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Socra-CCRP-EXAM-WITH 100% CORRECT ANSWERS

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Contract Research Organization A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. ... When a short form is used for informed consent the witness must sign the short form or the summary? False-they must sign both What is FDA form 3454 Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the Belmont Report? Respect for persons. Beneficence. Justice. Phase III Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1 to 4 years Purpose: Efficacy and monitoring of adverse reactions Phase I 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Phase II Study Participants: Up to several hundred people with the disease/condition. Length of Study: Several months to 2 years Purpose: Efficacy and side effects The main concept of 21 CFR 50 is protection of human subjects 21 CFR 50 part D protection of childern A____________ can be any unfavorable and unintended sign) including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. adverse event The FDA form 483 is used for _______ Inspectional oberservation The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as GCP [Show More]

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