Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a medicinal product related to any dose
E6(R1) 1 Correct Answer: Glossary of terms
Adverse Event (AE) Correct Answer: Any untow
...
Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a medicinal product related to any dose
E6(R1) 1 Correct Answer: Glossary of terms
Adverse Event (AE) Correct Answer: 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--any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product
Applicable Regulatory Requirements Correct Answer: Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products
Institutional Review Board Approval Correct Answer: The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements
Audit Correct Answer: A 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 Clinical Practice (GCP), and the applicable regulatory requirement(s)
Audit Certificate Correct Answer: A declaration of confirmation by the auditor that an audit has taken place
Audit Report Correct Answer: A written evaluation by the sponsor's auditor of the results of the audit
Audit Trail Correct Answer: Documentation that allows reconstruction of the course of events
Blinding/Masking Correct Answer: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
Case Report Form (CRF) Correct Answer: 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.
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