Study Setup & Planning

DMP, timelines, specifications, UAT, change control, and study start-up essentials.

12 terms

Independent review process to confirm endpoint events using predefined criteria.

Governance for controlled changes to systems/specs, including impact assessment and approvals.

Data elements that directly affect subject safety, primary endpoints, or key regulatory decisions and therefore receive higher scrutiny.

A study-specific document describing how data will be collected, validated, cleaned, coded, and delivered, including roles and timelines.

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DMP, timelines, specifications, UAT, change control, and study start-up essentials.

12 terms

Independent review process to confirm endpoint events using predefined criteria.

Governance for controlled changes to systems/specs, including impact assessment and approvals.

Data elements that directly affect subject safety, primary endpoints, or key regulatory decisions and therefore receive higher scrutiny.

A study-specific document describing how data will be collected, validated, cleaned, coded, and delivered, including roles and timelines.

Data Review Plan

Plan defining review activities, listings, frequency, roles, and escalation rules.

Controlled updates to eCRFs with traceability across amendments and change control.

Formal confirmation that EDC build, training, and support processes are ready for sites.

Assess how protocol changes affect CRF, checks, reports, and timelines.

Retesting key functionality after changes to ensure no unintended breakage.

Summary of changes made in a build/version so teams understand what changed.

Linkage from protocol requirements to CRF fields, checks, and delivered datasets.

Systematic management of changes to specs, checks, and datasets with history.