9/17/25, 10:41 AM SOCRA CCRP Exam Questions
SOCRA CCRP Certification EXAM 2025/2026 Actual Complete
Real Exam Questions & Correct Well Elaborated Answers
|100% Verified solutions | Already Verified Test | Already
Graded A+ / 2025-2026 Brand New Exam!!
April 30 1996 ICH GCP Development Date
Quality ICH Q
Efficacy ICH E
Safety ICH S
Multidisciplinary ICH M
guidance for industry, ICH E 6
consolidated guideance
Clinical Safety Data ICH E2A
Management Definitions
and Standards
Safety pharmacology studies ICH S7A
for human pharmaceuticals
Electronic records, electronic 21 CFR Part 11
signatures
Informed Consent 21 CFR Part 50
Financial Disclosures 21 CFR Part 54
Institutional Review Board 21 CFR Part 56
IND Application 21 CFR 312
New Drug Application 21 CFR 314
Investigational Device 21 CFR 812
Exemption
21 CFR Part 814 pre market approval of medical devices
45 CFR Part 46 Federal Research
/ 1/27
,9/17/25, 10:49 AM SOCRA CCRP Exa
Studies that investigate the Safety Pharmacology Studies (Pre-Clinical)
potential
undesirable PD effects of a
substance on physiological
functions in relation to
exposure in the therapeutic
range or above
1) To Identify undesirable PD Drug Development Safety Pharmacology Study Objectives (3)
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
1) Cardiova Three vital organ considered highest priority
scular
2)Respira
tory
3)CNS
1) PK and toxicokinetic Types of Non-Clinical Studies (Animal Trials)
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if
needed
Study that investigates the Primary Pharmacodynamic Studies
mode of action and/or
effects of a drug
substance in
relation to its desired
/ 2/27
, 9/17/25, 10:49 AM SOCRA CCRP Exa
therapeutic target
Studies that investigate the Secondary Pharmacodynamic Studies
mode of action and/or
effects of a drug
substance not
related to its desire
therapeutic target
Blood Core Battery for Cardiovascular System
Pressure
Heart Rate
ECG/EKG
Repolarization/conductance
abnormalities
Respiratory Rate Core Battery for Respiratory System
Functional Assessments (tidal
volume, hgb Oxygen
saturation)
Motor activity Core Battery for Central Nervous System
behavioral
changes
coordination
sensory/motor reflex
response temperature
Before clinical trials can be initiated, an application
Investigational New
containing the appropriate information must be
Drug Application FDA
submitted to regulatory authorities, in the USA this is
called XXXX and submitted to the XXX (21 CFR Part
312)
Unapproved drug to be An IND permits what? (21 CFR Part 312)
shipped lawfully for the
purpose of conducting
investigations of the drug
Assuring the safety and rights FDA's primary objective in all phases of development is...
of subjects
/ 3/27
SOCRA CCRP Certification EXAM 2025/2026 Actual Complete
Real Exam Questions & Correct Well Elaborated Answers
|100% Verified solutions | Already Verified Test | Already
Graded A+ / 2025-2026 Brand New Exam!!
April 30 1996 ICH GCP Development Date
Quality ICH Q
Efficacy ICH E
Safety ICH S
Multidisciplinary ICH M
guidance for industry, ICH E 6
consolidated guideance
Clinical Safety Data ICH E2A
Management Definitions
and Standards
Safety pharmacology studies ICH S7A
for human pharmaceuticals
Electronic records, electronic 21 CFR Part 11
signatures
Informed Consent 21 CFR Part 50
Financial Disclosures 21 CFR Part 54
Institutional Review Board 21 CFR Part 56
IND Application 21 CFR 312
New Drug Application 21 CFR 314
Investigational Device 21 CFR 812
Exemption
21 CFR Part 814 pre market approval of medical devices
45 CFR Part 46 Federal Research
/ 1/27
,9/17/25, 10:49 AM SOCRA CCRP Exa
Studies that investigate the Safety Pharmacology Studies (Pre-Clinical)
potential
undesirable PD effects of a
substance on physiological
functions in relation to
exposure in the therapeutic
range or above
1) To Identify undesirable PD Drug Development Safety Pharmacology Study Objectives (3)
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
1) Cardiova Three vital organ considered highest priority
scular
2)Respira
tory
3)CNS
1) PK and toxicokinetic Types of Non-Clinical Studies (Animal Trials)
2) Single dose toxicity
3) Repeated dose toxicity
4) Local tolerance
5) Genotoxicity
6) Carcinogenicity
7) Reproduction toxicity
8) Supplemental studies if
needed
Study that investigates the Primary Pharmacodynamic Studies
mode of action and/or
effects of a drug
substance in
relation to its desired
/ 2/27
, 9/17/25, 10:49 AM SOCRA CCRP Exa
therapeutic target
Studies that investigate the Secondary Pharmacodynamic Studies
mode of action and/or
effects of a drug
substance not
related to its desire
therapeutic target
Blood Core Battery for Cardiovascular System
Pressure
Heart Rate
ECG/EKG
Repolarization/conductance
abnormalities
Respiratory Rate Core Battery for Respiratory System
Functional Assessments (tidal
volume, hgb Oxygen
saturation)
Motor activity Core Battery for Central Nervous System
behavioral
changes
coordination
sensory/motor reflex
response temperature
Before clinical trials can be initiated, an application
Investigational New
containing the appropriate information must be
Drug Application FDA
submitted to regulatory authorities, in the USA this is
called XXXX and submitted to the XXX (21 CFR Part
312)
Unapproved drug to be An IND permits what? (21 CFR Part 312)
shipped lawfully for the
purpose of conducting
investigations of the drug
Assuring the safety and rights FDA's primary objective in all phases of development is...
of subjects
/ 3/27
