Socra study guide - Study guides, Class notes & Summaries

SOCRA CCRP STUDY GUIDE EXPOUNDED -10

SOCRA CCRP Certification Exam Study Guide 2024 Update.SOCRA CCRP Certification Exam Study Guide 2024 Update.

SOCRA CCRP STUDY GUIDE -17

SOCRA CCRP Certification Exam Study Guide 2024 Update..SOCRA CCRP Certification Exam Study Guide 2024 Update..

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...

IRB approval - ANSWER-the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and other institutional and federal requirements. Contract Research Organization (CRO) - ANSWER-a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - ANSWER-an investigational new drug application, aka a notice of claimed inv...

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 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...