Socra study guide - Study guides, Class notes & Summaries

IRB approval - 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) - a person that assumes, as an independent contractor with the sponsor, one or more obligations of a sponsor. Investigation New Drug (IND) - an investigational new drug application, aka a notice of claimed investigational exemptio...

CITI - SoCRA - GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Exam Guide. Which of the following lists the three principles included in the Belmont Report? - CORRECT ANSWER Respect for Persons, Beneficence, Justice Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? - CORRECT ANSWER Determining that the study has maximized benefits and minimized risks. Which of the following best des...

21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subpart C IRB Functions and Operati...

SoCRA Certification Exam Study Guide with Complete Solutions 100% Verified 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 for the content of electronic records that...

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 Certification Exam Study Guide 2024 UpdateSOCRA CCRP Certification Exam Study Guide 2024 Update

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 2023 EXAM WITH OVER 230 ACTUAL QUESTIONS AND VERIFIED ANSWERS GRADED A+ (2024 UPDATE)

CCRP SOCRA EXAM 2023 QUESTIONS AND ANSWERS