Regulatory & Documentation
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
The SAP exists to prevent post-hoc analytical choices from biasing the trial result. Regulators (FDA ICH E9, EMA) expect the SAP to be finalized; ideally signed; before unblinding, so any deviation is documented and justified.
SAP authoring is highly templated yet error-prone: misalignment with the protocol's endpoints, inconsistent estimand framing (per ICH E9(R1)), or missing convention specifications can delay regulatory submissions. AI-assisted SAP drafting (Kitsa KScribe) extracts endpoint definitions directly from the protocol, applies estimand templates, and cross-checks every analysis specification against the protocol source-of-truth.
Related terms
Clinical Trial Protocol
A clinical trial protocol is the master document that defines a clinical study's objectives, design, methodology, statistical considerations, and operational conduct, and that all investigators must follow to ensure scientific validity and participant safety.
Endpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
ICH M11 (Common Protocol Template)
ICH M11 is the international harmonized standard, published by the International Council for Harmonisation, that defines a Common Protocol Template (CPT) and machine-readable Technical Specification for clinical trial protocols.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo