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:

kantoor nederland

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