Program of events is subject to change.

2021 CDISC TechniCon

13:00 - 17:30, Central Europe Time (CET)
All times shown are in Central Europe Time (CET)

13:00 - 13:30

Mapping EHR Data to EDC - A Case Study

Suchitra Ramaswamy, Zifo RnD Solutions

Qurie – Our SDTM Bot : Studies are becoming more complex in terms of design and SDTM submission is being made mandatory across different regulatory authorities. At surface level this would automatically mean a need for more SDTM experts. But if we take a closer look, we realize that there is only some truth in this and lot of SDTM mappings can be automated by applying machine learning and natural language processing. There are lots of patterns in the data that can be taken advantage of. Based on this thought we designed a self-learning bot which reads CRF data and predicts SDTM mapping. Just like humans, this bot is designed to self-learn as and when new mappings are encountered. This bot will greatly reduce the time spent on SDTM mappings thereby allowing the experts to concentrate on complex mappings and increasing the number of studies they can handle in parallel. 

The bot will greatly reduces the time spent on SDTM mappings thereby allowing the experts to concentrate on complex mappings and increasing the number of studies they can handle in parallel. As the bot self-learns SDTM mapping, there is high level of consistency and predictability in which SDTM variable input data is mapped. Experience bias is reduced.

13:30 - 14:00

System Automation for CDISC Standards: SDTM-ETL

Dr. Jozef Aerts, XML4Pharma

SDTM-ETL is a mapping software to generate SDTM and SEND submissions, including the supporting define.xml, starting from operational data in ODM format. Most of the mappings can be generated using a combination of drag-and-drop and wizards, resulting in mapping scripts that can further be refined. The mapping scripts are in an easy-to-learn, intuitive language, with many functions, including the use of RESTful web services such as the CDISC Library and those from the NLM and the FDA itself, and automated "US conventional" to "SI" unit conversion. It supports all newer versions of the SDTMIG (3.1.2, 3.2, 3.3) and SENDIG (3.0, 3.1) and both Define-XML 2.0 and 2.1. As far as we know, this is the first software implementing the Define-XML v.2.1 standard.

Datasets can be generated in either SAS-XPT or the modern CDISC-Dataset-XML format. 
For users that do not have the operational data available in CDISC ODM format, an add-on is available to transform operational datasets in XPT, Excel or CSV format to CDISC ODM.

In SDTM-ETL, as the mapping starts from a template define.xml for the selected SDTM/SEND-IG, and this underlying define.xml automatically updates with every change in the mapping, the software implements the "best practice" of using the define.xml as the "specification". This allows to have a very high quality define.xml. The usual practice of generating the define.xml "post-SDTM/SEND" usually leads to a low-quality define.xml, which are hard to use by regulatory reviewers. The use of the CDISC Library API takes care that correct usage of SDTM/SEND variables and CDISC-CT is ensured during the mapping process. The use of the "Open Rules for CDISC Standards", and integrated validation, supported by the use of the CDISC Library, makes it easy to generate high quality datasets. The software further encourages the use of mappings for new studies, as all the mappings are stored within the define.xml itself, and can easily be reused in another study.

14:00 - 14:30

System Automation for CDISC Standards: A3 MDR

Dave Iberson-Hurst, Kirsten Langendorf and Johannes Ulander, S-cubed

The offering is a tool for the management of clinical study standards, their deployment within a sponsor organisation and the generation of study metadata definitions based on those definitions so as to increase end-to-end automation. The offering employs linked data so as to break down silos across the pools of definitions experienced by industry today and is designed to remove the need for mapping.

The offering is built around the idea of linked data implementing Biomedical Concepts (BCs), the CDISC standards and other necessary entities combined with a single model that links the various CDISC artefacts into one consistent view of the world. This model removes silos and allows for a seamless automated processes to support the creation of clinical studies.

The offering supports the generation of the necessary submission items incl. CRF/aCRF, define.xml (including Value Level Metadata) and supports the automated creation of SDTM datasets. These can also be used as data specifications for providers who supply study data to sponsors. Additionally, the definitions necessary for study setup such as the Schedule of Assessments, Forms via exports in standard formats such as CDISC ODM and vendor formats such as Medidata ALS can also be generated.

All of this can be achieved with full traceability using the linked data approach. The tool is a SaaS solution running in the cloud and employs a modern user interface providing an excellent user experience.

The offering is designed to meet the combined aims of the CDISC´s 360 and Transcelerate´s Digital Data Flow projects.

