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SOCRA Practice Test 1 Revision Questions with Answers 2023. Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest form? FDA Form 3454 If the investigator did have financial arrangement with t...

SOCRA Comprehensive Exam Questions with Updated Answers 2023 lectronic signature are currently accepted for any and all records, paper or electronic form. True or False? False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, a...

Socra Assessment Test 3 with Revised Questions and Answers of 2023 Contract Research Organization 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 ...

SOCRA Study Practice Exam Questions with Detailed Answers 2023 When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cove...

SOCRA - CCRP (high level)Study Guide Test Reviewed Questions and Answers 2023. Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points ...

SOCRA CCRP Abbreviations Exam Questions with Updated Answers 2023 ADME absorption, distribution, metabolism, excretion BA bioavailability BE bioequivalence CTA clinical trial authority CTI clinical trial investigator DMC Data Monitoring Committee GLP ...

SOCRA CCRP Certification Exam with Revised Questions And Detailed Answers 2023 Nuremburg Code The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements 1. Voluntary informed consent 2. research benefits society 3. should be based on prior an...

SOCRA CCRP Certification Test 6 Updated Questions and Answers 2023 CFR Title 21: Part 11 Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created...

SOCRA-Revision Questions with Detailed Answers 2023 Belmont Report was created as part of? The national Research Act of 1974. Who was the Belmont Report formulated by? The National Commission for the protection of human subjects in biomedical and behavioral research. What year was t...