The Statistical Analysis Plan (SAP) & Table Mock Shells
The master roadmap that guides all clinical programming, derivation rules, and TLF formatting.
📌 Direct Answer / Executive Definition
The Statistical Analysis Plan (SAP) is a formal technical document that details the principal statistical methods, primary/secondary efficacy endpoints, safety evaluation rules, population definitions (ITT, Per-Protocol, Safety), and mock table shells to be generated for the Clinical Study Report (CSR).
Why Pre-Locked SAP Specifications Matter for Regulatory Compliance
Programmers must never derive variables or format tables arbitrarily. Every column, precision rule, and subgroup must strictly align with the SAP approved before database lock.
Standard Syntax, Derivation & Framework Pattern
/* Applying SAP Population Flag (Safety Analysis Set) */
DATA work.adsl_pop;
SET work.adsl;
/* SAP Rule: Enrolled, randomized, and took >= 1 dose of investigational product */
IF ENRLFL='Y' AND RANDFL='Y' AND TRT01P NE '' THEN SAFFL='Y';
ELSE SAFFL='N';
RUN;Core Rules & Certification Takeaways
- The SAP is finalized and signed off *prior* to database lock and unblinding to prevent statistical bias.
- Mock Table Shells specify exact titles, column headers, decimal precision (Mean, SD, Median, Min, Max), and footnote text.
- Analysis populations typically include ITT (Intent-to-Treat), mITT (Modified ITT), Safety, and PK (Pharmacokinetic) populations.
- Any deviation from the SAP must be documented in the final Clinical Study Report (CSR).
🔗 Related Architectural Concepts & Next Steps
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Frequently Asked Questions (FAQ)
When must the Statistical Analysis Plan (SAP) be locked?
The SAP must be locked and signed off prior to breaking the study blind and locking the clinical database.
What are Mock Table Shells?
Mock shells are visual template layouts (with placeholder headers and footnote definitions) that specify exactly how final clinical summary tables and figures must appear.
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