Radioactive Product Disposal Challenges
| Type of indicator | Risk |
|---|---|
| Risk category | Investigational Medicinal Product (IMP) supply chain |
| Golden KRI | NO |
| Therapeutic area | Oncology |
| IF risk event | Not all of a radioactive investigational product (IMP) is used during treatment administration |
| DUE TO risk causes | Lower-than-expected required dosage, inaccurate dose estimation, or changes in treatment plan |
| THEN risk impact may result | Increased challenges with radioactive waste management, potential safety risks, and non-compliance with radiation disposal regulations |
| Risk indicator | Radioactive product disposal challenges |
| Metric | Percentage of unused radioactive IMP volume |
| Unit | % |
| What level should be measured | Study, country, site |
| Purpose | Ensure the safe, efficient, and compliant disposal of radioactive investigational products by identifying deviations between planned and utilized quantities to prevent environmental or occupational exposure risks. |
| Description | This KRI tracks discrepancies between planned and actual use of radioactive IMPs, highlighting potential inefficiencies or safety risks associated with leftover radioactive material requiring disposal. |
| Formula | ((Planned volume of radioactive IMP ÷ Utilized volume of radioactive IMP) − 1) × 100%. If the result is negative (utilized volume greater than planned), record as 0%. |
| Suggested thresholds - high | 10% |
| Suggested thresholds - medium | 5% |
| Associated metric 1 | Planned volume of radioactive IMP |
| Associated metric 2 | Utilized volume of radioactive IMP |