ICH Harmonized Guideline for Good Clinical Practice E6 Questions and Answers | Latest Version | 2024/2025 | Rated A+

ICH Harmonized Guideline for Good Clinical Practice E6 Questions and Answers | Latest Version | 2024/2025 | Rated A+ Good Clinical Practice (GCP) is a globally recognized standard for ensuring the integrity of clinical trials, encompassing ethical and scientific principles for designing, conducting, recording, and reporting studies involving human subjects. The foundation of GCP lies in the **Declaration of Helsinki**, a cornerstone of modern medical ethics. GCP is adopted as a unified standard by numerous countries, including the European Union, Japan, the United States, Australia, Canada, the Nordic countries, and the World Health Organization. An Adverse Drug Reaction (ADR) is characterized by all noxious and unintended responses to a medicinal product, regardless of dose. A causal relationship must be considered possible, meaning it cannot be ruled out. An Adverse Event (AE) is any unfavorable medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, even if it's not necessarily related to the treatment. Audits are systematic and independent examinations of trial-related activities and documents to verify that the trial was conducted according to the protocol, sponsor's standard operating procedures (SOPs), GCP, and applicable regulatory requirements. The outcome of an audit is documented in an **Audit Certificate**, which serves as confirmation that the audit took place. An **Audit Report** provides a written evaluation of the audit results. The audit trail is the documentation that enables reconstruction of events. Blinding or masking is a procedure where one or more parties to the trial are kept unaware of treatment assignments. There are different types of blinding: single-blinding refers to only the subject being unaware, while double-blinding involves multiple parties, including the investigator(s), monitor, and sometimes data analyst, being unaware of treatment assignments. Case report form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. Clinical trial/study Any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and