Guías de estudio, Notas de estudios & Resúmenes

Who was tried in the Nuremburg Military Tribunals and why? - 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? - 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 sentenced to death and executed 6/2/1948. What historical docume...

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 consent will be sought from subjects or LARs 5. Informed co...

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? - -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 consent wi...

CCRP Exam Questions and answers, VERIFIED/ Code of Federal Regulations that applies to Investigational New Drug Applications - -21 CFR 312 Who monitors the progress of all clinical trial investigations being conducted under an IND? - - Sponsor A request to export an investigational drug from the U.S. must include - -quantity of drug per shipment, frequency of shipment, and a statement that the drug will be used for research purposes only and that the drug may legally be used by that co...

ACRP CCRC Exam Prep QUESTIONS AND ANSWERS ALREADY PASSED What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - ANSWER Subject welfar...

CCRC Exam Actual QUESTIONS AND ANSWERS ALREADY PASSED What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - ANSWER To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participa...

CCRC Exam Actual QUESTIONS AND ANSWERS ALREADY PASSED What is the purpose of the ICH's Good Clinical Practice: consolidated Guideline? - ANSWER To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects. What guideline's purpose is to define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participa...

ACRP CCRC Exam Prep QUESTIONS AND ANSWERS ALREADY PASSED What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - ANSWER Subject welfar...

CCRP SOCRA Exam Graded A+ When was the Nuremberg Code created? - ANS1947 What did the Nuremberg Code establish? - ANSWorldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. When was Belmont report established? - ANS1979 What does the Belmont report do? - ANS- Establish boundaries between practice and research - created ethical principles: Respect for persons, Beneficence, and Justice - ensure applications of informed con...

CCRP SOCRA Exam Graded A+ April 30 1996 - ANSICH GCP Development Date Quality - ANSICH Q Efficacy - ANSICH E Safety - ANSICH S Multidisciplinary - ANSICH M guidance for industry, consolidated guideance - ANSICH E 6 Clinical Safety Data Management Definitions and Standards - ANSICH E2A Safety pharmacology studies for human pharmaceuticals - ANSICH S7A Electronic records, electronic signatures - ANS21 CFR Part 11 Informed Consent - ANS21 CFR Part 50 Financial Disclosures - ANS21 CFR Par...