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CDISC/CDASH Standards at your Fingertips

A standard database structure using CDISC (Clinical Data Interchange Standards Consortium) and CDASH (Clinical Data Acquisition Standards Harmonization) standards can facilitate the collection, exchange, reporting, and submission of clinical data to the FDA and EMEA. CDISC and CDASH standards provide reusability and scalability to EDC (electronic data capture) trials.

There are some defiance in implementing CDISC in EDC CDMS:

  1. Key personnel in companies must be committed to implementing the CDISC/CDASH standards.

  2. There is an initial cost for deployment of new technology: SDTM Data Translation Software, Data Storage and Hosting, Data Distribution and Reporting Software.

  3. It can be difficult to understand and interpret complex SDTM Metadata concepts and the different implementation guides.

  4. Deciding at what point in a study to apply the standards can be challenging: in the study design process, during data collection within the CDMS [CDASH via EDC tools], in SAS prior to report generation [ADaM], or after study completion prior to submission [SDTM].

  5. Data management staff [CDM, clinical programmers], biostatisticians, and clinical monitors may find it difficult to converge on a new standard when designing standard libraries and processes.

  6. Implementing new standards involves reorganizing the operations of (an organization) so as to improve efficiency [processes and SOPs].

  7. Members of Data Management team must be retrained on the use of new software and CDISC/CDASH standards.

  8. There are technical obstacles related to implementation in several EDC systems, including 8 character limitations [SAS] on numerous variables, determining when to use supplemental qualifiers versus creating new domains, and creating vertical data structure.

RAeClinica, an EU-based/Latin American company that can help to manage the transition of your clinical trial to CDISC compliant data standards. We are well informed of the new standards and changes to be released and we can help demystify the guidelines, standards, and processes for your company. Using the powerful engine such as Medidata, Oracle InForm, Oracle Clinical, CMED or OpenClinica, RAeClinical has developed a CDISC compliant standard study design that takes advantage of the benefits of CDISC standardization: decreased study start-up and design time, increased data quality, decreased data redundancy, improved data integration, enhanced scalability and re-usability of global library infrastructures in our Clinical Data Repository, facilitation of data interchange and the ability to exchange and use information with external vendors, decreased time to FDA submission and review of regulatory submissions.

RAeClinica, a consultancy and technology company, offers data management services as well as customized software solutions. This expertise paired with an acute understanding of the CDISC/CDASH initiatives makes RAeClinical an ideal partner for your data management needs.

For more information on the benefits of CDISC and CDASH and what we can provide for your clinical trial, please visit us at raeclinical.wordpress.com or contact us.

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