Prepare the trial schematic
This section contains
the following:
Introduction
The trial schematic or flow diagram describes the study design
and
the planned progress of participants through a trial. This is
a
helpful pictorial resource for both funders, review bodies and research
collaborators. It should be included in the
protocol and
trial operations manual.
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Things to
consider
- Describe complex interventions and controls
as accurately and fully as possible.
- The flow diagram should depict information
from
four stages of a trial - enrolment, intervention allocation, follow-up,
and proposed analysis.
Additional
resources
The CONSORT statement website contains a template
flow diagram.
Guidance is also given depending on the complexity of the study design.
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Further Reading
Altman DG et al The revised consort statement for reporting randomised
trials: explanation and elaboration. Annals of Internal Medicine
2001;134:663-694.
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This page was last updated September 2008.