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What is CDISC?
The Clinical Data Interchange Standards Consortium (CDISC) is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in our industry.
What are the benefits of implementing CDISC data standards?
These standards provide maximum sharing of information and minimum duplication of efforts. They facilitate sharing, exchange and analysis of data by creating a common platform for organization, structure and presentation.
How can you get familiar with CDISC activities and standards?
Visit the CDISC website. In addition, you can register for training on particular CDISC topics. Organizations can also join CDISC at various membership levels. Members are encouraged to become active participants in CDISC working groups and other activities.
What is ODM?
The Operational Data Model (ODM) provides a format for representing the study metadata, study data and administrative data associated with a clinical trial. It represents only the data that would be transferred among different software systems during a trial, or archived after a trial. The ODM is an xml based standard that facilitates vendor to vendor data exchange. It also facilitates the archival and exchange of clinical data between sponsors, CROs and data management companies.
What is ADaM?
ADaM (Analysis Dataset Model) offers metadata models and examples for analysis datasets used to generate the statistical results for regulatory submissions. The concept is built on models developed for safety domains, adding attributes and examples relevant to statistical analysis.
What is SEND?
SEND is the Standard for Exchange of Nonclinical Data. This model has been prepared to guide the organization, structure, and format for non-clinical data submitted to the U.S. FDA. The focus is on data collected from animal toxicology studies.
Do you still need to submit an annotated CRF for US Submissions in CDISC format?
Yes. The annotated CRF is still required.
How do you handle variables that cannot be mapped to CDISC Domains?
This issue is resolved in the version 3.1 specification through the use of special qualifiers, which account for all other variables that don’t map to the current structure of domains.
Do you need to include code variables in CDISC datasets?
No. There are no coded fields in CDISC compliant datasets.
How can you seek assistance with CDISC related implementation questions?
You may opt to attend CDISC sponsored training or visit the CDISC website to access Registered CDISC Solution Providers (RCSP). These providers are qualified consultants, system integrators, and subject matter experts believed by CDISC to have sufficient knowledge and experience implementing the various CDISC standards. Octagon is a registered solution provider.
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