The Healthcare industry is offering incredible services to healthcare professionals and patients. Over the years, digitization has made a strong impact on the healthcare industry
and is benefitting the healthcare professionals in several ways. The experts are using several standard terms in the healthcare services to describe and to code the data elements.
One of the common terms used is the Clinical Data Interchange Standards Consortium or popularly known as (CDISC) is a standard developing organization that deals with medical research data associated with healthcare services. It allows the information system interoperability to enhance medical research and other areas of healthcare.
CDISC standards are the basis of complete standards that support clinical and non-clinical research processes from scratch. It includes specifications and domains for data representation.
Let us understand what CDISC is in-depth and its impact on the healthcare industry.
What Do You Understand by CDISC (Clinical Data Interchange Standards Consortium)?
The US Food and Drug Administration has issued guidance that sponsors and submit clinical trial data using the Study Data Tabulation Model format developed by CDISC. It is a non-profit organization that supports different global standards to enhance the quality and interoperability of research and healthcare. It is majorly used for planning, analysis, and submissions to Japanese Pharmaceuticals and other agencies internationally.
It has partnered with NCI EVS to develop and support terminologies foundational standards, including Define - XML, SEND, and Therapeutic Area standards. EVS distributes CDISC controlled terminology as a part of NCI Thesaurus.
Therapeutic Area extends the Foundational Standard to represent data that limits to specific areas. It includes guidance on implementing CDISC standards. CDISC standards are aligned with the needs of trial data exchange and are related to clinical research workflow.
CDISC has mapped its data model onto the HL7
reference information model. It also stays neutral and provides mappings to other standards such as CEN. The mission statement of CDISC reads,
“The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.”
CDISC standards are platform-independent are ADaM, SDTM, SEND.
Define-XML supports the exchange of metadata for research applications in a machine-readable format. The key components to support submissions are valued list definitions, dataset variables, and comments definitions. It can be used to describe proprietary and non-CDISC dataset structures.
What is Controlled Terminology?
It is a set of valid values that are used with data items within CDISC-defined databases. It offers the value required for submission to FDA and PMDA in CDISC compliant data sets. It doesn’t tell you what to collect instead tells you how to submit the collected data in the electronic dataset.
What Does CDISC Do?
It supports the exchange, acquisition, archive of data, and biopharmaceutical product development. It releases requirements and guidelines that influence the PMDA and FDA on standards for both non-clinical data and clinical data. The CDISC standards support medical research for different protocols through the reporting of results.
Why is CDISC Important?
If CDISC is properly implemented, then it decreases timelines and costs during drug development and leads to marketing authorization. Furthermore, standardization enhances and improves the science of drug development.
Different Terms Used in CDISC
1. Operational Data Model (ODM)
The Operational Data Model (ODM) facilitates the regulatory-compliant acquisition and interchanging of data for clinical research studies. The model includes the data associated with administrative data, metadata, and audit information. This Data Model was introduced in 1999, and the latest version1.3.2 was released in 2012.
Its extensions have been developed to create additional CDISC standards. Operational Data Model (ODM) is an XML
based standard and an XML schema that offers several constructs for electronic Case Report Forms.
It is often combined with the Data Model to more fully model trial arms. It is used in sending forms data from a trial system to an EHR system. The highlights of ODM utilizes XML technology. The other information is independent of the database and is machine and human-readable.
Clinical Trial Representation allows the representing of basic characteristics such as study sponsor and the size of the trial. This standard was first launched in 2006 with the 2nd version released in 2008.
3. CDISC-Registered Solutions Providers
It maintains a list of solutions, subject matter experts, and consultants to have knowledge and experience for implementing the different CDISC standards.
It is a unifying model of the domain of research studies and defines basic elements such as study intervention and subject. It is the HL7 ISO standard for biomedical research concepts and supports semantic interoperability. It can be used for different purposes as data integration and an exchange format.
When BRIDG is used as a model to create or add content to a standard, it ensures that the relationships between biomedical research are represented using a standard that should be consistently modeled.
CDISC SHARE is a data repository that supports the governance and consumption of CDISC Standards in machine-readable and human-readable formats. It helps users to understand and to use rich relationships among data elements, attributes, and other controlled terminologies.
It provides a collaborative development environment that would improve quality and consistency across CDISC standards.
6. PMDA Requirements
The Japanese Pharmaceuticals and Medical Devices Agency switched to CDISC standards in 2016 and required that the submissions should be filed on or after October 2016 to use CDISC compliant formats.
7. FDA Requirements
FDA requires all submission data for studies on or after December 2016 to be CDISC compliant. The submissions include ANDAs, INDs, and BLAs.
What are Adam Datasets and SDTM?
The SDTM datasets provide and organize clinical trial data for the database lock. It provides a connection between the SDTM data sets and statistical analyses.
Benefits Offered When CDISC Standards are Used in Healthcare Industry
It improves data quality, enhances innovation, and reduces costs. Furthermore, it facilitates data sharing and increased predictability. CDISC offers streamlined processes and enhanced innovation.
It provides defined research concepts across the entire study research team. CDISC shares de-identified data with different researchers working on the problem. It supports the reusability of eCRFs, edits check to program, and analysis programming.
CDISC Goals 2012-2015
1. To develop a CDISC share that allows the precise and standardized element definitions that can be reused and across studies to improve research and its link with healthcare.
2. To achieve progress in enabling interoperability between clinical research and clinical care. And to accelerate the cycle through which healthcare research and research informs clinical decisions.
3. To expedite the development and to focus on the therapeutic-area or different standards, while continuing to support existing foundational standards.
4. To vendor-neutral and independent status to make productive collaborations by providing value to communities.
The Clinical Data Interchange Standards Consortium defines standards to deal with research linked with life sciences. It was founded in 1997 but incorporated in 2000.
The standard is used by over 90 countries and has over 11000 participant databases. It has over 20 user networks around the world. It supports medical research from protocol and reporting of results and has decreased the resource-needs by 70-80%.