ICH GCP GUIDELINES EXAM
QUESTIONS WITH 100% CORRECT
ANSWERS LATEST VERSION 2025/2026.
GCP (Good Clinical Practice) - ANS International ethical and scientific quality standards for the
design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials that involve the participation of human subjects.
- Public assurance that the data and reported results are credible and accurate.
- Rights, safety, well-being, integrity, and confidentiality of trial human subjects are protected.
- Unified standard.
- Mutual acceptance of clinical data.
Adverse Drug Reaction (ADR)
- Pre-approval / new medicinal product / new usages - ANS All noxious and unintended
responses to a medicinal product related to any dose.
- Causal relationship between a medicinal product and an adverse event is at least a reasonable
possibility.
Adverse Drug Reaction (ADR)
- Marketed medicinal products - ANS - Response to a drug which is noxious and unintended.
- Occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function.
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, - Causal relationship between a medicinal product and an adverse event is at least a reasonable
possibility.
Adverse Event (AE) - ANS - Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product.
- Does not necessarily have a causal relationship with this treatment.
- Any unfavourable and unintended sign, symptom, or disease temporally associated with the
use of a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product.
Applicable Regulatory Requirement(s) - ANS Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products.
Approval (Institutional Review Boards (IRB)) - ANS Affirmative decision of the IRB that the
clinical trial has been reviewed and ma be conducted at the institution site within the
constraints set fort by the IRB, the institution, GCP, and the applicable regulatory requirements.
Audit - ANS Systematic and independent examination of trial related activities and
documents to determine whether the evaluated trial related activities were conducted, and the
data recorded, analysed and accurately reported according to the protocol, sponsor's standard
operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).
Audit Certificate - ANS A declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANS A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail - ANS Documentation that allows reconstruction of the course of events.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
QUESTIONS WITH 100% CORRECT
ANSWERS LATEST VERSION 2025/2026.
GCP (Good Clinical Practice) - ANS International ethical and scientific quality standards for the
design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of
clinical trials that involve the participation of human subjects.
- Public assurance that the data and reported results are credible and accurate.
- Rights, safety, well-being, integrity, and confidentiality of trial human subjects are protected.
- Unified standard.
- Mutual acceptance of clinical data.
Adverse Drug Reaction (ADR)
- Pre-approval / new medicinal product / new usages - ANS All noxious and unintended
responses to a medicinal product related to any dose.
- Causal relationship between a medicinal product and an adverse event is at least a reasonable
possibility.
Adverse Drug Reaction (ADR)
- Marketed medicinal products - ANS - Response to a drug which is noxious and unintended.
- Occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function.
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, - Causal relationship between a medicinal product and an adverse event is at least a reasonable
possibility.
Adverse Event (AE) - ANS - Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product.
- Does not necessarily have a causal relationship with this treatment.
- Any unfavourable and unintended sign, symptom, or disease temporally associated with the
use of a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product.
Applicable Regulatory Requirement(s) - ANS Any law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products.
Approval (Institutional Review Boards (IRB)) - ANS Affirmative decision of the IRB that the
clinical trial has been reviewed and ma be conducted at the institution site within the
constraints set fort by the IRB, the institution, GCP, and the applicable regulatory requirements.
Audit - ANS Systematic and independent examination of trial related activities and
documents to determine whether the evaluated trial related activities were conducted, and the
data recorded, analysed and accurately reported according to the protocol, sponsor's standard
operating procedures (SOPs), GCP, and the applicable regulatory requirement(s).
Audit Certificate - ANS A declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANS A written evaluation by the sponsor's auditor of the results of the audit.
Audit Trail - ANS Documentation that allows reconstruction of the course of events.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
