ACRP CP Exam questions fully solved(verified for accuracy)

1571 IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually 1572 Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP IB 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 - Open Label everyone knows the treatment Study type - Single blind one party knows Tx, usually the patient does not know but the monitoring team does Study type - Double Blind 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 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 Two groups of treatments. One group receives only treatment A and another group receives only treatment B Study Type - Crossover 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 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 Subjects are matched for similar groups; ex: Smokers, sex and age Study Type - Placebo control 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 Done when use of placebo is unethical like antibiotics studies. Means that a known, effective treatment (as opposed to a placebo) is compared to an experimental treatment Define Randomization method used to equify distribution of Tx to subjects; to eliminate bias Define Stratification method used to control assignment based on variables; like disease status; ALLOWS BALANCED COMPARABILITY What are PK studies? Involves taking several blood samples over a period of time to determine how the body handles the substance What is an IDE? 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? 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... - Potential to recruit proper number of patients - enough time to conduct trial - adequate staff - adequate facility. Regulatory Compliance - QA/QC requirements - data collection and reporting requirements - source data access and verification What must you do before approving a Subject Stipend? Must be approved by IRB to make sure the timing and amount is not coercive nor influences the subject phase IV study continual evaluation of a drug after it has been released for marketing phase II study - 100-300 patients - determines efficacy - determines dosing - patients have the disease phase I study a pilot study of a potential drug done with a small number of selected, healthy human volunteers Determines safety Phase III Study - 1,000 to 3,000 patients - determines if treatment is better than current standard - determines therapeutic benefit What is a source document? Any data, document or record created as first point of data entry. This all counts as certified copies What is an Adverse Event? Undesirable medical condition or worsening of pre existing condition. What is an expected AE? Any adverse event that is consistent with applicable product info or that has been reported on previous trials. What does an IRB evaluate? - The rights, safety and well being of subjects - subject selection procedures - scientific tenability of a study Describe IRB members - 5 members - 1 cannot be affiliated with institution - 1 must be concerned with non scientific - cannot all be MDs Define a SUA Any SAE that is unexpected and cannot be found in the IB or drug label. Also referred to as the SUSAR What is an AESI - An adverse event of special interest - cannot be serious or non serious - has a concern specific to sponsors product - requires ongoing monitoring & further investigation Which 4 documents must be reviewed by IRB - protocol - investigational brochure - sample consent form - all advertising What is the timeframe for sponsor to report FATAL SAE? 7 days. 15 days if written. Must be reported to FDA (regulatory authority) Define contemperaneous - Existing or occurring in the same period of time - data is only credible if recorded and documented at the time of action True or False: If you suspend or terminate your own study, you must notify the IRB True What is the timeframe for sponsor to report non fatal SAE? 15 days (must be reported to regulatory authority) What is an SAE? - An adverse event that is serious - results in death or is life threatening - requires hospitalization - disability occurs What is the timeline to report an SAE? - Site has 24 hours to report and enter SAE - if non-drug related, you have 2 business days - safety team has 5 business days to forward to medical monitoring What is the responsibility of a regulatory authority? - involved before conducting research - monitors ADR for investigational & marketed drugs - controls drug promotion and advertising What does ALCOA stand for? Attributable Legibility Contemporaneous Original Accurate