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Subject: Re: [Join] CORBEL: representative from OASIS for multi-stakeholder taskforce
CarolBest of luck with your project,Christian,We certainly appreciate the invitation. I've copied Zach Schmidt of SureClinical who chairs the OASIS eTMF Technical Committee. He should be able to find an appropriate representative from the TC.On Fri, Oct 16, 2015 at 7:34 AM, <Christian.Ohmann@med.uni-duesseldorf.de> wrote:Dear Sirs,
we are looking for a representative from the OASIS Electronic Master File (eTMF) Standard TC for our multi-stakeholder patient-level data taskforce to be implemented within the new EU-Project CORBEL. CORBEL (Coordinated Research Infrastructures Building Enduring Life-Science Services) is funded by EU H2020 with around 15 Mill.€ and coordinated by Niklas Blomberg (ELIXIR). CORBEL will establish a collaborative and sustained framework of shared services between the ESFRI Biological & Medical Research Infrastructures.
Within work package 3 of CORBEL there is a working task on "Providing access to patient-level clinical trial data", which will be led by the European Clinical Research Infrastructure Network (ECRIN-ERIC), an ESFRI research infrastructure, providing guidance, consulting and operations management for multinational clinical trials on a not-for-profit basis (see: http://www.ecrin.org) . The objective of this working task is to develop procedures to provide the scientific community with access, upon request, to the patient-level data from previous clinical trials for re-analyses, secondary analyses and meta-analyses and to test them in a pilot/demonstrator.Standardization organisations and bodies are of utmost relevance in this field. We therefore think that we should have representatives from this area in our multi-stakeholder taskforce (e.g. CDISC, ISO, OASIS), covering expertise from meta-analysis, methodology, transparency, funding bodies, industry, patient representative, ethics, data protection, IT and standardization organisations. For your information I have included a short document describing the initiative.We would be happy if an experienced member of your group would be able to join this multi-stakeholder taskforce.If you need any information, please contact me.Kind regardsChristian Ohmann
ECRIN & CORBEL
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