ACRP Practice Exam-Questions and Answers all
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How to determine if ADE is unexpected - ✔✔Refer to the IB, if the occurrence adds
new information, new reaction or different severity, it is considered unexpected
What type of adverse event or drug reaction requires expedited reporting? -
✔✔When it is both serious and unexpected
Other than ADE, what should be reported in a safety report? - ✔✔Significant safety
findings in animal models, lack of efficacy, increased frequency of expected ADEs
Who determines the causality of an ADE? - ✔✔Investigator
Who determines if ADE is unexpected? - ✔✔Investigator
Reporting timeframe of life threatening unexpected ADE - ✔✔Must be reported by
sponsor to regulatory authority within 7 days of awareness, and provide a full report
within the following 8 days
Reporting timeframe of non-life threatening but serious and unexpected ADE -
✔✔Sponsor must report to regulatory authority within 15 days of awareness
Minimum criteria for reporting expedited ADE - ✔✔Identifiable patient, suspect
medical product, identifiable reporting source, and an identifiable outcome that can be
considered serious and unexpected which was likely caused by the drug. Submit
additional information as it comes available
, Managing blinding when reporting serious and unexpected ADE - ✔✔Break blind only
for that patient, sponsor and investigator. Do not break blind if death is an efficacy
endpoint. Blinding plan and breaking agreement should be established before the trial
begins
Managing ADR when there is more than one use for IP - ✔✔ADR should be reported
across all forms, dosage, route etc. May cause redundancy but will avoid under-
reporting
Reporting placebo/comparator reactions - ✔✔Sponsor is responsible for deciding if
placebo/comparator reaction should be reported to manufacturer or regulatory
authority (but they must report to one or the other). Placebo events do not qualify for
expedited reporting
What is the PRBER? What is it reporting? What periods? Why is it useful? -
✔✔Periodic Risk Benefit Evaluation Report. Common report for all marketed
products (all routes and dosages unless a separate report is needed). Essentially the end
product of PSURS, includes safety, efficacy, important findings etc. Periods vary (6
months for first 2 years, then extended). Includes serious AEs, compares old and new
information, concise unless a risk-benefit evaluation is needed. Useful because it reports
safety for real world population, not just patients on a trial
MAH - ✔✔Marketing Authorization Holder, usually the manufacturer of the drug
What is the common reporting period for PBRER? - ✔✔every 6 months for first 2
years then can be extended depending upon how much we know about the drug and
how long it has been on the market. Can also call for ad hoc reports
Who is responsible for making PRBER and submitting? - ✔✔MAH
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