- To accept the questionnaire as is.
- To urgently advise that an unvalidated instrument can lead to unreliable and invalid data, compromising the study's conclusions, and to recommend using a validated tool.
- To only focus on the sample size.
- To assume the questionnaire is good.
169. A critical situational clinical trial protocol describes using an unvalidated questionnaire to measure a key patient outcome. What is the urgency for a biostatistician’s intervention?
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