Socra ccrp study guide - Study guides, Class notes & Summaries

SOCRA CCRP Competency study guide Exam test questions with approved Answers 2024/2025 What determines the causality of an adverse event? - correct answer The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - correct answer Quality improvement Which term best describes an independent assessment of completed work to ensure it will meet applicable quality standards? - correct answer Quality assurance Which term best describe...

CCRP SOCRA FINAL EXAM STUDY GUIDE. 21 CFR Part 11 - correct answer Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - correct answer Electronic Records 21 CFR Part 11 Subpart C - correct answer Electronic Signatures 21 CFR Part 50 - correct answer Protection of Human Subjects 21 CFR Part 50 Subpart B - correct answer Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - correct answer Additional Safeguards for Children in Clinical Investigations 21 CF...

SOCRA CCRP Certification Exam Study Guide 2024 Update

SOCRA CCRP Indispensable Study Assessment Guide Exam Questions with all Questions Accurately Answered Updated 2024/2025 Quality Control (QC) focuses on what? - correct answer identification and correction Quality Assurance (QA) focuses on what? - correct answer prevention Corrective And Preventive Actions (CAPA) process - correct answer to identify root cause of issues or problems and actions to resolve them CAPA plan - correct answer a document that describes the CAPA process A s...

CCRP SOCRA STUDY GUIDE EXPLAINED -4

SOCRA CCRP Practice Study Guide Questions with Distinction level Marking scheme version 2024/2025 What is a CAPA?? - correct answer Corrective and Preventative Action. It is a process to identify root cause of issues or problems and actions to resolve them.. CAPA plan is a document that describes the CAPA process. What is quality assurance? - correct answer Planned and systematic activities necessary to ensure that the trial is performed and the data are generated and in compliance with GC...

5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained 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 The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects...

CCRP SOCRA Objective Assessment Guide Exam Questions and Already graded Solutions and Assured Satisfactions 2024/2025 An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than _ per year. - correct answer once Research may receive approval if there is a minority of the IRB members present at the convened meeting (T/F) - correct answer false Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of on...

SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025 Per ICH E8, methods used to evaluate patient usage of the test drug should be what? - correct answer Specified in the protocol and actual usage documented The study subject asks you why the study is called a double-blind study. You explain double blind as what? - correct answer When the subject and the Investigator and sponsor staff who are involved in the treatment or clinica...