Upcoming PSDM event March 20, 2018: Overview of CDASH and introduction to the new CDASHIG 2.0
CDASH defines standards for clinical data collection and ensures that SDTM mapping is a smooth process. Correct CDASH implementation is therefore a crucial part of CRF design. The upcoming CDASHIG 2.0 extends this standardization, adds domain metadata and integrates the CDASH 1.1 standard with the CDASH user guide. During the event, you will be presented with an overview of CDASH combined with practical implementation tips, as well as a brief look to the upcoming changes.
Intro & abstracts
Jules van der Zalm, Manager at OCS Life Sciences and former PhUSE Annual Conference Chair.
Jules combines a strong technical background with a joy to connect with people. In his role Jules is responsible for the execution and delivery of all CRO, project, and training activities that OCS undertakes for its clients in life sciences.
On March 20, Jules is the first presenter at our CDASH event and will give us an upside down overview of CDISC standards; his presentation starts with ‘what do we need these standards for?’ and will lead us from study reporting to ADaM and SDTM and all the way down to CDASH.
Judith Goud, Principal Solution Consultant for Metadata Management at Nurocor.
Nurocor delivers metadata repository services for clinical research. Amongst others; a solution including CDISC standards that can import a client’s custom standards. Standards management and mapping from client to CDISC standards.
Judith presents the CDASH standard. Why should you use the CDASH standard? A bit of CDASH history. CDASH to SDTM. And, of course, the new CDASHIG 2.0. What’s new? And what must not be overlooked when implementing this CDASHIG 2.0?
Elsbeth Verdonk, Team Leader Data Management, Advanced Medical Nutrition, Danone Nutricia Research.
Since 2007, Nutricia is part of DANONE – the group holds top positions in healthy foodthrough 4 businesses: Fresh Dairy Products, Waters,Early Life Nutrition, and Medical Nutrition. Nutricia Research is the R&D organisation behind Nutricia’s Early Life Nutrition and Advanced Medical Nutrition to help individuals build, to establish and to preserve health capital during early life and later in life, and during specific life stages.
Elsbeth will present which CDICS standards they’ve implemented and how CDISC standard are not always suitable for nutrition studies because the terminology differs or the areas are different compared to pharma. Within nutrition you do not have for example a drug under investigation, you investigate a nutrition product instead. Like product accountability instead of drug accountability. Grey areas like these makes it sometimes a challenge to work with CDISC. This is also a reason that within CDISC a Specific Therapeutic Area is created for Nutrition.
In summary, an interesting case study about how Nutricia works with CDISC structures (SDTM, CDASH).
Event agenda
Event fee: 50 euros.
Registration as of 14:30.
Start of the CDASH event at 15:00 hours.
This event will end around 19:00 hours.
| as of 14:30 Coffee/tea and a small bite | ||
| 15:00 hours: Welcome | Frank Beerlage | SAS |
| 15:15 Jaarvergadering PSDM | Egbert Biesheuvel | Nutricia Research |
| 15:35 How do you do CDASH? Interactive session | Alexander Adema | QPS Netherlands |
| 15:55 CDISC overview | Jules van der Zalm | OCS Life Sciences |
| 16:25 CDASH inside out & CDASHIG 2.0 | Judith Goud | Nurocor |
| 16:55 Juices and a small bite | ||
| 17:15 CDASH case | Tineke Piersma | PRA |
| 17:45 CDASH case | Elsbeth Verdonk | Nutricia Research |
| 18:15 Drinks and Indian buffet |
Please register via the password protected PSDM CDASH event registration page by clicking this link: TO THE REGISTRATION PAGE .
The password you are requested is the answer to the sum of 8 and 6.
(To protect us receiving bot registrations.)
The PSDM CDASH event is hosted by SAS, Huizen:
Link to route description SAS, Huizen
Navigation address: Flevolaan 69, Huizen
Please register via the password protected PSDM CDASH event registration page by clicking this link: TO THE REGISTRATION PAGE .
The password you are requested is the answer to the sum of 8 and 6.
(To protect us receiving bot registrations.)
