Study guides, Class notes & Summaries

SOCRA CCRP EXAM 2024 WITH 100% CORRECT ANSWERS April 30 1996 - correct answer ICH GCP Development Date Quality - correct answer ICH Q Efficacy - correct answer ICH E Safety - correct answer ICH S Multidisciplinary - correct answer ICH M guidance for industry, consolidated guideance - correct answer ICH E 6 Clinical Safety Data Management Definitions and Standards - correct answer ICH E2A Safety pha

SOCRA CCRP EXAM 2024 WITH 100% CORRECT ANSWERS When was the Nuremberg Code created? - correct answer 1947 What did the Nuremberg Code establish? - correct answer Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? - correct answer 1979 What does the Belmont report do? - correct answer - Establish boundaries between practice and research - created ethical principles: Respect ...

Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSWER-appropriate selection of patients (equality) Language Level ...

Contract Research Organization correct answers 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? correct answers False-they must sign both What is FDA form 3454 correct answers Certification Financial Interests and Arrangements of Clinical Investigators What are the three main ...

SOCRA CCRP EXAM 2024 QUESTIONS WITH COMPLETE SOLUTIONS!!

SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE

SOCRA CCRP EXAM ACTUAL EXAM WITH 200+ QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |A+GRADE

Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A 5 - CORRECT ANSWER-The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT ANSWER-In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled...

SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest Timeline of Historical Events - CORRECT ANSWER-Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - CORRECT ANSWER-respect for persons, beneficence, justice Application of Respect for Persons - CORRECT ANSWER-informed consent (autonomy, choose for themselves) Application of Beneficence - CORRECT ANSWER-risk/benefit analysis Application of Justice - CORRECT ANSW...

Significant risk device is defined as an investigational device that is: a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health...