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August 2011


Rebecca York

Good Clinical Practice: From Review to Application

by Rebecca York
Clinical Research Associate, IMARC Research

As clinical research professionals, we often hear phrases like, "It's in the regs!" Or, "It's GCP!" At times, it may seem as though by classifying our actions as "GCP," we wave a magic wand that ensures regulatory compliance. But what is GCP, and what does it mean to be GCP compliant? In order to take "good" to "great," it is important to understand the conceptual framework that supports good clinical practice and be able to apply that understanding in daily research practice.

Good clinical practice is an attitude of credible excellence in research that provides a standard for clinical study design, implementation, conduct and analysis. Good clinical practice is more than any one document; rather, it is a collective compilation of many thoughts, ideas and learning moments spanning the globe over. Furthermore, good clinical practice is a mindset that is absolutely essential to the protection of patients' rights and the assurance of data integrity.

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Melissa Smith

Transfer Comparability and Co-validation

by Melissa Smith
Founder and Principal Consultant for MJQuality Solutions, LLC

The USP (United States Pharmacopeia) has proposed a new General Information chapter published in the PF volume 35 (September-October 2009). The USP defines transfer of an analytical procedure as "the documented process that qualifies a laboratory (a receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit also named the sending unit) ". The USP details several categories of transfer-comparative testing: co-validation, method verification or revalidation, and transfer waivers. The stimuli article also reviews the procedural elements that are recommended for successful transfer. Of these elements, a preapproved protocol is required. The basic content of the protocol is described as well as the process of reviewing the analytical procedure prior to the transfer. There is also a brief paragraph on the contents of the method transfer report and there is reference to statistical approaches for what USP refers to as statistically similar comparability of comparison of procedures, published in USP PF volume 35. The stimuli to the revision is open for comment and can be found on the USP website. This USP stimuli to the revision provides a good basic structure for the transfer process.

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Did you know that seven pharmaceutical companies submitted a joint citizen petition asking the FDA for clarification regarding off-label use manufacturer-communications? A recent blog post written by attorney Dara Katcher Levy describes a citizen petition that was recently submitted by seven pharmaceutical companies requesting more clarification regarding off-label use manufacturer-communications.
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