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Published byGwen Sherman Modified over 9 years ago
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PURE Argentine Current status Andres Orlandini Dubai 2006
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Timelines Pilot Translations Regulatory approvals Plan the logistics Funding searching 2003 2004 2005 2006 2007 2008 2018 /2019 Importations CRF printing Recruitment Final follow upInterim follow up
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URBAN(48) Rosario (1,000,000 subjects) 10 day work Data collected at IIC Team: 4 members (1 MD, 1 Biochemist, 2 Study Coordinators) PURE ARGENTINA Pilot Study Recruitment RURAL(44) B. Irigoyen (2,200 subjects) 100 km from Rosario Local authorities support 3 day work Data collected at a Health Care Center Team: (1 MD, 1 biochemist, 3 Study Coordinator, 1 nutricionist)
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Pilot experience People came alone, eventually in couples, both in urban and rural settings. URBAN SAMPLE MEAN AGE MEN: 50 MEAN AGE WOMEN: 57 RURAL SAMPLE MEAN AGE MEN: 50 MEAN AGE WOMEN: 52
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Pilot experience Lessons learned Too long questionnaires (3 hs. to complete the visit) Rural subjects needed more assistance than urban subjects Family Census Q.: Rural subjects were not able to provide contact person Adult Q.: Unclear definition of ethnic origin
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Organizational chart National Coordinator Rafael Diaz ECLA A.Orlandini-E.Paolasso COM A.Pascual SC G.Niemann PI N.Maldonado Nut S.Del Cerro Nurse Data entry Urban Rural (*5) Local officeIIC Local Physician Nurse Field workers 2 supervisors 5 assistants
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Pure full scale Urban City: Rosario Center: Instituto de Investigaciones Clinicas Population:1.011.642 habitants Area:117 km2 Blocks: 6.306
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Pure full scale Urban a) 3 neighborhoods –Middle classEchesortu3300 households –High class Martin1100 households –Low class JJ Paso1200 households b) local industry –Paladini SA –1380 employers (Villa Gobernador Galves) –80 % men –Age 18-65 (x32)
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Pure full scale Rural Santa Fe State –5 villages –Less than 2000 inhabitants (definition of rural in Argentina) –Between 50 and 100 km from Rosario
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Logistics Urban Census 2 subjects IIC Icon PE and Q Blood sample collection (-) 70 storage Rural Census 3 subjects Local offices Icon PE and Q Blood sample collection and processing
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Pure full scale Funding Support for local private companies (50.000 US$) have been already obtained Additional support is being searched
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