The key functions for our clinical trial supplies include:
- Ensuring that appropriate import/export requirements are met
- Actively managing the labeling process for drug supplies
- Defining, executing and controlling a suitable drug storage and distribution system
- Closely monitoring supply couriers to maintain schedules and performance
- Day-to-day monitoring of inventory stocks along the entire supply chain—from local depots and investigational sites
- Continually evaluating logistics and supply data to strengthen and refine strategies
- Ensuring a suitable return and destruction system, including managing the collection of all relevant documentation to minimize patient and sponsor risks
Guidance for Disposal of Drugs Used in Clinical Research
Expectation: Any used or unused investigational medications are to be destroyed in accordance with the guidelines and with standards set up by industry sponsors.
Used refers to study medications used in clinical research dispensed to research participants and returned to research team.
Unused refers to study medications never dispensed to research participants but that remain in stock at study conclusion.
Why is this important?
To ensure the safety of trial patients, visitors and staff in the Medical Center and the environment.
What do we need?
Procedure for destruction of used and unused investigational medications (empty or partially empty bottles or vials).