hardScenarioDesignMidSeniorStaffLead
You need to change a field on a live trial's data capture system. What evidence does that change have to produce?
7 min readUpdated 2026-08-15
Answer
Short answer
A change to a validated system needs a documented requirement, an assessed risk and impact, approved test evidence that the change does what was specified, an intact audit trail over any affected data, and an approval record showing who authorised release.
Was this answer helpful?
Likely follow-ups
- What would you do differently for a change to a reporting tool that no clinical decision depends on?
- How do you handle data already entered against the old field definition when the new one is not equivalent?
- What does an inspector look for first when they ask to see the audit trail for a single data point?
- Why is validation a lifecycle rather than a one-off event before go-live?
Related questions
- The operations team says there is no rule for this, they just use judgement. How do you model that?hardAlso on audit-trail7 min
- A legal hold lands on Friday afternoon and your nightly deletion jobs run at two. What do you do, and what do you build afterwards?hardAlso on audit-trail6 min
- How do you design a system so an auditor can prove who accessed a record and why?mediumAlso on audit-trail8 min
- A trial site records a visit on a paper worksheet and types it into your system a week later. What has to be true for that data to count?hardAlso on audit-trail6 min