Dr. Lauren Becnel is VP Strategy and Innovation for Clinical Data Interchange Standards Consortium (CDISC).

Dr. Lauren Becnel

	As a global, non-profit, charitable organization, Clinical Data Interchange Standards Consortium (CDISC) is dedicated to creating mechanisms that allow data to speak the same language in order to foster smarter research that can facilitate the discovery of new treatments, breakthroughs, and cures.

	CDISC’s community of volunteers and staff develop and maintain data standards, which are freely available in PDF format on our 

. Global regulators understand the value of implementing standards, exemplified by the FDA and Japan’s PMDA requiring the use of CDISC Standards for new drug submissions. Further, the value of standards goes far beyond complying with regulation. For example, application of CDISC standards has led to changes on how low-weight children suffering from malaria in sub-Saharan Africa are treated, which has caused the reduction of mortality in these vulnerable patients. It has also supported the discovery of clinical research biomarkers for polycystic kidney disease and Parkinson’s disease-the evidence for which had been hidden in non-standardized datasets for years prior to their standardization, aggregation, and analysis. These biomarkers now enable researchers to identify diseases early, when intervention may be possible.

	Nonetheless, standards in PDF format are easy for humans to read and interpret, but machines cannot easily read them, which means that those who implement the standards must hand extract standards from these documents-an error-prone and costly process. To provide machine-readable, curated versions of our standards, and with the support of TransCelerate Biopharma, Inc., CDISC has created the cloud-based Shared Health and Research Electronic library (

) platform to free our standards from PDF documents. SHARE provides multiple versions of each standard in various structured formats (e.g., Excel, JSON, ODM-XML, Define-XML, RDF).

	These machine-readable standards can facilitate process automation and innovation in software where standardized protocol information is pre-populated alongside electronic data capture forms, which can flow into standard reports and analytical datasets in the diverse electronic systems for sponsors, clinical research organizations and sites. Because SHARE represents standards interconnections as part of its model, end users can see which variables are shared between, or among, CDISC standards. SHARE also maintains relationships that express the mappings that link variables across the different phases of the clinical research data lifecycle (e.g. 

). Taken together, these features support beginning-to-end standards implementation.

	SHARE also provides “Diff files” that define what has been added, deleted, or changed in one version of a standard to another, to support impact analyses that determine what changes need to be made, and in which electronic systems, when considering version upgrades. By layering basic web templates over metadata from CDISC’s data collection standard, 

CDASH (Clinical Data Acquisition Standards Harmonization)

, systems can automatically generate electronic case report forms (CRFs) with elements that are common to essentially any clinical study.

	Files exported from SHARE are ideal for data standards experts, data managers, and biostatisticians who want to download CDISC standards in formats such as Excel or XML. These SHARE exports are available on the CDISC website Members Only Area and to individual academic researchers 

	The SHARE API v1.0, released in January, is open to 

 members for an annual license fee. The API is a “RESTful web service” and ideal for those with a technical background who would like to retrieve machine-readable standards to automate access of their electronic systems’ access to the latest CDISC standards. CDISC is committed to continuing to enhance the value of the SHARE API over the next few years; licensed early adopters of the SHARE API will have the unique opportunity to provide prioritized feedback, enhancement requests and statements of value to the SHARE team for an upcoming version 2.0 release. End user documentation is available for 

Articles

CDISC executive talks about the creation of their cloud-based platform to free standards from PDF documents.


Author | Dr. Lauren Becnel