Study guides, Class notes & Summaries

A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2...

ACRP PRACTICE EXAM-with 100% verified solutions2023-2024

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

ACRP CCRA Exam Prep

ACRP CCRA Flashcards