What's included

What the plan sets out before testing starts

• Scope and pass/fail criteria for each test object — data entry screens, edit checks, and SAS checks — defined before a single test case is written
• Test case design covering both expected and edge-case data, not just the happy path through each form
• A two-round structure: a first pass to surface issues and a fix-and-retest pass to confirm every one is closed
• Roles and responsibilities for who tests, who fixes, and who signs off on each round
• Traceability from each test case back to its source item in the eCRF/aCRF specification or Data Validation Plan