Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Already Passed

Good Clinical Practice Questions and Answers | Latest Update | 2024/2025 | Already Passed Clinical trials are subject to strict guidelines, known as Good Clinical Practice (GCP), which ensures that data is accurate, credible, and reliable. GCP **sets a high standard for the entire clinical trial process**, covering all aspects from design to reporting, to guarantee the integrity of research findings and protect the rights and confidentiality of participants. The primary goal of GCP is **to establish a unified standard across multiple jurisdictions**, allowing regulatory authorities in the European Union, Japan, and the US to recognize and accept clinical data without duplication or unnecessary delays. An Adverse Drug Reaction (ADR) is a type of unwanted response to a medicinal product, which can be **noxious or harmful** in nature. An ADR is considered to have a causal relationship with the medicinal product if there is at least a reasonable possibility that the product caused the adverse event. ADRs occur when a medicinal product is used for therapeutic purposes, such as treating a disease or modifying physiological functions. In this context, an Adverse Drug Reaction (ADR) is characterized by an unacceptable response to a marketed medicinal product that was **intended for use in humans**. An Adverse Event (AE) is any unfavorable and unintended sign, symptom, or disease that arises during the use of an investigational medicinal product. AEs can be related or unrelated to the product and are typically reported during clinical trials to monitor safety and efficacy. Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) Any untoward medical occurrence that at any dose: - results in death, - is life-threatening, - requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or - is a congenital anomaly/birth defect Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information Audit systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good