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A writer who sees only result tables may struggle to distinguish planned methods from analyses actually performed. Access means providing controlled, relevant context rather than simply sending a large collection of study documents with unclear status.
The publication decision
Identify the protocol, amendments, statistical analysis plan and report versions needed to describe methods within publication scope. Explain each document’s applicability and role. Prevent gaps from being filled by the writer’s unsupported assumptions. Access should be proportionate to the task, avoiding unnecessary sharing of directly identifiable participant-level information alongside the documents.
Worked example
For example, a manuscript uses visit timings from an earlier protocol while result tables reflect an amendment. Instead of merely sending another file, the team explains the version change and methodological effect. It checks that methods and tables share the appropriate basis. Open questions go to the statistician or relevant scientific owner for clarification.
Coordination checks
- List method-source documents with their versions and dates.
- Compare table scope with the applicable analysis plan.
- Escalate uncertain method descriptions without inventing assumptions.
Acceptance and boundaries
Acceptance means the writer can trace a methods statement to an authoritative document. Providing access does not approve every interpretation; scientific review still matters. Manage the sharing environment and access duration according to the publication arrangements. When a source changes, explicitly review the manuscript sections affected rather than assuming the new file automatically updates the text.
Frequently asked questions
- Should every study document be shared?
- Define the necessary scope. Unnecessary file volume can make the correct version harder to identify.
- Can a writer complete a missing method description?
- They should not present an unsupported assumption as fact; manage it as an open question requiring authorised clarification.