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In a clinical study with biomarker data managed by an external partner, what should be the data flow? Is there an obligation to store these data into the clinical database? Or can they be transfered directly to statistician team? What about the coding or anonymization of these type of data at CRO and at Sponsor?
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In a clinical study with biomarker data managed by an external partner, what should be the data flow? Is there an obligation to store these data into the clinical database? Or can they be transfered directly to statistician team? What about the coding or anonymization of these type of data at CRO and at Sponsor?
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Author:
fabrice.dumaine:
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Posted: 01/18/2011 10:23:03 AM EST
Tags: biomarker | clinical database | anonymization
fabrice.dumaine:
Add as a Colleague
Posted: 01/18/2011 10:23:03 AM EST
Tags: biomarker | clinical database | anonymization
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