Socra CCRP Exam Questions And Answers 100% Accurate

Contract Research Organization - ANSWER-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? - ANSWER-False-they must sign both What is FDA form 3454 - ANSWER-Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the Belmont Report? - ANSWER-Respect for persons. Beneficence. Justice. Phase III - ANSWER-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 - ANSWER-20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months