SOCRA CCRP EXAM NEWEST 2025 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES /SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND
CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
April 30 1996 - ANSWER-ICH GCP Development Date
Quality - ANSWER-ICH Q
Efficacy - ANSWER-ICH E
Safety - ANSWER-ICH S
Multidisciplinary - ANSWER-ICH M
guidance for industry, consolidated guideance - ANSWER-ICH E 6
Clinical Safety Data Management Definitions and Standards - ANSWER-ICH E2A
Safety pharmacology studies for human pharmaceuticals - ANSWER-ICH S7A
Electronic records, electronic signatures - ANSWER-21 CFR Part 11
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
4) Phase of development - ANSWER-IND information depends on the amount of information
available, these 4 things are: (21 CFR Part 312)
General Investigational Plan
Protocols for specific human studies - ANSWER-Initial IND should focus on (21 CFR Part 312)
Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies -
ANSWER-Amendments to IND with new or revised protocols (21 CFR Part 312)
Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
ANSWERS WITH RATIONALES /SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND
CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE
April 30 1996 - ANSWER-ICH GCP Development Date
Quality - ANSWER-ICH Q
Efficacy - ANSWER-ICH E
Safety - ANSWER-ICH S
Multidisciplinary - ANSWER-ICH M
guidance for industry, consolidated guideance - ANSWER-ICH E 6
Clinical Safety Data Management Definitions and Standards - ANSWER-ICH E2A
Safety pharmacology studies for human pharmaceuticals - ANSWER-ICH S7A
Electronic records, electronic signatures - ANSWER-21 CFR Part 11
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
4) Phase of development - ANSWER-IND information depends on the amount of information
available, these 4 things are: (21 CFR Part 312)
General Investigational Plan
Protocols for specific human studies - ANSWER-Initial IND should focus on (21 CFR Part 312)
Build logically on previous submissions
Be supported by additional information such as animal studies and other human studies -
ANSWER-Amendments to IND with new or revised protocols (21 CFR Part 312)
Cover Sheet (FDA Form 1571)
Table of Contents
Introductory statement
investigator's brochure
