Research, Development & Innovation Flashcards

Which element of a protocol is specifically designed to describe how missing data will be handled in the statistical analysis?

Answer: Statistical analysis plan (SAP)

The Statistical Analysis Plan pre-specifies analytical methods including imputation strategies for missing data before unblinding.

A healthcare scientist identifies a potential improvement to an existing NHS diagnostic pathway. Under the NHS NICE Evidence Standards Framework, what category would this innovation most likely fall into?

Answer: Diagnostics guidance

NICE Diagnostics Guidance evaluates new or existing diagnostic technologies, including tests and decision-support tools used in NHS practice.

What is the key distinction between a systematic review and a narrative review?

Answer: Systematic reviews use a pre-registered, reproducible search and selection strategy; narrative reviews do not

Systematic reviews follow a rigorous, pre-specified, and reproducible methodology to minimise bias in identifying and synthesising evidence.

In the innovation adoption lifecycle, which group is characterised by adopting new technologies only after the majority of the market has done so?

Answer: Laggards

Late majority adopters are sceptical and adopt innovations only after most others have, often driven by economic necessity or peer pressure.

Which document outlines the conditions under which a sponsor delegates specific trial responsibilities to the investigator site?

Answer: Clinical Trial Agreement (CTA) / delegation log

A delegation log (often part of the Clinical Trial Agreement) formally records which responsibilities the sponsor has delegated to site personnel.

A scientist conducts a method comparison study between a new point-of-care device and the reference laboratory method. Which statistical approach is most appropriate to assess agreement?

Answer: Bland-Altman analysis

Bland-Altman analysis plots the difference between two methods against their mean, revealing bias and limits of agreement rather than just correlation.

Under the UK Policy Framework for Health and Social Care Research, who holds ultimate accountability for ensuring a research project is conducted according to the approved protocol?

Answer: The Chief Investigator (CI)

The Chief Investigator is accountable for the overall conduct of a multi-site study and ensuring protocol compliance across all sites.