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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES $10.49   Add to cart

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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES

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SOCRA CCRP EXAM ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES ICH GCP Development Date - Answer️️ -April 30 1996 ICH Q - Answer️️ -Quality ICH E - Answer️️ -Efficacy ICH S - Answer️️ -Safety ICH M - Answer️️ -Multidisciplinary ICH E 6 - Answer�...

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TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
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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

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