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...

A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as a) An adverse event b) An adverse drug reaction c) An unexpected adverse drug reaction d) A serious adverse event b) A causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out A response to a medical product means (check all options that apply) a) A causal relationship bet...

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 Practice Test Exam Questions And Answers (Updated And Verified) What are the liver function tests? (LFT) - answerLiver function tests (also known as a liver panel) are blood tests that measure different enzymes, proteins, and other substances made by the liver. * Albumin, a protein made in the liver * Total protein, This test measures the total amount of protein in the blood. * ALP (alkaline phosphatase), ALT (alanine transaminase), AST (aspartate aminotransferase), and gamma-glutam...

ACRP-CP Exam Review Questions And Answers (Updated And Verified) Adverse Drug Reaction (ADR) - answerAll noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (A...

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 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...

ACRP CCRC Exam Practice Questions and Verified Solutions What is the goal of a Confirmatory trial? ANSWER to provide firm evidence of efficacy or safety What is the goal of an Exploratory trial? ANSWER to help provide a basis for confirmatory trials When is a composite variable useful? ANSWER when a single variable cannot be selected from multiple measurements What does a global assessment variable measure? ANSWER the overall safety, overall efficacy, and/or overall usefulness of a t...

ACRP-CP Exam (Graded A Plus) with Questions and Answers Crossover ANSWER when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel ANSWER when subjects are randomized to 1 of 2 or more arms, each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses, and one or more control treatments, such as placebo and/or an active comparator A spons...