ICH HARMONISED GUIDELINE FOR GOOD
CLINICAL PRACTICE E6 || 60+ QUESTIONS
AND ANSWERS 2025| LATEST UPDATE
Good Clinical Prac- tice
international ethical and scientific quality standard for designing, conducting,
(GCP)
recording, and reporting trials that involve the participation of human subjects
1. What is the origin of Declaration of Helsinki
GCP?
2. Unified Laws of EU, Japan, US, Australia, Canada, the Nordic countries, and the WHO
which countries?
3. adverse drug reac- all noxious and unintended responses to a medicinal product related to any
tion dose should be considered adverse drug reactions. Causal relationship must
be at least a reading possibility i.e. the relationship cannot be ruled out
4. Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment.
5. Audit A systematic and independent examination of trial-related activities and docu-
ments to determine whether the evaluated trial-related activities were conduct-
ed, and the data were recorded, analyzed, and accurately reported according
to the protocol, sponsor's standard operating procedures (SOPs), GCP, and the
applicable regulatory requirements.
6. Audit Certificate A declaration of confirmation by the auditor that an audit has taken place.
7. Audit Report A written evaluation by the sponsor's auditor of the results of the audit.
8. Audit Trail Documentation that allows reconstruction of the course of events.
9. Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment.
, ICH HARMONISED GUIDELINE FOR GOOD
CLINICAL PRACTICE E6 || 60+ QUESTIONS
AND ANSWERS 2025| LATEST UPDATE
10. Single-Blinding refers to the subject(s) being unaware
CLINICAL PRACTICE E6 || 60+ QUESTIONS
AND ANSWERS 2025| LATEST UPDATE
Good Clinical Prac- tice
international ethical and scientific quality standard for designing, conducting,
(GCP)
recording, and reporting trials that involve the participation of human subjects
1. What is the origin of Declaration of Helsinki
GCP?
2. Unified Laws of EU, Japan, US, Australia, Canada, the Nordic countries, and the WHO
which countries?
3. adverse drug reac- all noxious and unintended responses to a medicinal product related to any
tion dose should be considered adverse drug reactions. Causal relationship must
be at least a reading possibility i.e. the relationship cannot be ruled out
4. Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a
causal relationship with this treatment.
5. Audit A systematic and independent examination of trial-related activities and docu-
ments to determine whether the evaluated trial-related activities were conduct-
ed, and the data were recorded, analyzed, and accurately reported according
to the protocol, sponsor's standard operating procedures (SOPs), GCP, and the
applicable regulatory requirements.
6. Audit Certificate A declaration of confirmation by the auditor that an audit has taken place.
7. Audit Report A written evaluation by the sponsor's auditor of the results of the audit.
8. Audit Trail Documentation that allows reconstruction of the course of events.
9. Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the
treatment assignment.
, ICH HARMONISED GUIDELINE FOR GOOD
CLINICAL PRACTICE E6 || 60+ QUESTIONS
AND ANSWERS 2025| LATEST UPDATE
10. Single-Blinding refers to the subject(s) being unaware
