Question: ArrayHow to handle empty bottles of injections used in clinical trials? Destroy and keep records or keep samples for preservation
Answer: The destruction of empty bottles should comply with the provisions of the experimental protocol or drug management manual. Common destruction methods include: 1. Destroy according to the hospital's medical waste disposal process; 2. Return to the applicant's pharmaceutical factory for destruction; 3. Entrust a third party for destruction. But for the destruction of empty bottles, it is usually carried out in hospitals to reduce unnecessary transportation processes, and a written agreement needs to be reached with the hospital before the experiment. No matter where it is destroyed, the unit responsible for destruction should have a qualification certificate and traceable destruction records. It should be noted that many hospitals or applicants carry out large-scale and centralized destruction, and it is necessary to consider in advance how to keep records, identify the destruction time of experimental drugs/bottles, and the quantity of destruction.