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03-14-2008, 05:08 PM
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In Remembrance
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10 Tips to Consider when Planning for Accountability, Reconciliation and Destruction of Clinical Trial Material
http://static.fiercemarkets.com/publ...c/DAR_tips.pdf 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.
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with much love, lou_lou . . by . , on Flickr pd documentary - part 2 and 3 . . Resolve to be tender with the young, compassionate with the aged, sympathetic with the striving, and tolerant with the weak and the wrong. Sometime in your life you will have been all of these. |
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10 Tips to Consider when Planning for Accountability, Reconciliation and Destruction
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