CCRP FINAL PAPER 2026 ANSWERS
BUNDLED REVIEW GRADED A+
⩥ 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
⩥ 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
⩥ 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
⩥ 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
⩥ Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities. Answer: Core Battery for
Cardiovascular System
⩥ Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation). Answer:
Core Battery for Respiratory System
⩥ Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature. Answer: Core Battery for Central Nervous System
⩥ Investigational New Drug Application
FDA. Answer: Before clinical trials can be initiated, an application
containing the appropriate information must be submitted to regulatory
BUNDLED REVIEW GRADED A+
⩥ 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
⩥ 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
⩥ 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
⩥ 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
⩥ Blood Pressure
Heart Rate
ECG/EKG
Repolarization/conductance abnormalities. Answer: Core Battery for
Cardiovascular System
⩥ Respiratory Rate
Functional Assessments (tidal volume, hgb Oxygen saturation). Answer:
Core Battery for Respiratory System
⩥ Motor activity
behavioral changes
coordination
sensory/motor reflex response
temperature. Answer: Core Battery for Central Nervous System
⩥ Investigational New Drug Application
FDA. Answer: Before clinical trials can be initiated, an application
containing the appropriate information must be submitted to regulatory
