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.