Investigational Product Management: A Critical Review of Practices and Procedures

Description

Page: 256-259

Paramita Choudhuri¹, Shweta Rai², Kuldeep Kumar³, Thilakesh⁴, Shiwani Kumari⁵, Kavin Mahalingam⁶, Adarsh Keshari⁷, and Minakshi⁸ (Ethics Committee Secretariat, Fortis Hospitals Limited, Bannerghatta, Road. Bangalore & Fortis CSR Foundation (Clinical Research Division)¹, Fortis CSR Foundation (Clinical Research Division) and Fortis Healthcare Limited²,³, Trainee Research Coordinator, Fortis Hospitals Limited, Bannerghatta Road, Bangalore⁴,⁶, Clinical Research Coordinator, Fortis Hospitals Limited, Cunningham Road, Bangalore⁵, Clinical Research Coordinator, Fortis Hospitals Limited, Bannerghatta Road, Bangalore⁶, Trainee Research Associate, Fortis Healthcare Limited, Doctor of Pharmacy student at Teerthanker Mahaveer College of Pharmacy, Teerthanker Mahaveer University, Moradabad (UP)⁷, GD Goenka University, Sohna Rural, Haryana⁸)

Effective management of investigational products (IPs) is crucial for the success and integrity of clinical trials. This study provides a comprehensive review of the key processes involved in IP management, including delivery, storage, dispensing, accountability, and destruction. The findings indicate that IPs are typically delivered to the clinical research department, PI’s office, or research pharmacy after ethics committee approval and only authorized study personnel are permitted to receive and verify the shipment contents. Strict storage requirements, including controlled temperature and humidity, as well as continuous monitoring and documentation, are essential to maintain the integrity of the IPs. The study also examines the challenges faced by investigators and research teams in managing IPs, such as addressing deviations in shipment conditions or storage, incomplete documentation, and the proper handling of used, expired, or damaged IPs. By understanding the best practices and potential this study aims to contribute to the development of procedures and guidelines that can enhance the integrity and efficiency of clinical trials, ultimately benefiting patients and advancing medical research.