Socra study guide - Study guides, Class notes & Summaries

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 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 Certification Exam Study Guide 2024 Update

SOCRA CCRP Study Guide with complete solutions | Latest 2023/2024 Biometrics ️ 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 ️ An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec...

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...

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 cover sheet -Table of contents -Investigative Plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/Toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential) ...

SOCRA CCRPSEA Report Requirements Exam Study Guide Questions and Answers 2023/2024 Timeline of Historical Events - correct answer Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - correct answer respect for persons, beneficence, justice Application of Respect for Persons - correct answer informed consent (autonomy, choose for themselves) Application of Beneficence - correct answer risk/benefit analysis Application of ...