This learning resource is linked to the ARR and NNT / NNH Calculator.
Use the ARR and NNT / NNH Calculator
Regulatory Context
Use comparable adverse-event risks over the same follow-up period. NNT/NNH is rounded up; no confidence intervals or treatment recommendation. The applicable expectation depends on the product, process, market, dosage form, risk, and approved site procedure.
Key Compliance Principles
- Use a scientifically justified and approved method.
- Maintain traceable source data and calculation records.
- Apply risk-based review where the result affects quality or patient safety.
- Confirm the current version of applicable guidance.
- Document deviations from the standard method.
Regulatory and Technical References
Confirm the current applicable version and your site procedure before using the result in regulated work.