Target protocol-to-data mapping

Map trial requirements onto sources

Show the target requirement and recorded implementation side by side. Document unavailable variables and deviations, including their likely effects on identification or interpretation. Availability is not validation.

Flow diagram

Target protocol-to-data mappingF1.S1Inventory available sourcesF1.S2Map each target elementF1.S3Identify unavailable requirementsF1.S4Evaluate feasibility and deviationsF1.S5Freeze emulation specificationsF1.N1Protocol-to-data registerTarget elementObserveddefinitionSourceDeviationLikely impactEligibilityAssignmentTime zeroOutcomeConfoundersFollow-upF1.N2Assumptions and rationaleF1.N3Method and protocol evidenceF1.S0 Start flowTarget protocol-to-data mappingF1.S999 End flowEnd flow

Steps

Inventory available sources

Assess access, provenance, capture windows and linkage quality.

Map each target element

Translate eligibility, strategies, outcomes and follow-up into observable definitions.

Identify unavailable requirements

Record proxies, delays, unmeasured confounders and unsupported contrasts.

Evaluate feasibility and deviations

Document how each deviation could affect interpretation or bias.

Freeze emulation specifications

Version code lists, algorithms and protocol-to-data decisions.

Target protocol-to-data mapping

End flow

Tables and supporting information

Protocol-to-data register

Protocol-to-data registerTarget elementObserveddefinitionSourceDeviationLikely impactEligibilityAssignmentTime zeroOutcomeConfoundersFollow-up

Do not silently replace target requirements with available proxies.

Assumptions and rationale

Availability does not establish validity. Evaluate measurement error and missing confounders before claiming identification.

Method and protocol evidence

Attach the protocol, methodological sources and versioned software specification supporting these decisions. Record citations and provenance; do not enter participant identifiers.

Sources