eTRIKS -Standards Starter Pack Standards Guidelines Release 1.1 - 25th April 2016 Authors (by alphabetical order) Bratfalean, Dorina – CDISC Europe Foundation, Braxenthaler, Michael – Roche Innovation Center New York, Houston, Paul – CDISC Europe Foundation (*), Munro, Robin – ID Business Solutions Limited, Richard, Fabien – Centre National de la Recherche Scientifique, Rocca-Serra, Philippe – Oxford e-Research Centre, University of Oxford (*), Romacker, Martin – Roche Innovation Center Basel, Sansone, Susanna-Assunta – Oxford e-Research Centre, University of Oxford. (*) Correspondence to
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[email protected] Version History Version Date Who Role Notes 1.0 11 Philippe Rocca- Draft creator and Draft for internal use February Serra, Fabien maintainer 2015 Richard, Dorina Bratfalean 1.1 25 April Philippe Rocca- maintainer Public release 2016 Serra Licence: https://creativecommons.org/licenses/by-sa/4.0/ 1 A Business Case for Standards in eTRIKS Part 1. Introduction 1.1 eTRIKS mission and objectives 1.2 Document objective 1.3 Intended Audience 1.4 Standard Definition and Typology 1.4.1 Definition of Standards: 1.4.2 Typology of Standards 1.5 Purpose of Standards Part 2. Procedure for standards selection and recommendation 2.1 Procedure outline 2.2 Attributes of standards 2.3 Versioning of Standards 2.4. Standardization Bodies and Service Providers 2.4. Gaps in Standards 2.4.1 Coverage gap in a domain covered by an existing standard 2.4.2 Coverage gap in a domain not covered by standards 2.5 Changes, maintenance and updates to eTRIKS Standard Starter Pack Part 3. Standards in data management 3.1 Standards for Data Security, Data Privacy and Compliance with Ethical Guidelines.