STP Research, Development & Innovation 3 — Questions and Answers
Question 1: Which element of a protocol is specifically designed to describe how missing data will be handled in the statistical analysis?
- Eligibility criteria section
- Statistical analysis plan (SAP) (Correct answer)
- Consent form appendix
- CONSORT flow diagram
Correct answer: Statistical analysis plan (SAP)
The Statistical Analysis Plan pre-specifies analytical methods including imputation strategies for missing data before unblinding.
Question 2: 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?
- Highly Specialised Technologies guidance
- Medical technologies (MedTech) evaluation programme
- Technology Appraisal guidance
- Diagnostics guidance (Correct answer)
Correct answer: Diagnostics guidance
NICE Diagnostics Guidance evaluates new or existing diagnostic technologies, including tests and decision-support tools used in NHS practice.
Question 3: What is the key distinction between a systematic review and a narrative review?
- Systematic reviews only include RCTs; narrative reviews include all study types
- Systematic reviews use a pre-registered, reproducible search and selection strategy; narrative reviews do not (Correct answer)
- Narrative reviews always include a meta-analysis
- Systematic reviews are shorter and quicker to conduct
Correct 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.
Question 4: In the innovation adoption lifecycle, which group is characterised by adopting new technologies only after the majority of the market has done so?
- Early adopters
- Early majority
- Late majority
- Laggards (Correct answer)
Correct answer: Laggards
Late majority adopters are sceptical and adopt innovations only after most others have, often driven by economic necessity or peer pressure.
Question 5: Which document outlines the conditions under which a sponsor delegates specific trial responsibilities to the investigator site?
- Patient information sheet
- Clinical Study Report (CSR)
- Clinical Trial Agreement (CTA) / delegation log (Correct answer)
- Investigational Medicinal Product Dossier (IMPD)
Correct 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.
Question 6: 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?
- Pearson correlation coefficient
- Bland-Altman analysis (Correct answer)
- Chi-squared test
- Kaplan-Meier survival analysis
Correct 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.
Question 7: 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?
- The Chief Investigator (CI) (Correct answer)
- The Research Ethics Committee (REC) chair
- The funder of the study
- The local R&D office
Correct 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.
STP Research, Development & Innovation 3
Which element of a protocol is specifically designed to describe how missing data will be handled in the statistical analysis?