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PSDM Upcoming Events

PSDM Website make-over

The PSDM website has been completely re-designed. See www.psdm.nl instead.

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PSDM board vacancy

The PSDM is currently looking for an additional member to join their board (Data Management area).

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Recent PSDM Event:

Implementation of CDISC standardization - Pragmatic Approaches, Monday 14 Sep 2015,

Program


Abstracts and Bio's 14Sep15 Event

to event page

to abstracts


EFSPI Newsletters

EFSPI Newsletter for August 2015

Other EFSPI Newsletters


abstracts

Abstracts

 

Hanneke Lankheet

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.

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Ilias Pyrnokokis

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.

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Dave Iberson-Hurst

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.

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Valérie Nedbal

Visual Approaches for Safety Analysis and Review of Clinical Trials and Personalized Medicine

  1. Graphical Patient Profiles driven by CDISC standards

  2. Visualization of Time Windows linked to Patient Profiles in Clinical Trials

  3. Link Genomics data to clinical trials

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