance - CORRECT ANSWERS-ICH E 6
Clinical Safety Data Management Definitions and Standards - CORRECT ANSWERS-
ICH E2A
Safety pharmacology studies for human pharmaceuticals - CORRECT ANSWERS-ICH
S7A
Electronic records, electronic signatures - CORRECT ANSWERS-21 CFR Part 11
Informed Consent - CORRECT ANSWERS-21 CFR Part 50
Financial Disclosures - CORRECT ANSWERS-21 CFR Part 54
Institutional Review Board - CORRECT ANSWERS-21 CFR Part 56
IND Application - CORRECT ANSWERS-21 CFR 312
New Drug Application - CORRECT ANSWERS-21 CFR 314
Investigational Device Exemption - CORRECT ANSWERS-21 CFR 812
21 CFR Part 814 - CORRECT ANSWERS-pre market approval of medical devices
45 CFR Part 46 - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-Drug Development Safety Pharmacology Study Objectives (3)
, 1) Cardiovascular
2)Respiratory
3)CNS - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-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 ANSWERS-Secondary
Pharmacodynamic Studies
Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities - CORRECT ANSWERS-Core Battery for
Cardiovascular System
Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation) - CORRECT
ANSWERS-Core Battery for Respiratory System
Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature - CORRECT ANSWERS-Core Battery for Central Nervous System
Investigational New Drug Application
FDA - CORRECT ANSWERS-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 - CORRECT ANSWERS-An IND permits what? (21 CFR Part 312)
