Ccrp Study guides, Class notes & Summaries

SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADESOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE

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CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS

MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) | Latest 2023/2024 5 ️ The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained ️ In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor ️ The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a s...

ACRP CCRC Exam Prep Questions and answers 100% correctWhat are expected or possible consequences of over-estimation of recruitment potential? - 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? Subject welfare When is the i...

Adverse Event (AE)/Adverse Experience - Answer- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) - Answer- All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction - Answer- An adverse reaction, the nature or severity of which is not consistent with the 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 will be sought from subjects or LARs 5. Informed ...

Clinical Trial - Answer- process of studying human subjects to assess the effect of a particular intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable events. Endpoint or Outcome - Answer- Clinical event, measurable indicator, subject reported response Feasibility of a Study - Answer- Assessment of resource needs, regulator requirements, and potential level of risk of harm for human subjects participating in study Necessary controls in ...