1.9 KiB
1.9 KiB
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] |