Socra CCRP questions and answers 2023.

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. -answerContract Research Organization False-they must sign both -answerWhen a short form is used for informed consent the witness must sign the short form or the summary? Certification Financial Interests and Arrangements of Clinical Investigators -answerWhat is FDA form 3454 Respect for persons. Beneficence. Justice. -answerWhat are the three main basic ethical principles of the Belmont Report? 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 -answerPhase III 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage -answerPhase I Study Participants: Up to several hundred people with the disease/condition. Length of Study