Justification On The Collection Of Individual Data Items

Dear all,

I was just wondering whether in your CTUs your study teams list all data collection items and whether your CI/Stats team systematically go through each of these and provide justification for their collection and how they will contribute to the endpoints of the intended studies? If so, how is this documented, please?

I am currently involved in a working group looking at data lifecycle and trying to determine the most effective way of collecting the dataset which adequately allows us to answer the research question without being to onerous for sites and allows us to streamline downstream activities.

Thanks in advance for your comments,

Liz Merrifield

QA Manager, Centre for Trials Research, Cardiff University

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