Risk Management & Quality Assurance Flashcards
7 cards from real CRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Management & Quality Assurance flashcards as text
Which regulatory term describes the principle that a sponsor must maintain oversight of all research activities, even those delegated to a CRO?
Answer: Non-delegable sponsor oversight
Under FDA regulations and ICH GCP, sponsors retain ultimate responsibility for trial conduct and must maintain oversight of all delegated functions regardless of CRO involvement.
What is the primary risk associated with 'data dredging' or post-hoc subgroup analyses in research?
Answer: Inflated Type I error rate and false-positive findings
Unplanned multiple comparisons dramatically increase the chance of finding statistically significant results by chance alone, inflating the Type I error rate.
In the context of quality control, what is 'double data entry' designed to detect?
Answer: Data transcription errors
Double data entry requires two operators to independently enter the same data, and discrepancies between entries flag potential transcription errors for correction.
A 'sentinel event' in research quality management is best defined as:
Answer: An unexpected serious adverse event signaling a potential systemic safety failure
A sentinel event is an unexpected serious occurrence that signals underlying systemic problems requiring immediate investigation to prevent future similar events.
Which risk assessment matrix component represents the product of probability and impact?
Answer: Risk score or risk level
The risk score (or risk level) is calculated by multiplying the probability of a risk occurring by its potential impact, allowing risks to be prioritized.
A clinical site fails to obtain re-consent from participants after a significant protocol amendment. This represents:
Answer: A serious non-compliance that must be reported to the IRB and sponsor
Failure to re-consent after a significant amendment violates GCP and participant rights, constituting serious non-compliance requiring immediate reporting to the IRB and sponsor.
What distinguishes a 'quality indicator' from a 'quality standard' in research quality management?
Answer: Quality indicators measure performance against a standard, while quality standards define the required level
Quality standards define the required performance level (e.g., 100% consent documentation), while quality indicators are measurable metrics used to assess how well those standards are being met.