Research, Development & Innovation Flashcards
7 cards from real STP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Research, Development & Innovation flashcards as text
Which statistical concept describes the probability of detecting a true effect in a study, given that the effect actually exists?
Answer: Statistical power
Statistical power (1 − β) is the probability that a study will correctly reject the null hypothesis when a true effect exists.
In clinical research, what is the primary purpose of a Data Safety Monitoring Board (DSMB)?
Answer: To independently review accumulating data and recommend stopping the trial if necessary
A DSMB independently monitors participant safety and trial data, recommending early termination if harm or clear benefit is detected.
Which type of validity refers to how well study findings can be applied to populations or settings beyond the original study?
Answer: External validity
External validity (generalisability) concerns whether results can be applied to other populations, settings, and time points.
A researcher wishes to reduce the risk of allocation bias in a randomised controlled trial. Which technique is most effective?
Answer: Concealed allocation with a centralised randomisation service
Concealed allocation prevents recruiters from predicting the next assignment, eliminating selection bias at enrolment.
Which Good Clinical Practice (GCP) principle states that the rights, safety, and wellbeing of trial subjects must prevail over the interests of science and society?
Answer: The overriding primacy of participant welfare
ICH GCP Principle 2.3 explicitly states that the rights, safety, and wellbeing of trial subjects are the most important considerations and should prevail over the interests of science and society.
In qualitative research, what does 'transferability' most closely correspond to in quantitative terms?
Answer: External validity / generalisability
Transferability in qualitative research parallels external validity in quantitative research, asking whether findings apply in other contexts.
When a laboratory introduces a novel diagnostic assay, which regulatory framework in the UK governs its validation before clinical use?
Answer: UKCA/CE marking and UKAS accreditation under ISO 15189
In the UK, in-vitro diagnostic devices require UKCA/CE marking, and clinical laboratories must meet ISO 15189 standards audited by UKAS.