Investigational Products (IPs) encompass pharmaceuticals, biologics, medical devices, and other interventions undergoing evaluation in clinical trials. IP accountability refers to the processes and protocols implemented to ensure the proper handling, administration, and documentation of investigational products throughout the course of a clinical trial. Key aspects of IP accountability include:
- Receipt, storage, and inventory management of investigational products
- Dispensing and administration procedures according to protocol requirements
- Documentation of drug accountability records, including receipt, dispensation, and return of unused products
- Monitoring and reporting of adverse events and safety-related issues associated with investigational products