Re: [Join] CORBEL: representative from OASIS for multi-stakeholder taskf

Subject: Re: [Join] CORBEL: representative from OASIS for multi-stakeholder taskforce

Hi Carol, thanks for this email introduction to Christian Ohmann.

Christian - a pleasure to meet you and thank you for reaching out to OASIS and the OASIS eTMF Standard TC.

I'm cc'ing our TC on your email and document for review and consideration by the TC.

I'll personally review the initiative as well to learn more and we will discuss it at our next TC meeting on Mon Nov 2.

Feel free to reach out to me for further questions re: eTMF. For membership questions, please contact OASIS membership services.

Best Regards,

Zack Schmidt, Chair

OASIS eTMF Standard TC

Zack Schmidt, CEO
SureClinical

2865 Sunrise Blvd Suite 220
Rancho Cordova, CA 95742

zs@SureClinical.net

www.SureClinical.com

Support: 916-265-2000

Direct: 916-265-2004

Top 30 Life Science Startups in the US

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On Fri, Oct 16, 2015 at 6:00 AM, Carol Geyer <carol.geyer@oasis-open.org> wrote:

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.

Best of luck with your project,
Carol

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 regards

Christian Ohmann
ECRIN & CORBEL

--
Carol Geyer
Senior Director, OASIS
www.oasis-open.org
+1.941.284.0403