TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
SOCRA CCRP EXAM 2024-2025 ACTUAL EXAM
200 QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES
ICH GCP Development Date - Answer✔️✔️-April 30 1996
ICH Q - Answer✔️✔️-Quality
ICH E - Answer✔️✔️-Efficacy
ICH S - Answer✔️✔️-Safety
ICH M - Answer✔️✔️-Multidisciplinary
ICH E 6 - Answer✔️✔️-guidance for industry, consolidated guideance
ICH E2A - Answer✔️✔️-Clinical Safety Data Management Definitions and Standards
ICH S7A - Answer✔️✔️-Safety pharmacology studies for human pharmaceuticals
21 CFR Part 11 - Answer✔️✔️-Electronic records, electronic signatures
21 CFR Part 50 - Answer✔️✔️-Informed Consent
21 CFR Part 54 - Answer✔️✔️-Financial Disclosures
21 CFR Part 56 - Answer✔️✔️-Institutional Review Board
21 CFR 312 - Answer✔️✔️-IND Application
21 CFR 314 - Answer✔️✔️-New Drug Application
21 CFR 812 - Answer✔️✔️-Investigational Device Exemption
,TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
pre market approval of medical devices - Answer✔️✔️-21 CFR Part 814
Federal Research - Answer✔️✔️-45 CFR Part 46
Safety Pharmacology Studies (Pre-Clinical) - Answer✔️✔️-Studies that investigate the
potential undesirable PD effects of a substance on physiological functions in relation to
exposure in the therapeutic range or above
Drug Development Safety Pharmacology Study Objectives (3) - Answer✔️✔️-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
Three vital organ considered highest priority - Answer✔️✔️-1) Cardiovascular
2)Respiratory
3)CNS
Types of Non-Clinical Studies (Animal Trials) - Answer✔️✔️-1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
, TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
8) Supplemental studies if needed
Primary Pharmacodynamic Studies - Answer✔️✔️-Study that investigates the mode of
action and/or effects of a drug substance in relation to its desired therapeutic target
Secondary Pharmacodynamic Studies - Answer✔️✔️-Studies that investigate the mode
of action and/or effects of a drug substance not related to its desire therapeutic target
Core Battery for Cardiovascular System - Answer✔️✔️-Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities
Core Battery for Respiratory System - Answer✔️✔️-Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation)
Core Battery for Central Nervous System - Answer✔️✔️-Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature
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) - Answer✔️✔️-Investigational New Drug
Application
FDA
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
SOCRA CCRP EXAM 2024-2025 ACTUAL EXAM
200 QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES
ICH GCP Development Date - Answer✔️✔️-April 30 1996
ICH Q - Answer✔️✔️-Quality
ICH E - Answer✔️✔️-Efficacy
ICH S - Answer✔️✔️-Safety
ICH M - Answer✔️✔️-Multidisciplinary
ICH E 6 - Answer✔️✔️-guidance for industry, consolidated guideance
ICH E2A - Answer✔️✔️-Clinical Safety Data Management Definitions and Standards
ICH S7A - Answer✔️✔️-Safety pharmacology studies for human pharmaceuticals
21 CFR Part 11 - Answer✔️✔️-Electronic records, electronic signatures
21 CFR Part 50 - Answer✔️✔️-Informed Consent
21 CFR Part 54 - Answer✔️✔️-Financial Disclosures
21 CFR Part 56 - Answer✔️✔️-Institutional Review Board
21 CFR 312 - Answer✔️✔️-IND Application
21 CFR 314 - Answer✔️✔️-New Drug Application
21 CFR 812 - Answer✔️✔️-Investigational Device Exemption
,TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
pre market approval of medical devices - Answer✔️✔️-21 CFR Part 814
Federal Research - Answer✔️✔️-45 CFR Part 46
Safety Pharmacology Studies (Pre-Clinical) - Answer✔️✔️-Studies that investigate the
potential undesirable PD effects of a substance on physiological functions in relation to
exposure in the therapeutic range or above
Drug Development Safety Pharmacology Study Objectives (3) - Answer✔️✔️-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
Three vital organ considered highest priority - Answer✔️✔️-1) Cardiovascular
2)Respiratory
3)CNS
Types of Non-Clinical Studies (Animal Trials) - Answer✔️✔️-1) PK and toxicokinetic
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
, TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
8) Supplemental studies if needed
Primary Pharmacodynamic Studies - Answer✔️✔️-Study that investigates the mode of
action and/or effects of a drug substance in relation to its desired therapeutic target
Secondary Pharmacodynamic Studies - Answer✔️✔️-Studies that investigate the mode
of action and/or effects of a drug substance not related to its desire therapeutic target
Core Battery for Cardiovascular System - Answer✔️✔️-Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities
Core Battery for Respiratory System - Answer✔️✔️-Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation)
Core Battery for Central Nervous System - Answer✔️✔️-Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature
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) - Answer✔️✔️-Investigational New Drug
Application
FDA
