ACRP Study guides, Class notes & Summaries

ACRP Certification Exam Abbreviation List ADR - answerAdverse Drug Reaction AE - answerAdverse Event ALT - answerAlanine transaminase AST - answerAspartate transaminase b.i.d. - answertwice a day BP - answerBlood pressure BUN - answerBlood Urea Nitrogen C - answerCelsius CIOMS - answerCouncil for International Organizations of Medical Sciences CK - answerCreatine Kinase CRA - answerClinical Research Associate CRC - answerClinical Research Coordinator CRF - answerCase Report Form CR...

ACRP CCRC EXAM PREP Questions With 100% Verified Answers Adverse Drug Reaction (ADR) - answerIn 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) - answerAny untoward medical occurrence in a patient or clinical investigation subject administered a ph...

ICH ACRP Exam Questions With Verified Solutions LAR - answerLegally Authorized Representative Essential documents - answerdocuments which individually and collectively permit evaluation of the conduct of a study and quality of the data produced Who developed the Declaration of Helsinky? - answerthe World Medical Association Phase 1 study - answerdesigned to determine the metabolic and pharmacologic action of the drug in humans monitor - answerultimately responsible for source data verifi...

ACRP Exam Questions With 100% Verified Answers What individual serves as the primary liaison between the sponsor and the investigator? - answermonitor Who is responsible for verifying that the investigator follows the approved protocol and all approved amendments? - answermonitor Who must be notified if a trial is suspended or terminated prematurely? - answerthe sponsor should promptly inform the investigator/institutions and the regulatory authorities of the termination or suspension an...

ACRP CP Exam Questions And Answers (Updated And Verified) 1571 ` - answerIND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - answerInvestigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - answerClinical and non-clinical data on the investigational product that is relevant to the study in human subjects; supplied prior to regulatory approva...

ACRP EXAM 2019 WITH UPDATED ANSWERS 2024

ACRP PRACTICE TEST 2023 WITH UPDATED CORRECT ANSWERS 2024

True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. - False As part of their risk assessment process the sponsor determines that there is a high likelihood that enrollment in the trial will be challenging and slow. Which of the following is the best choice in this situation: a. The sponsor should develop a risk management plan to handle this operational risk b. The sponsor should develop a proactive recruitment strategy to mitigate the risk of ...

ACRP Bootcamp Exam