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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
[ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials]
Catherine Cornu1, Anne Donche2, Carine Coffre3
1Inserm, CIC1407, hôpital Louis-Pradel, CHU de Lyon, 28, avenue du Doyen-Lépine, 69500 Bron, France; Service de pharmacologie clinique et essais thérapeutiques, CHU de Lyon, 69500 Bron, France; UMR 5558, université de Lyon, 69000 Lyon, France.
Context:
Clinical studies involve an increasing amount of data collection and management. However, there is no specific quality standard sufficiently practical, in free access, and open for data management and the underlying IT-infrastructure in academic units. European Clinical Research Infrastructures Network (ECRIN) published standard requirements for certified data management units. We present a French version of these standards.
Methods:
A group of experts produced the standards, by consensus. The first version was revised after two pilot audits for data centre certification were performed.
Results:
The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general".
Conclusions:
These standards offer a clear description of DM and IT requirements for clinical studies. Initially created for ECRIN certification purposes, they offer a very useful reference for academic DM structures.
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