ACRP CCRC Guías de estudio, Notas de estudios & Resúmenes

ACRP CCRC Exam Prep Questions and Answers (All Correct) 299 Questions

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 the investigator allowed to deviate from the protoc...

Adverse Drug Reaction (ADR) - 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) - Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relatio...

ADR - Adverse Drug Reaction Audit - Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Confirmation audit took place Audit Report - Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Documentation of audit events Single Blind Study - Subjects Unaware Double Blind Study - Subjects & Researchers are unaware C...

Protocols - 1) General Information 2) Background info 3) Trial objectives and purpose 4) Trial design 5) Selection and withdrawal of subjects 6) Treatment of Subjects 7) Assessment of Efficacy 8) Assessment of Safety 9) Statistics 10) Source Data/Docs 11) Quality control/assurance 12) ethics 13) data handling and record keeping 14) financing and insurance 15) publication policy 16) supplements Phase 1 - -intro of new drug/investigational product into humans -healthy population...

ACRP CRC Exam Question Bank with 100% Verified and Updated 2024 An adverse event is defined as one which: a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to the drug d) Is life threatening -Answer-C) Is not necessarily causally related to drug An adverse event is one which: a) Is an unfavorable and unintended sign, symptom, or disease b) Is one that is temporally associated with drug regardless of whether it is related or not c) A Only d) A ...

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 Exam Questions and Answers 100% Pass Phase I -Answer-The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? - Answer-Principal investigator Define GCP -Answer-An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 -Answer-Nazi Medical Experime...

ACRP CCRC exam Questions and Answers 100% Correct The _________ has developed the Declaration of Helsinki (DoH): -Answer-World Medical Association; as a statement of ethical principles to provide guidance to physicians and other participats in medical research involving human subjects. (DoH) It is the duty of ________________ in medical research to protect the life, health, privacy and dignity of the human subject. -Answer-the physician (DoH) In medical research, societal/scientific inter...

ACRP CCRC Exam Prep Questions and Answers 100% Pass 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...