CCRP Guías de estudio, Notas de estudios & Resúmenes

CCRP SOCRA Exam - Practice Exam #1 Questions and Answers 2023 The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator C) Sponsor What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 B) 5 A significant risk device is defined as an investigational device that is: A) Intended as an implant and presents a potential for serious risk to the health, s...

CCRP EXAM PREP 2024/2025 | REAL 300 QUESTIONS WITH 100% CORRECT DETAILED ANSWERS WITH RATIONALES | UPDATED & VERIFIED Who was tried in the Nuremburg Military Tribunals and why? Correct Answer: Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? Correct Answer: After 140 days of proceedings with testimony of 85 witnesses and submissio...

2023 CCRP Exam Prep| 30 PAGES(300 QUESTIONS)| WITH COMPLETE SOLUTIONS

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

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer-PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer-The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct answer-The subject inclusion and exclusion criteria During a multi-site clinical ...

How many days does a sponsor have to report an emergency use of an IP to the FDA? -ANSWER 5 working days How many members must sit on an IRB? -ANSWER 5 How long must an IRB retain records per 21 CFR 56? -ANSWER 3 years after completion of research What are the criteria for IRB approval of research? (7) -ANSWER 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from sub...

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 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subj...

CCRP Exam Questions and Answers (Latest Update 2024)

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: correct answerPI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? correct answerThe subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? correct answerThe subject inclusion and exclusion criteria

Who was tried in the Nuremburg Military Tribunals and why? correct answerDoctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? correct answerAfter 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948