Clinical Trials & Study Documents
Clinical trial documents from protocol to report: estimands, statistical analysis plans, protocol review, clinical study reports and clinical data reconciliation.
6 articles
- What Is an Estimand? The ICH E9(R1) Framework Explained Estimand meaning, the ICH E9(R1) framework, the five intercurrent-event strategies, and how estimands differ from estimates, estimators and endpoints.
- Statistical Analysis Plan (SAP) for Clinical Trials: Contents, Template and Review What a statistical analysis plan for a clinical trial must contain, when to finalize it, ClinicalTrials.gov posting rules, and a review checklist.
- Clinical Trial Protocol Review: Process, Checklist and IRB Expectations How to review a clinical trial protocol in 2026: ICH E6(R3), M11 and SPIRIT 2025 expectations, IRB approval criteria, and a practical checklist.
- Systematic and Scoping Review Protocols: PROSPERO, OSF and Templates How to write and register a systematic or scoping review protocol: PRISMA-P items, PROSPERO eligibility, OSF and JBI options, plus a review checklist.
- ICH E3 and the Clinical Study Report (CSR): Structure, Content and 2026 Status ICH E3 explained: the 16 CSR sections, synopsis length, protocol deviations, narratives, appendices, current status and 2026 submission and disclosure.
- Data Reconciliation in Clinical Data Management: SAE, Lab and External Data How SAE, lab and vendor data reconciliation work in clinical data management: what to compare, when, who owns it, and what to check before database lock.
Subjects covered
- estimand
- ICH E9(R1)
- estimand framework
- statistical analysis plan
- SAP clinical trial
- statistical analysis plan template
- clinical trial protocol
- clinical trial protocol review
- protocol review checklist
- IRB protocol review
- ICH E6(R3)
- clinical study report