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An adaptation can be statistically correct yet implemented late at sites. Time between review, authorisation, system modification and site communication can change expected design behaviour; operational planning should not assume that every decision takes effect instantaneously.
Define the question and assumptions
Map recruitment, assignment and follow-up steps affected by the decision. Prespecify which rules govern people enrolled during transition. Account for realistic implementation delays in simulations or operational assessment. A planned adaptation does not itself establish that every applicable review, authorisation and site preparation step has already been completed.
Hypothetical study example
In a hypothetical study, one arm closes to recruitment while some sites still use the earlier allocation version. The team tracks the transition and participants enrolled during it. It records actual implementation evidence instead of treating the committee decision time as the simultaneous activation time at all sites.
Design review checks
- Track decision, authorisation and actual implementation times as separate milestones.
- Test prespecified assignment rules for participants entering during the transition period.
- Verify completion of system and site updates using specific operational records.
Record the decision and its limits
An accepted workflow makes the effective version and timing understandable to everyone involved. Assess delays affecting sample size, supply and interpretation. Do not backdate implementation for convenience. Report delayed or unrealised adaptations with reasons and consequences, allowing readers to distinguish the planned design from the trial that actually occurred.
Frequently asked questions
- Does a committee decision mean immediate implementation?
- No. Authorisation, systems and site transition steps must also be completed.
- Are participants enrolled during transition removed?
- No. Retain records and apply the prospectively defined transition rules.