vistatrials.org

VISTA Trials

A web-based CDMS developed by. The European Organisation for Research and Treatment of Cancer (EORTC) is a. Vista Trials is based on international standards and ECRIN requirements. It is. 21 CFR part 11. Vista Trials is GCP and 21CFR part 11 compliant. Vista Trials is validated. Vista Trials is built on CDISC standards. The CDISC mission is to develop and. February 3, 2015 / by Stéphane Lejeune. June 25, 2014 / by Stéphane Lejeune. June 19, 2014 / by Vistatrials.

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VISTA Trials | vistatrials.org Reviews

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A web-based CDMS developed by. The European Organisation for Research and Treatment of Cancer (EORTC) is a. Vista Trials is based on international standards and ECRIN requirements. It is. 21 CFR part 11. Vista Trials is GCP and 21CFR part 11 compliant. Vista Trials is validated. Vista Trials is built on CDISC standards. The CDISC mission is to develop and. February 3, 2015 / by Stéphane Lejeune. June 25, 2014 / by Stéphane Lejeune. June 19, 2014 / by Vistatrials.

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2 clinical data

3 rights and roles

4 trial design

5 reports

6 register your interest

7 eortc

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9 web native

10 cdisc

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VISTA Trials | vistatrials.org Reviews

https://vistatrials.org

A web-based CDMS developed by. The European Organisation for Research and Treatment of Cancer (EORTC) is a. Vista Trials is based on international standards and ECRIN requirements. It is. 21 CFR part 11. Vista Trials is GCP and 21CFR part 11 compliant. Vista Trials is validated. Vista Trials is built on CDISC standards. The CDISC mission is to develop and. February 3, 2015 / by Stéphane Lejeune. June 25, 2014 / by Stéphane Lejeune. June 19, 2014 / by Vistatrials.

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vistatrials.org

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VISTA Trials » 21 CFR part 11

http://www.vistatrials.org/21-cfr-part-11

21 CFR part 11. Vista Trials is GCP and 21CFR part 11 compliant. Vista Trials is validated following a risk based program based on the GAMP5 methodology. 8220;GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems”. Describes a set of principles and procedures that help ensure that software have the required quality. Supported by the European Union 7th Framework Program within ECRIN-IA project.

2

VISTA Trials » CDISC

http://www.vistatrials.org/cdisc

Vista Trials is built on CDISC standards. Mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The Operational Data Model (ODM) is designed to facilitate the archive and interchange of the metadata and clinical data for research and for submission to regulatory body. ODM is the backbone of Vista Trials, facilitating the automation of SDTM and defining XML files production.

3

VISTA Trials » Study Manager

http://www.vistatrials.org/rights-and-roles

Access rights and user management. User roles with predefined rights. Rights granularity per ODM element. To be implemented in VISTA Trials 2.0. To be implemented in VISTA Trials 3.0. Supported by the European Union 7th Framework Program within ECRIN-IA project.

4

VISTA Trials » EORTC

http://www.vistatrials.org/eortc

The European Organisation for Research and Treatment of Cancer (EORTC) is a pioneer in promoting multi-disciplinary cancer clinical research and pan-European collaboration and links a network of more than 2,500 clinicians and scientists in more than 300 hospitals in over 30 countries. EORTC Headquarters in Brussels handles some 30 protocols that are permanently open to patient entry, over 50,000 patients who are in follow-up, and a quality assured database of more than 180,000 patients. EORTC has contrib...

5

VISTA Trials » Category » News

http://www.vistatrials.org/category/news

Pilot version of Vista Trials 1.0 released. The pilot version of VISTA Trials 1.0 was released on the 11 May 2016 after extensive manual and automated testing. As real life testing, the EORTC has started using Vista Trials in a real international clinical trial. Our next milestones are: 21 CFR Part 11 validation August 2016. Complete the full software validation and documentation […]. Posted on May 18, 2016 / Posted by Stéphane Lejeune.

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VISTA Trials

A web-based CDMS developed by. The European Organisation for Research and Treatment of Cancer (EORTC) is a. Vista Trials is based on international standards and ECRIN requirements. It is. 21 CFR part 11. Vista Trials is GCP and 21CFR part 11 compliant. Vista Trials is validated. Vista Trials is built on CDISC standards. The CDISC mission is to develop and. February 3, 2015 / by Stéphane Lejeune. June 25, 2014 / by Stéphane Lejeune. June 19, 2014 / by Vistatrials.

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