The product supports the reduction of heterogeneity of implementations by making consistent use of definitions across studies. The core of this is the use of BCs to ensure this consistency. There is no magic, it is simply a clear and focused approach to the problem space. As part of the technicon we would like to show this support in action by:

  • Creation of new BC via the use of templates to guide the user in creating high quality definitions

  • Associate BCs with SDTM domains to allow users to focus on the more important facets of their work

  • Build multiple forms from the same BC library to show the consistent application of data definitions

  • Build forms based on BCs and more traditional questions showing that the two approaches can be used in parallel

  • Auto annotate forms based on the above BCs

  • Show how BCs can be used with multiple domains to support their use with therapeutic areas and the associated user guides

  • Show how Therapeutic Area User Guides can be implemented electronically using BCs along with associated CRFs and terminology

  • Export the above content to useful formats for such that users can take advantage of the improved definitions and use them in current processes within sponsor organisations

14:30 - 15:00

How to Comply with CDISC Standards in Clinical Trial Design and Build

Ed Chappell, Formedix

The presentation will provide an overview of the CDISC standards required for clinical trial submission to regulatory authorities. The demo will also show how the Formedix platform supports CDISC compliant clinical trial design and build. 
Topics include:

  • The CDISC standards required for regulatory submissions.

  • What the main focus points of CDISC implementations should be.

  • Why CDISC compliancy should be built in right at the start of a study rather than being left until the end.

  • How to simplify the management of studies and metadata.

  • The benefits of reusing standardized content across studies.

  • Generating visualizations and metadata specifications, such as:

  • Visit structures

  • eCRF previews

  • Annotated CRFs

  • Edit check specs 

  • EDC specs 

  • SDTM specs

  • Mapping specs

  • Multiple EDC design and build from a central platform.

  • Generating annotated CRFs using built-in automated processes.

  • Using APIs for the setup and automatic execution of automated SDTM data conversions. 

  • Generating compliant SDTM define.xml and ADaM Define.xml. 

  • Using built-in validation to check CRF designs, EDC designs, and CDISC conformance.

The presentation will also cover how Formedix is used for the development of CDASH CRF forms for the CRF library project.

Formedix provides a centralized, cloud-based clinical trial study automation platform and clinical metadata repository. It helps companies that are conducting clinical trials to design, build, and submit CDISC compliant clinical studies from one central platform. 
Our fully integrated clinical metadata repository simplifies the study design process. It lets companies store metadata content and build studies quickly using automated workflows. It includes features such as impact analysis, change management, traceability, and governance. It has the automated processes needed to generate the study deliverables required to make a submission to the FDA.
In summary, organizations can:

  • Store, manage, and reuse metadata across the end-to-end life cycle of their studies. They can create metadata content from scratch, or upload existing organizational standards.

  • Manage their organizational standards, helping to increase data quality while decreasing downstream costs.

  • Make validated CRF designs, EDC designs, and builds.

  • View various metadata formats such as seeing how CRFs look and work in 7 leading EDC systems, mapping specifications, edit check specifications, visit structure specifications, CRF specifications, SAS XPT and SAS v9 clinical views.

  • Generate submission ready annotated CRFs in PDF format.

  • Convert data to produce validated SDTM datasets.

  • Generate valid SDTM and ADaM define.xml files for submission.

  • Use the APIs to integrate with external systems.

  • Generate define.xml from SAS XPT files or old legacy datasets. 

Our platform supports previous and current versions of CDISC standards. It is kept updated in line with new CDISC and NCI standards. 
Formedix APIs allow integration with organizations own internal systems. This allows the set-up of automatic processes to push source data into Formedix and trigger a conversion. Then, pull the datasets back into the internal system from Formedix. You can also pull metadata in ODM and Define-XML formats.
Formedix has been a member of CDISC since 2000 and helped with the development of ODM, Define-XML and Dataset-XML. We have also been involved in the CDASH CRF library and helping to deliver the end to end automation vision of CDISC 360 by providing content in a machine-readable, standardized CDISC ODM format.

15:00- 15:30

CDISC Library Browser

Dmitry Kolosov, PAREXEL

There are several CDISC Library Browsers based on the CDISC Library API, which are currently adapted for a desktop usage. The main goal of this project is to show how CDISC Library API can be used to access the standards on mobile devices.

I have built a CDISC Library Browser for desktop as a part of Visual Define-XML Editor. It became an essential part of my working tools as I frequently check standards when developing specifications in my company. It helps to quickly find required variables and their descriptions, download NCI/CDISC Controlled Terminologies and copy information from the standards. This project will allow to access the same information on mobile devices. 

