Acrp exam questions and - Study guides, Class notes & Summaries

ACRP CCRC Exam Prep Questions and Verified Answers 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 welfare When is t...

ACRP CCRA Exam Prep Questions and Answers 100% Pass Phase I Trial AKA Human Pharmacology Phase I Trial -Assess tolerance. -Define/describe PK and PD. -Explore drug metabolism and drug interactions, estimate activity. -Done in healthy volunteers.10 -100 people Phase II Trial AKA Therapeutic Exploratory Phase II Trial -Explore use for the targeted indication -estimate dosage for subsequent studies -provide basis for confirmatory study design endpoints, and methodologies. -Trying to find therape...

ACRP CCRC EXAM PREP EXAM QUESTIONS AND ANSWERS Adverse Drug Reaction (ADR) -Answer-In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Adverse Event (AE) -Answer-Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutic...

ACRP CP FINAL EXAM LATEST 2024/2025 REAL EXAM | QUESTIONS AND CORRECT ANSWERS LATEST What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER- Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - ANSWER- Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to ele...

ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS/ ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS

ACRP CCRC EXAM PREP EXAM QUESTIONS AND ANSWERS Adverse Drug Reaction (ADR) -Answer-In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Adverse Event (AE) -Answer-Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutic...

ACRP Exam QUESTIONS AND ANSWERS GRADED A LAEST 2023/2024 What individual serves as the primary liaison between the sponsor and the investigator? - CORRECT ANSWER monitor Who is responsible for verifying that the investigator follows the approved protocol and all approved amendments? - CORRECT ANSWER monitor Who must be notified if a trial is suspended or terminated prematurely? - CORRECT ANSWER the sponsor should promptly inform the investigator/institutions and the regulatory a...

ACRP Exam QUESTIONS AND ANSWERS GRADED A LAEST 2023/2024 What individual serves as the primary liaison between the sponsor and the investigator? - CORRECT ANSWER monitor Who is responsible for verifying that the investigator follows the approved protocol and all approved amendments? - CORRECT ANSWER monitor Who must be notified if a trial is suspended or terminated prematurely? - CORRECT ANSWER the sponsor should promptly inform the investigator/institutions and the regulatory a...