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The Clinical Data Acquisition Standards Harmonization (CDASH) was designed to standardize data, with recommended data collection fields, implementation guidelines, best practice recommendations and regulatory references. CDASH’s consistent approach to collect trial data providing traceability into the Study Data Tabulation Model (SDTM), enabling greater transparency for health authorities who review the data within a regulatory submission. In addition, with an increasing awareness that proprietary standards prevent data effective information exchange between clinicians and researchers, CDASH is designed to support the integration of research into the clinical workflow.

The objectives and the potential value of CDASH is clear, but the implementation of the data collection standards can be a difficult endeavor. As clinical trial teams try to keep up with complex trial designs and new technologies, monitoring evolving standards adds more work to already overburdened teams. Monitoring the evolution of the standard is a great starting point. However, formally implementing it can be time consuming and resource intensive.

In addition to understanding the collection standard, teams must determine when and where to start using the standard. Each trial must be evaluated for implementation. Any potential impact of the standard on trial timelines must be assessed. These activities help to prioritize trials and create a foundation for an implementation schedule.

Finally, as with any new process or approach, change can be difficult, particularly for established teams. Even simple things like adopting the CDASH CRF name and field naming terminology change can present challenges. For example, many clients have established form and field names (e.g. Study Exit – Study Exit Date), whereas CDASH calls for “Disposition – Study Completion/Discontinuation Date.”

CDASH Compliant CRFs in iMednet

The Mednet team analyzed the CDASH recommendations and developed a set of conformance rules to help shape CDASH compliance features. We appreciate the value of collection standards within the clinical data lifecycle and have started to implement CDASH standards within our product strategy and designing its CRF templates to conform to CDASH standards. In addition, Mednet’s experienced team understands the fundamentals of the globally used standards and can work with research teams to guide them in the right direction as it relates to therapeutic specific standards.

As a result, iMednet customers can take advantage of CDASH compliant CRF templates and counsel during a study build, enabling them to get studies up and running quickly, while also taking the guesswork out of conforming to standards. Currently, the iMednet library includes a set of CDASH compliant CRF templates, based on common domains. The standards are preconfigured within the form templates to ensure data is collected in a consistent fashion once they are used within a study.

The standardized forms and domains also ensure data collection formats and structures provide traceability of submission data into the SDTM. The use of CDASH data collection fields facilitates mapping and compliance with SDTM or the “submission standard.”

Once the CDASH standards are defined and data points collected, clients can export any/all data collection points at any given time using iMednet’s Datasets on Demand application and export functionality. The exported datasets can then be formatted, organized, mapped, analyzed, and warehoused according to client’s requirements.

CDASH compliant CRF templates in iMednet increase compliance while reducing the time and resources required to develop the case report forms during study build. Implementing CDASH compliant CRFs reduces variability across CRFs and thus, also reduces site training time.

In addition to operational efficiencies, the iMednet eCRFs offer end-to-end traceability of the variable name from iMednet to the SDTM datasets, offering the transparency that drove development of the CDASH standard in the first place.

Mednet’s comprehensive, EDC-centric eClinical platform and comprehensive solution are uniquely designed to help organizations to address the evolving demands and requirements of clinical research, while also enabling them to get studies up and running quickly. To learn more about iMednet or our approach to conforming to CDASH standards, contact us.