Uade reporting - Study guides, Class notes & Summaries

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

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 ...

Year/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essential. Year and description of the Declaration of Helsinki - 1964- Based on the principles of the Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First significant eff...

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 ANSW...

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 ANSW...

SAE - Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form - 1. A short form consent document 2. And oral presentation of the required elemen...

Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Application of Beneficence - risk/benefit analysis Application of Justice - appropriate selection of patients (equality) Language Level ICF - 6th-8th grade 8 basic elements of ICF - 1...

CCRP Exam Questions answered 100% correct How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days How many members must sit on an IRB? 5 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB approval of research? (7) 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed cons...

CCRP Exam questions well answered latest 2023How many days does a sponsor have to report an emergency use of an IP to the FDA? 5 working days How many members must sit on an IRB? 5 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB approval of research? (7) 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed co...

SOCRA CCRP Exam Flashcards With Complete Solutions Timeline of Historical Events - ANSWER Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ANSWER respect for persons, beneficence, justice Application of Respect for Persons - ANSWER informed consent (autonomy, choose for themselves) Application of Beneficence - ANSWER risk/benefit analysis Application of Justice - ANSWER ...