Sync template from atomicqms-style deployment

Templates/SOP-Template.md

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+# Standard Operating Procedure: [Title]
+
+| Document ID | SOP-XXX |
+|-------------|---------|
+| Title | [Title] |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | [DEPARTMENT] |
+
+---
+
+## 1. Purpose
+
+[State the purpose of this procedure]
+
+## 2. Scope
+
+[Define the scope and applicability - which measures, which studies, which personnel]
+
+## 3. Responsibilities
+
+### 3.1 [Role 1]
+- [Responsibility]
+- [Responsibility]
+
+### 3.2 [Role 2]
+- [Responsibility]
+- [Responsibility]
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| PRO | Patient-Reported Outcome - A measurement based on a report that comes directly from the patient |
+| ClinRO | Clinician-Reported Outcome - A measurement based on a report from a trained healthcare professional |
+| ObsRO | Observer-Reported Outcome - A measurement based on observation by someone other than the patient or healthcare professional |
+| PerfO | Performance Outcome - A measurement based on a standardized task actively undertaken by a patient |
+| MCID | Minimal Clinically Important Difference - The smallest change in outcome that patients perceive as beneficial |
+
+## 5. Procedure
+
+### 5.1 [Section Title]
+
+[Procedure steps]
+
+### 5.2 [Section Title]
+
+[Procedure steps]
+
+## 6. Related Documents
+
+- [List related procedures, forms, validation reports, etc.]
+
+## 7. References
+
+- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
+- FDA-NIH Biomarker Working Group (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource
+- ISPOR Task Force (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures
+- [Additional relevant standards, regulations, publications]
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |