10 Tips to Consider when Planning for Accountability, Reconciliation and Destruction of Clinical Trial Material

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Monica English* and Amy Ma, PhD
Introduction

All experimental compounds tested in humans during clinical development are under stringent control to ensure that these drugs are administered only to eligible patients participating in approved study protocols. To that end, regulatory agencies worldwide mandate that all investigational products manufactured for clinical trials must have cradle-to-grave tracking for accountability, reconciliation, and destruction.
The lifecycle of investigational product (IP) is complex, transitioning from a manufacturing environment during production to a clinical environment during experimentation. Each of these situations has a unique body of governing regulations, Good Manufacturing Practice (GMP) or Good Clinical Practice (GCP), respectively. Additionally, IP reverts back to GMP when accounted, reconciled, stored, and packed for destruction as waste, creating an additional transfer between these environments. It is critical that you be able to document and demonstrate to regulatory authorities that you are in complete control of the drug supply chain at all times and can account for the whereabouts of all manufactured investigational product, whether consumed or destroyed.

Currently the administrative burden of accounting for and reconciling clinical supplies rests largely on the investigative sites, monitors, and depots who generally perform these tasks manually and without the benefit of a central tool that tracks clinical material from manufacture to dispensation and return [1]. You can reduce this burden and streamline the process by considering and implementing these 10 easy tips, that will ultimately save money, minimize errors, and more efficiently reconcile all IP at study closeout per regulatory requirements.

Conclusion
By following these 10 easy tips, you will be able to address all your major accountability, reconciliation and destruction issues before your trial even starts. Investing in proactive study planning with early consideration of endgame activities can save time and reduce the risk of cost overruns. While it is often difficult to establish concrete plans while a protocol is still being developed, thoughtful planning and consideration in conjunction with the clinical study manager and clinical supply manager can prevent the surprises of unforeseen tasks and hidden costs. Leveraging readily available tools such as IVRS not only during the study itself but after the last patient out can streamline many labor-intensive activities and minimize errors.
Reference
1.
Dowlman, N., Kwak, M, Wood, R, Nicholls, G. “Managing the Drug Supply Chain with eProcesses,” Applied Clinical Trials, 15 (7):40-45 (2006).
Monica English and Amy Ma are Project Managers with Covance IVRS, 210 Carnegie Center, Princeton, NJ 08540, (609) 452-8550.

*To whom all correspondence should be addressed, email monica.english@covance. co