15:30 - 16:00

System Automation for CDISC Standards: elluminate®

Sam Anwar, eClinical Solutions; and Bob O'Connor, Agios Pharmaceuticals

elluminate® is a clinical data platform that provides one unified platform for all clinical data, from acquisition through analytics. The platform delivers self-service access to data ingestion, mapping and comprehensive analytics so that teams can answer clinical and operational questions with speed and accuracy. elluminate provides a clinical data repository and integrated platform of products: Mapper, for powerful data transformation, unification and automation from diverse sources and formats; Data Central, a central hub and clinical data workbench that enables review of listings, patient profiles, analytics, queries and issue management; Clinical Analytics, providing comprehensive visualizations and reporting to support efficacy decisions and cross-trial operational analytics for proactive trial management; and Risk-Based Monitoring, for insights across data sources that identify, track and mitigate operational risks including site performance. 

elluminate® from eClinical Solutions enables users to ingest, integrate, map and standardize data from any source, without programming. The system supports high quality implementation of the CDISC standards and CDISC standards clinical data management efforts by ensuring that data is not only submission-ready, but can be utilized efficiently for data exploration and analysis based on specific needs. elluminate Standards Management provides the ability to browse and search through the CDISC Standards, including CDASH, SDTM, and ADaM, and enables users to find details on industry standards as well as company-specific data standards, without having to leave the elluminate platform. elluminate users easily support their governance and data standardization activities by browsing, researching and finding details on standards metadata within elluminate. elluminate Mapper provides powerful clinical data integration tools that remove the need for custom and ad-hoc programming, all within a fully compliant and auditable environment. elluminate Mapper addresses the increasing prevalence of external data sources in clinical research and the need for teams to provide self-service access to different data streams across the clinical enterprise by providing integration tools, such as dynamic mapping templates that map different types of data automatically upon receipt. Data analysts can map to company specific standards and/or industry clinical data standards including SDTM, without relying on SAS programmers or third parties, and clinical data can be mapped to repositories and into structures aligned to submission requirements.The drag and drop mapping interface enables non-programmers to see transformations as they happen, providing instant feedback on transformation steps. SDTM validation provides instant feedback about standards compliance. New spec gen capabilities with version controls contained in the system will make the process of mapping to standards even easier. 

16:00 - 16:30

CR Toolkit SAS Macro Library

Steven Light, Navitas Data Sciences

The CR Toolkit is a SAS macro library used by SAS programmers to generate tables, listings, and figures using CDISC SDTM and/or ADaM source data. The CR Toolkit provides a comprehensive library of SAS macros that automates clinical reporting. It includes a Comprehensive User Manual and Sample Reports with example TLGs and code snippets to enhance and expedite reporting. Macro parameter metadata is stored separately from macro code and is fully user-configurable. Additionally, metadata to manage titles, footnotes, and output characteristics is centrally stored and provides a single point of control. The CR Toolkit supports the production of output using any SAS ODS-supported file format including RTF, PDF, and HTML. The product is fully validated and documented with complete documentation provided to licensees.

The CR Toolkit supports efficient reporting of CDISC SDTM and ADaM data by reducing the volume of SAS code required to generate reports. Derivation of analysis results is optimized through the use of validated macro code and minimizing coding required in single TLG programs. Macro parameters provide extensive flexibility and maximize the use of the controlled configuration of parameter metadata allows containment of TLG layout specifics in a single location, thus enforcing consistency and reproducibility of reports.

16:30 - 17:00

National Cancer Institute Enterprise Vocabulary Services (EVS) REST API

Brian Carlsen, National Cancer Institute EVS

The National Cancer Institute's Enterprise Vocabulary Services (EVS) REST API is a high performance, modern technology solution for the distribution of standard healthcare terminologies to enable real-time semantic integration between systems that want to share more than simple structural information. EVS supports the development, publication, and maintenance of CDISC Controlled Terminology through the NCI Thesaurus. The EVS REST API distributes CDISC controlled terminologies to support key use cases such as data collection, data analysis, and tabulation of study data.

For the most part, these define syntactic exchange of information - including information about data types, required fields, cardinality constraints, and other technical aspects of data exchange. Sharing of semantic information relies on the binding of data models to controlled terminologies which define the human understood meaning of the values associated with underlying data elements. Currently, CDISC users access CDISC Terminology files from the NCI’s cancer.gov website in 6 file formats; Excel, txt, OWL/RDF, html, pdf, and XML. The EVS REST API enables high performance and real time ability to consume CDISC Controlled Terminology from the NCI Thesaurus into enterprise systems without the need for secondary publication and distribution processes.

As part of the presentation, we will demonstrate capabilities of the product by showing how to use a simple script to extract the entire CDISC ADaM Terminology through a series of API calls.