sap-critic

You can audit a clinical trial statistical analysis plan by systematically verifying all 12 ICH E9 required elements and evaluating estimand definitions against ICH E9(R1) standards. This structured review identifies missing data strategies and multiplicity control gaps before database lock.

Estimand framework alignment validates that a clinical trial SAP clearly defines intercurrent events and population summaries according to ICH E9(R1) standards. It ensures treatment effects are precisely specified, preventing ambiguous data interpretation during regulatory submission.

Checking pre-specification rigor involves distinguishing between legitimate confirmatory analysis and post-hoc data-driven decisions within the SAP. This process targets vague language and identifies flexibility that threatens trial validity and research integrity before database lock.

Yes, you can perform a full regulatory compliance audit on an attached statistical analysis plan document. The audit evaluates adherence to ICH E9 and ICH E9(R1) standards, providing a structured verdict on trial integrity and identifying critical regulatory gaps.

Common missing data strategy gaps include failing to clearly define intercurrent events and lacking precise estimand definitions under ICH E9(R1). A structured pre-lock audit identifies these specific gaps in missing data handling and multiplicity control before regulatory submission.

You should not rely solely on an automated SAP audit after database lock has occurred, as it specifically targets pre-specification rigor to prevent post-hoc bias. It functions as a pre-lock verification step rather than a post-hoc data analysis tool.