Ccrp exam stuvia - Study guides, Class notes & Summaries

When a short form is used for informed consent the witness must sign the short form or the summary? - ANSWER- False-they must sign both What is FDA form 3454 - ANSWER- Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the Belmont Report? - ANSWER- Respect for persons. Beneficence. Justice. Phase III - ANSWER- Study Participants: 300 to 3,000 volunteers who have the disease or condition Length of Study: 1...

CCRP Exam Questions and Answers Rated A+ 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 equita...

Contract Research Organization - ANSWER-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 informed consent the witness must sign the short form or the summary? - ANSWER-False-they must sign both What is FDA form 3454 - ANSWER-Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical princip...

CCRP Exam Prep Questions and Answers, Rated A+ Who was tried in the Nuremburg Military Tribunals and why? - 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? - ANSWER After 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 sen...

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER-5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER-3 Al IRB records need to be kept for ____ years follow completion of research - ANSWER-3 FDA will provide written determinati...

The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANSWER-Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. Which of the follow...

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER-Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - ANSWER-Respect for Persons, Beneficence, Justice The principle of justice in the Belmont report relates to - ANSWER-Distributions of burdens and benefits Respects for person in the Belmon...

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER -Determining that the study has a maximization of benefits and a minimization of risks. Which of the following are the three principles discussed in the Belmont Report? - ANSWER -Respect for Persons, Beneficence, Justice The principle of justice in the Belmont report relates to - ANSWER -Distributions of burdens and benefits Respects for person in the Bel...

Certified Clinical Research Professional (CCRP) Exam Questions and Answers When isn't an IND application needed? - ANSWER 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) - ANSWER 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...

CCRP: Exam Complete Questions and Answers Sensory-level TENS uses frequencies b/w: - ANSWER 50-150 Hz Iliopsoas attaches to which bone: - ANSWER Femur Deep heating agents: - ANSWER -Ultrasound -Diathermy Tarsal joint ROM angles: - ANSWER -Flexion: 30-40 degrees -Extension: 155-165 degrees