If you need CDISC services, contact us at info@sofpromed.com
CDISC services are related to CDISC standards, one of the most important data management standards in the clinical research industry. CDISC standards are recognized around the world and required by some regulatory agencies for clinical trial data submissions, including the FDA of the United States.
Read on to learn more about CDISC standards and CDISC services.
- $What Is CDISC?
- $What Are CDISC Standards?
- $Are CDISC Standards Required by Regulators?
- $Which CDISC Standards Are Required by the FDA?
- $What is CDASH and Why Is It Important?
- $What Are the Benefits of Using CDISC Standards?
- $When Are the CDISC Standards Implemented in a Clinical Trial?
- $What CDISC Services Are Available to Implement CDISC Standards in Clinical Trials?
What Is CDISC?
CDISC stands for the Clinical Data Interchange Standards Consortium. This global non-profit organization was founded in 2000 with the mission of developing industry-level electronic data standards for use in clinical trials at all stages.
Composed of representatives from all stakeholder groups in clinical trials, it set out to define and manage global, platform-independent industry standards to support the electronic acquisition, exchange, archiving, and submission of clinical trial data. Over the last twenty years, it has developed and refined standards for data collection and use that can be applied from beginning to end of a clinical trial for a complete electronic data workflow.
What Are CDISC Standards?
In addition, it includes defined and controlled terminology and additional therapeutic area-specific extensions for applying the standards in various specialties. CDISC standards can be used in medical device trials and pharmacogenomic trials as well.
CDISC divides the standards into the following principal categories:
- Foundational Standards, a complete suite of standards that includes models, domains, and specifications for supporting clinical and non-clinical research processes from end to end. Regarding clinical trials, the main ones are Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM).
- Data Exchange Standards, a set of standards to facilitate sharing the data created with the foundational standards across information systems. The most important standard for clinical trials is Define.xml
- CDISC Therapeutic Areas, which extend the Foundation Standards to represent data more pertinently according to specific disease areas.
- Controlled Terminology, a set of expressions for use in CDISC-defined data sets. It can also be used in other clinical trial documentation.
Are CDISC Standards Required by Regulators?
CDISC standards are recognized globally but only two regulatory bodies currently require that trial data be submitted in CDISC standards.
The United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) now require that data be submitted using certain CDISC standards. CDISC and these agencies collaborate closely.
Even if CDISC is not required, the standards are widely recognized. They also ensure interoperability with other standards including DICOM, HL7, IHE, ISO, LOINC, MedDRA, and SNOMED.
Which CDISC Standards Are Required by the FDA?
The FDA requires that clinical trial data be submitted using CDISC Controlled Terminology, SDTM, ADaM, and Define.xml.
SDTM is the standard for organizing and formatting data. It also supports data aggregation and warehousing, fosters data mining and reuse, facilitates sharing, helps with data review activities, and speeds up the regulatory review and approval process.
ADaM defines dataset and metadata standards for more efficient generation, replication, and review of clinical trial statistical analyses. It also ensures traceability within analysis data sets and the SDTM.
Define.xml works with SDTM and ADaM to transmit the metadata and thus inform regulators which datasets, variables, controlled terms, and other specified metadata were used in the tabular datasets structure.
Controlled Terminology provides a glossary of the set language to be used within the data, making the data cleaner and easier for reviewers to understand.
What is CDASH and Why Is It Important?
Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review [1].
What Are the Benefits of Using CDISC Standards?
Implementing CDISC Standards:
- Fosters efficiency, reducing costs.
- Improves data quality.
- Ensures complete traceability.
- Makes data sharing easier.
- Increases predictability.
- Streamlines clinical trial data collection and processing.
When Are the CDISC Standards Implemented in a Clinical Trial?
CDISC standards can be implemented at any point of a clinical trial. They can be established from the very first stages of planning and data collection, or data may be converted to CDISC format when preparing for submission.
Early implementation of CDISC standards has been shown to lead to higher quality data and avoids the delays, problems, and expense which converting data can incur. It also facilitates collaboration with other entities, especially important for small to mid-sized biotech firms that may be hoping to collaborate or have their data purchased by a larger company. The same principle applies to working with various vendors and clinical sites during a trial. Early standardization of language and data format leads to cleaner data and only makes the aggregation, analysis, and review processes easier.
Using industry-wide standards for data also creates a “standards” mindset that foments a culture of quality data while facilitating communication between the various stakeholders of a pharmaceutical trial.
Nevertheless, some companies are hesitant to invest in committing to CDISC compliant data packages before knowing if the results of the trial will lead to a final submission to regulators. In this case, or for any other reason that data is not already in a CDISC standards-compliant format, the data can be converted using CDISC standards.
What CDISC Services Are Available to Implement CDISC Standards in Clinical Trials?
Both CROs and software companies specialized in clinical trials offer services that help sponsors use and implement CDISC standards at any point of a clinical trial.
Data management planning
It is important to make a clear and precise plan for data management beyond the data-related documentation and planning required by regulators. The planning stage of a trial is the moment to assess and decide when and how to implement CDISC standards. Any company that provides CDISC services can give sponsors a clear assessment of the advantages, necessity, and expense of implementing CDISC at various points of their trial.
Use of CDISC in a Statistical Analysis Plan (SAP)
The SAP makes reference to the required documentation that describes in detail how data has been analyzed and presented. If CDISC standards are being used in the trial, the terminology, and other aspects of CDISC can be delineated.
CDISC-compliant CRF
Using CDISC standards, in particular terminology, for electronic Case Report Forms (CRFs) helps ensure quality data and ease of analysis and review. At the CRF level, CDASH is used to ensure standardized data collection.
Statistical programming using CDISC standards
All programming tasks —generation of tables, figures, and listings, including reports— can be done in compliance with CDISC standards.
CDISC-compliant Reviewer’s Guide
When using CDISC standards, it is necessary to write the Reviewer’s Guide accordingly.
Full, submission-ready CDISC compliant data package
All data should be collected, organized, analyzed, and prepared for submission using CDISC standards. This provides a seamless, data management solution, and ensures maximum data quality and efficiency.
CDISC compliant SAS programming
SAS and CDISC work closely together. SAS programmers can implement CDISC standards into their coding.
If you need CDISC services, contact us at info@sofpromed.com
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