SOCRA CCRP Exam 2025: Newest Test Bank & Practice Exam | Certified Clinical Research Professional

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SOCRA CCRP EXAM AND PRACTICE EXAM NEWEST

2025 TEST BANK| COMPLETE 550 REAL EXAM

QUESTIONS AND CORRECT DETAILED ANSWERS

(VERIFIED ANSWERS) GRADED A+| SOCRA CCRP

ACTUAL EXAM PREP 2025 (MOST RECENT!!)

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

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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

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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

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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