– – –
Upcoming joint EFSPI/PSDM event March 23, 2018: Recent Advances in Clinical Trial Design
Which will be a highly interactive event with well known speakers from academia, regulatory agencies and industry. More information can be found on the EFSPI website
Read more: EFSPI website
EVENTS 2017
Date |
Title |
| 2017 June 23 |
EFSPI/PSDM Meeting “Analysis of Safety Data in Clinical Trials” Astellas, Leiden, The Netherlands |
EVENTS 2016
Date |
Title |
| 2016 December 12016 June 24 |
PSDM Event “Data Sharing” Abott, Weesp, The NetherlandsEFSPI/PSDM Meeting “Biomarkers and Subgroups” Astellas, Leiden, The Netherlands |
EVENTS 2015
Date |
Title |
| 2015 September 14 |
Implementation of CDISC Standardization SAS Institute, Huizen |
PREVIOUS EVENTS
Date |
Title |
| 2013 September 02 |
Risk-based Monitoring: opportunities and challenges in clinical development Astellas, Leiden |
| 2012 November 08 |
Adaptive Designs in Drug Development Workshop MSD, Oss |
| 2012 June 19 |
Open Source Software in Clinical Research: cost-saving opportunity or high-risk solution? Julius Clinical Research B.V., Zeist |
| 2011 November 18 |
European Statistical Meeting Advances in the Treatment of Missing Data Bristol-Myers Squibb, Brussels |
| 2011 June 22 |
The Future of PSDM Disciplines Abbott, Weesp |
| 2010 November 25 |
Statistical and Practical Issues of Patient Reported Outcomes (PROs) (including annual PSDM meeting) MSD, Oss |
| 2009 June 26 |
SETTING EQUIVALENCE MARGINS IN CLINICAL RESEARCH (including annual PSDM meeting) Danone Research, Wageningen |
ARCHIVE
Date |
Title |
| November 28th, 2008 | Program Validation Issues in Clinical Research How to validate clinical databases and one-shot programs Schering-Plough Corporation, Oss |
| 2008 May 22 |
SAE Data Reconciliation: What’s your approach? Solvay, Weesp |
| 2007 November 22 |
EDC: EXPERIENCES AND BEST PRACTICES Xendo, Groningen |
| 2007 October 02 |
PHARMACOVIGILANCE: THE CHANGING LANDSCAPE FIGON Dutch Medicine Days 2007 De Werelt, Lunteren |
| 2007 April 17-18 |
PSDM/PSI Course: Interim analysis and adaptive designs no link to summary yet Organon, Oss |
| 2007 March 07 |
CDISC: Refresh your knowledge of the CDISC basic models Implementation of the models: strategies and stories Organon, Oss |
| 2006 June 21 |
Statistical and Data Management aspects of dealing with Data Safety Monitoring Boards (including annual PSDM meeting) Solvay, Weesp |
| 2006 February 09 |
EDC Workshop Astellas, Leiderdorp |
| 2005 November 29 |
Autumn meeting BMS/ANED (incl. PSDM) Utrecht |
| 2005 June 15 |
PSDM Workshop: How to improve efficiency and quality within Clinical Data Management Amsterdam archief/2005/20050615-2.htm |
| 2005 February 3 |
PSDM Workshop: Recent draft ICH/ CPMP Guidelines revisited Leiderdorp archief/2005/20050203.htm |
| 2004 May 26 |
PSDM Workshop: Where Data Management and Statistics Meet Oss archief/2004/20040526a.htm |
| 2003 December 2 |
SBS/BVS/PSDM Workshop: Challenges for the next 10 years in Biostatistics Beerse archief/2003/20031202.htm |
| 2003 November 20-21 |
PSDM Course: Survival Analysis Oss archief/2003/20031120.htm |
| 2003 June 10 |
PSDM Workshop on CDISC Weesp archief/2003/20030610.htm |
| 2002 November 1 |
PSDM Workshop: Practical Issues on Statistics and Data Management Oss archief/2002/01112002.htm |
| 2001 November 27-28 |
Cursus Mixed Models in Clinical Research Oss archief/2001/27112001.htm |
| 2001 October 11 |
Regulatory Guidelines & Clinical Statistics Weesp html archief/2001/11102001.htm |
| 2001 October 04 |
Data Management: System Validation & Guidelines CHIRON BV, Amsterdam info, program html archief/2001/04102001.htm |
| 2000 December 14 |
Clinical Data Base Management Systems & Electronic Submissions Weesp html archief/2000/14122000.htm |
| 1997 January 23/24 |
”Modelling Categorical Data” Cursus met docenten van Reading University |
| 1996 | Annual report 1996 |
| 1996 | Foundation PSDM during BMS year meeting |
