Quality Education: Regulatory Aspects in the Pharmaceutical Industry

Tabusso, G.

doi:10.1177/009286159502900429

Cited by 1 publication

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“…Nevertheless, quality is the leading concept in clinical research, and it is mandatory to reconcile quantity with quality. It is, therefore, essential to define the basic attributes of quality management which are relevant for building quality into a trial (1). It is known that the outcome of a study derives from a multidisciplinary and multifaceted effort involving many players, all of whom contribute to quality in an interactive manner: the sponsor, the CRO, the hospital staff, and the patient (Figure 1).…”

Section: Introductionmentioning

confidence: 99%

Clinical Study Preparation: Sponsor Support for the Quality of Site Management

Cordaro

Tabusso²

2000

Drug Information J

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This paper provides an overview of the role of the sponsor in supporting and improving quality in the conduct of a trial through improved pegormance at the site. Critical issues reside in ensuring standardization of pelformanre at all sites, hence homogeneous and unbiased results. Sponsor responsibilities in this process mainly include preparation of a feasible protocol, care in ensuring that personnel are qualijied and trained, providing a communication and information network, and definition and enforcement of standards. A leading function is played by study monitors whose role is evolving into processmanagers who are no longer confined to data verification. In such a context, the monitor's careful analysis of microactivities at the site substantially facilitates implementation of a system aimed at preventing performance deficiencies and delays.A key to success is commitment to the project by all involved parties, not only the company and the investigator, but also hospital stafi monitors, clinical research organization (CRO) personnel, and patients. The sponsor's support in organizing and coordinating teams with different levels of responsibility, either managerial or operational, facilitates harmonized behavior, integrated communications, recognition of each member's role, and ultimately improved global pegormance and quality.

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Section: Introductionmentioning

confidence: 99%