SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest

SOCRA CCRP Prep Exam Study Questions and Answers 2024 latest 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 Justice - CORRECT ANSWER-appropriate selection of patients (equality) Language Level ICF - CORRECT ANSWER-6th-8th grade 8 basic elements of ICF - CORRECT ANSWER-1. purpose, duration, and procedures 2. risks/discomforts 3. benefits 4. alternatives 5. confidentiality 6. compensation/medical treatments injury 7. contact information 8. voluntary participation and discontinuation at any time Long ICF - CORRECT ANSWER-standard consent form Short ICF - CORRECT ANSWER-a document that elements of ICF, orally stated, understood by participant 4 components of consent process for short form - CORRECT ANSWER-1. short form document 2. oral presentation of ICF elements 3. IRB approved summary 4. a witness When can you use short form? - CORRECT ANSWER-language, short window ICF monitoring - CORRECT ANSWER-1. most recent IRB approved version 2. signature present 3. subject dated/correct date 4. errors corrected by a single line 5. all pages present SAE Reporting Requirement - CORRECT ANSWER-immediately investigator, 15 days for sponsor UADE Reporting Requirement - CORRECT ANSWER-10 days investigator, 10 days for sponsor Consent and Assent for children - CORRECT ANSWER-Parental consent from 1 or both parents or LAR required, and child assent may be required as determined by IRB Time period where financial disclosure is needed - CORRECT ANSWER-during the study and one year after completion