ClinBuild

Making clinical research more open and accessible

ClinBuild Experience

CDISC Teams

Team Start End
SDTM (SDS) 2013
Questionnaires, Ratings and Scales (QRS) 2013 2018
CDASH 2015
Laboratory Controlled Terminology 2018 2021
 

Foundational Standards

Standard Year
CDASHIG 2.0 and Model 1.0 2017
SDTMIG 3.3 and Model 1.7 2018
SDTMIG 3.4 and Model 2.0 2021
 

CDISC Instructor

Standard Since
CDASH 2019
CT (Co-Trainer) 2019
SDTM 2023
 

Presentations (18)

Event Title Date Location
CDISC UK User Group CDISC Standards Governance: What does JIRA bring to the party? 2016-06-06 Welwyn Garden City, UK
CDISC German Speaking User Group CDASH 2.0 2016-08-09 Berlin, Germany
PhUSE Annual Conference CDASH V2.0: What is it Good For? 2016-10-10 Barcelona, Spain
CDISC UK User Group CDASH 2.0 Organizer 2016-11-07
CDISC UK User Group SDTM & CDASH IG Updates -Volunteer Perspective Organizer 2017-03-08
CDISC European Interchange Submitting QRS (Questionnaires, Ratings and Scales) Controlled Terminology to CDISC Organizer 2017-04-24--28 London, UK
CDISC UK User Group Submitting QRS (Questionnaires, Ratings and Scales) Controlled Terminology to CDISC and QRS Updates Organizer 2017-07-05 Oxford, UK
CDISC UK User Group CDISC PhUSE Roundtable QRS Organizer 2017-10-18
Immunology & Inflammation CDISC Clinical Data Standards for Data Sharing and Regulatory Submissions Poster 2018-02 Berlin, Germany
CDISC European Interchange QRS (Questionnaires, Ratings and Scales) Domain Mappings and UpdatesOrganizerChair: What's New 2018-04-23--27 Berlin, Germany
CDISC European Interchange Handling Multiple Enrollments and Screenings Subjects in SDTM: Are We There Yet? Organizer Chair: End-to-End 2019-05-06--10 Amsterdam, The Netherlands
PhUSE EU Connect Fake it Till you Make it with Global SDTM Laboratory Submissions 2019-11-11 Amsterdam, The Netherlands
CDISC German Speaking User Group Lab Units Representation Team Update 2020-03-11 Munich, Germany
CDISC European Interchange CDASHIG 2.1: CDISC's Best Standard Just Got Better Organizer Chair: Metadata, Foundational II 2020-03-30--04-03 Berlin, Germany
CDISC European Interchange Virtual Conference Organizer Chair: Foundational II 2020-04-01--04-02
SCDM EMEA Virtual Conference Designing Direct Data Capture CRFs using CDISC CDASH 2020-09-15
7th Italian CDISC User Group Network Annual Meeting Updates on Handling Multiple Enrollments and Screenings Subjects in SDTM Invited Speaker 2020-10-07
CDISC European Interchange Incorporating the FDA BIMO and TransCelerate Guidance on Protocol Deviations into the DV Domain Co-presenting: Daniil TeplitskiiOrganizer Chair: COVID-19 Topics 2021-04-28--30 Virtual
CDISC European Interchange CDASH at Scale Organizer Chair: Open Source 2022-04-28--30 Virtual
CDISC European Interchange Organizer Chair: Foundational Part 1 + 2 2023-04-26--27 Copenhagen, Denmark
CDISC + TMF European Interchange Submitting Laboratory Data in Multiple Standard Units Organizer Chair: COSA 2024-04-24--25 Berlin, Germany
 

CDISC User Community

Team Start End
UK User Group 2016 2018
Europe CDISC Coordinating Committee (E3C) 2016
 

CDISC/PhUSE Projects

Team Project Start End
SDTM Unknown and Missing Data Working Party; extension to --STAT variable ND codelist 2016 2017
SDTM Multiple Disposition Events within an EPOCH and Multiple Informed Consents 2016 2017
PhUSE Future Forum Interoperability & Technology Team 2017 2018
SDTM & Lab CT Lab Units Representation Team (Lead) 2018
SDTM Multiple Subject Instances 2018 2022
PhUSE Open Source Technologies in Clinical Research Team 2019 2021
SDTM Protocol Deviations (Co-Lead) 2020
 

Publications

Type Name Year
QRS Generalized Anxiety Disorder (GAD-7) V1.0 2014
QRS Revised Fibromyalgia Impact Questionnaire (FIQR) V1.0 2014
QRS Hospital Anxiety and Depression Scale (HADS) V1.0 2014
QRS Neuropathic Pain Scale NPS V1.0 2014
TAUG Malaria Therapeutic Area User Guide 1.0 2017
Article The Organisation for Professionals in Regulatory Affairs Stakeholders input into EU standards for data sharing 2021
Journal mdi - Forum der Medizin_Dokumentation und Medizin_Informatik CDISC CDASH for CRF Design and Standardization 2023
Journal Journal of the Society for Clinical Data Management Feasibility Assessment of Using CDISC Data Standards for in vivo and in silico Medical Device Trials. Aydin B, Kiely É, Ohmann C. 2023

Recognition

CDISC Volunteer Spotlight Q4 2016