SOCRA CERTIFICATION COMPREHENSIVE
TEST PAPER 2026 FULL ANSWERS 100%
VERIFIED GRADED A+
⩥ 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
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities. Answer: Core Battery for
Cardiovascular System
⩥ Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation). Answer:
Core Battery for Respiratory System
⩥ Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature. Answer: Core Battery for Central Nervous System
, ⩥ Investigational New Drug Application
FDA. Answer: 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. Answer: An IND permits what?
(21 CFR Part 312)
⩥ Assuring the safety and rights of subjects. Answer: FDA's primary
objective in all phases of development is...
⩥ Phase II and III. Answer: These phase of trials, the FDA helps assure
the quality of the scientific evaluation is adequate to permit evaluation of
the drugs safety and efficacy (21 CFR Part 312)
⩥ The FDA. Answer: Who determines if Phase II/III studies are likely to
yield data capable of meeting regulatory standards for marketing
approval?
⩥ 1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
TEST PAPER 2026 FULL ANSWERS 100%
VERIFIED GRADED A+
⩥ 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
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities. Answer: Core Battery for
Cardiovascular System
⩥ Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation). Answer:
Core Battery for Respiratory System
⩥ Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature. Answer: Core Battery for Central Nervous System
, ⩥ Investigational New Drug Application
FDA. Answer: 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. Answer: An IND permits what?
(21 CFR Part 312)
⩥ Assuring the safety and rights of subjects. Answer: FDA's primary
objective in all phases of development is...
⩥ Phase II and III. Answer: These phase of trials, the FDA helps assure
the quality of the scientific evaluation is adequate to permit evaluation of
the drugs safety and efficacy (21 CFR Part 312)
⩥ The FDA. Answer: Who determines if Phase II/III studies are likely to
yield data capable of meeting regulatory standards for marketing
approval?
⩥ 1) Novelty of drug
2)Extent the drug has been studied previously
3) Known of suspected risks
