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| home > epc > winter 2002 > assessing study feasibility in the netherlands - a research site's point of view |
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European Pharmaceutical Contractor
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Traditionally, sponsors have included feasibility checks in the process of choosing a study site. Sponsors often use standard feasibility forms for individual investigators as well as for SMO-type organisations. The ultimate goal of feasibility checking is to evaluate patient recruitment rate (in other words, number of patients to be randomised in a certain period) and to estimate costs.
In addition to the sponsor's validation of the research site, the site itself is responsible for undertaking a realistic and critical assessment of their resources and the type of study that is being offered, before deciding to accept the study for their research portfolio. The study's requirements and resources should also be assessed as accurately as possible from a regulatory point of view.
Regulation ICH 4.2 demands that an investigator should "be able to demonstrate a potential for recruiting the required number of suitable patients; to have sufficient time to properly conduct and complete the study within the agreed trial period and have an adequate, well informed staff with adequate facilities." When a site moves from participating in one study at a time to several studies simultaneously it has an impact on space, staff, patient recruitment systems and so on.
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