Page 1 of 47
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
,Page 2 of 47
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
,Page 3 of 47
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
, Page 4 of 47
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
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
,Page 2 of 47
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
,Page 3 of 47
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
, Page 4 of 47
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
