The PSDM group of the Biometrics Section (BMS) of the Netherlands Society for Statistics and Operations Research (VVS/OR) organised the event
Implementation of CDISC standardization:
Monday September 14th, 2015
15.00 – 18.30 hours
hosted by SAS Institute, Huizen
|15:00||Registration, coffee & tea|
|15:25||Welcome by SAS and PSDM|
|15:30||CDISC and Nutrition (title to be confirmed)
Hanneke Lankheet, Team Leader Data Management,Nutricia Research, The Netherlands
|16:00||The black box of Define.XML
Ilias Pyrnokokis, Junior Health Economist and SAS clinical/statistical programmer,OCS Consulting, The Netherlands
|17:00||CDISC Metadata: Making it work for you
Dave Iberson-Hurst, Owner,Assero Ltd, United Kingdom
|17:30||Visual Approaches for Safety Analysis
Valérie Nedbal, JMP Pharmaceutical Technical Manager Europe,SAS Institute, Germany
|18:00||Panel Discussion – Share your experience and/or ask the experts!|
|18:30||Closing remarks PSDM & Drinks|
Nutrition taking a bite into CDISC
The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, neutral, non-profit standards developing organization that has been working through teams, since its formation in 1997. The aim of CDISC is to develop global standards and innovations to streamline medical research and ensure a link with healthcare. In 2012 CFAST was launched, a program to accelerate the standards in therapeutic areas that are important to public health. To advance the development of data standards for therapeutic areas, several Therapeutic Area User Groups were initiated, e.g. the Alzheimer’s Disease TAUG. In 2015 the TAUG on Nutrition started with several members working in different areas of Nutrition. The goal of the Nutrition TAUG is to ensure the consistent use of existing CDISC standards for clinical research in nutrition and to facilitate the alignment and development of new standards for research in all areas and for all life stages in nutrition.
The Black Box of Define-XML: From Guidelines Straight to Your Browser.
Apart from the submission of electronic clinical study data to the FDA, information which will help to understand the data is also required. The latter deeper level includes the data definition file, metadata which describes the content and the format of the submitted data sets. CDISC sets the standards for such submissions and FDA has adopted its eCTD specifications where the metadata is submitted in the Case Report Tabulation Data Definition Specification (CRT-DDS) format, also known as Define-XML. In this presentation, we will illustrate a technical approach to create Define-XML file efficiently and with validity by combining SAS and Excel technology.
CDISC Metadata: Making it work for you
This talk will focus on pragmatic approaches to using that the new metadata that CDISC is now providing from the SHARE environment and the Therapeutic Area standards programme. This will be based on experience gained from working within pharmaceutical companies, developing tools and developing standards within CDISC teams over the last few years.
Visual Approaches for Safety Analysis and Review of Clinical Trials and Personalized Medicine
- Graphical Patient Profiles driven by CDISC standards
- Visualization of Time Windows linked to Patient Profiles in Clinical Trials
- Link Genomics data to clinical trials
Hanneke completed her MSc in Plant Breeding from Wageningen University. She joined an international program on partial resistance to diseases (in plants) and worked at the International Crops Research Center for the Semi-Arid Tropics to complete her research. She obtained her PhD degree from the Wageningen University. She then worked as a statistician for a Veterinary Contract Research Organisation in The Netherlands. In 2004 she joined Royal Numico as a Data Manager and she became a Team Leader of the Data Management group after Numico was taken over by Danone. In 2013 the Danone R&D division of Early Life Nutrition and Advanced Medical Nutrition was centralized at Utrecht and renamed to Nutricia Research. Hanneke now leads the data management team for the Early Life Nutrition Division. She is a board member of the Association for Clinical Data Management and initiated a CDISC working group on Nutrition.
Ilias Pyrnokokis holds a BSc in Economic Sciences from the University of Patras in Greece and an MSc in Health Economics, Policy and Law from the Erasmus University in Rotterdam, the Netherlands. Ilias is originally from Greece where has worked as an economics analyst before moving the Netherlands in 2011, to obtain his master’s degree and then work as a statistical programmer for OCS Consulting. From a background in economics Ilias smoothly transitioned to a technology focused role, having obtained his SAS Base Programmer certificate and planning to obtain the Advanced Programmer certificate as well. Ilias has had extensive exposure to the pharmaceutical industry, where he has mainly been involved in CDISC related projects.
Dave has over 30 years of industry experience with 15 years in the pharmaceutical industry. For most of those 15 years he has been helping develop and using the CDISC standards.
Dave led CDISC Technical work as for 2.5 years and has led the ODM and SHARE teams andh as worked closely with the FDA, CDISC, HL7, ISO, IHE and other organisations that promote better electronic processes for medical research. He was the lead author for the CDISC white paper of electronic source data that was used as the basis for EMA’s guidance document.
He now is exclusively focused on the effective management and use of metadata within pharmaceutical companies to improve process and data quality.
Valérie Nedbal, serves as JMP Sr. System Engineer for Northern Europe at SAS Institute GmbH in Heidelberg. Prior to SAS Institute, Valérie Nedbal was Senior Field Marketing Manager for LION bioscience AG, a software company offering solutions in the Life Science Market. Valérie Nedbal holds a PhD in Biology from the German Cancer Research Center in Heidelberg, and did post-docs in Max-Delbrueck Center, Berlin-Buch and in European Molecular Biology Laboratory, Heidelberg.