Socra ccrp exam 2023 2024 - Study guides, Class notes & Summaries

Socra CCRP Exam Questions & Answers 2023/2024 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 Investigato...

SOCRA CCRP Exam Questions & Answers 2023/2024 ADME - ANSWER-absorption, distribution, metabolism, excretion BA - ANSWER-bioavailability BE - ANSWER-bioequivalence CTA - ANSWER-clinical trial authority CTI - ANSWER-clinical trial investigator DMC - ANSWER-Data Monitoring Committee GLP - ANSWER-Good Laboratory Practices GMP - ANSWER-Good Manufacturing Practices PSUR - ANSWER-Periodic Safety Update Report IEC - ANSWER-Independent Ethics Committee RA - ANSWER-regul...

SOCRA CCRP Nuremburg Code Certification Exam study guide Question with correct answers 2023/2024 Nuremburg Code - correct answer The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - correct answer 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified ...

SOCRA CCRP Exam Questions and Answers 2023/2024

SOCRA CCRP Exam Questions and Answers 2023/2024

CCRP SoCRA 21 CFR PARTS Exam Questions and certified Answers 2023/2024 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...

CCRP SOCRA CFR, ICH FDA Practice Exam Questions with Guaranteed Answers 2023/2024 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator - correct answer C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 - correct answer B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a p...

SoCRA Common Terms and Key phrases in CCRP Certification Exam Study Guide Questions and Approved Answers 2023/2024 Biometrics - correct answer A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - correct answer an environment in which system access is controlled by persons who are responsible fo...

Socra CCRP Belmont Report and 21 CFR Exam Review Questions and Answers 2023/2024 Contract Research Organization - correct 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? - correct answer False-they must sign both What is FDA form 3454 - correct answer Certification Finan...

Socra CCRP EXAM-with 100% verified solutions -2023-2024