ACRP CP EXAM WITH LATEST QUESTIONS AND 100% CORRECT ANSWERS ALREADY GRADED A+

ACRP CP EXAM WITH LATEST QUESTIONS AND 100% CORRECT ANSWERS ALREADY GRADED A+ 1571 - ANS-IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 - ANS-Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB - ANS-Clinical and non-clinical data on the investigational product that is relevant to the study in human subjects; supplied prior to regulatory approval Study Type - Placebo control - ANS-in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo Study Type - Active control - ANS-Done when use of placebo is unethical like antibiotics studies. Study type - Open Label - ANS-everyone knows the treatment Study type - Single blind - ANS-one party knows Tx, usually the patient does not know but the monitoring team does Study type - Double Blind - ANS-2 or more people are blinded, usually the patient and monitoring tram do not know which drug is given. A 3rd party unblinded pharmacist is used and an unblinded CRA is needed Study Type - Double dummy - ANS-Use to blind similar Tx's; one is active and one is placebo. This occurs when the drug and placebo cannot be made identical (pill vs liquid) Study Type - Parallel - ANS-Two groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover - ANS-Usually Chronic disease; receives more than one Tx with a washout in between. A then B; could be randomized so the sequence changes Define Overall Survival - ANS-the length of time from treatment until time of death. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Define Cohort - ANS-Subjects are matched for similar groups; ex: Smokers, sex and age Means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment Define Randomization - ANS-method used to equify distribution of Tx to subjects; to eliminate bias Define Stratification - ANS-method used to control assignment based on variables; like disease status; ALLOWS BALANCED COMPARABILITY What are PK studies? - ANS-Involves taking several blood samples over a period of time to determine how the body handles the substance What is an IDE? - ANS-Investigational device exemption Allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data What is GCP? - ANS-Standard for designing, conducting, and reporting clinical trials; to make sure data is acurate, and to make sure the rights, integrity and confidentiality of patient is protected. ICH GCP Requirements before accepting a protocol... - ANS-- Potential to recruit proper number of patients - enough time to conduct trial - adequate staff - adequate facility. Who does the investigator need to inform if he/she deviates from the protocol? - ANS-Regulatory authorities The IRB The sponsor When does unblinding occur in a study? - ANS-When an investigator wants to make sure a particular subject is not enrolled into placebo arm in case of SAE. Which groups of potential subjects are mentioned as vulnerable subjects? - ANS-- children - pregnant women - cognitively impaired persons Regulatory Compliance - ANS-- QA/QC requirements - data collection and reporting requirements - source data access and verification What must you do before approving a Subject Stipend? - ANS-Must be approved by IRB to make sure the timing and amount is not coercive nor influences the subject phase IV study - ANS-continual evaluation of a drug after it has been released for marketing phase II study - ANS-- 100-300 patients - determines efficacy - determines dosing - patients have the disease phase I study - ANS-a pilot study of a potential drug done with a small number of selected, healthy human volunteers Determines safety Phase III Study - ANS-- 1,000 to 3,000 patients - determines if treatment is better than current standard - determines therapeutic benefit What is a source document? - ANS-Any data, document or record created as first point of data entry. This all counts as certified copies What is an Adverse Event? - ANS-Undesirable medical condition or worsening of pre existing condition. What is an expected AE? - ANS-Any adverse event that is consistent with applicable product info or that has been reported on previous trials. What does an IRB evaluate? - ANS-- The rights, safety and well being of subjects - subject selection procedures - scientific tenability of a study