What are Therapeutic Area (TA) Standards?
CDISC and our partners have published multiple TA standards, which can be used in concert with CDISC Foundational Standards and Controlled Terminologies. TA Standards pertain to the general conduct of the lifecyle of any regulated research protocol to standardize how data specific to a given disease area or process, are collected across different protocols. Because standardized TA data can be aggregated and integrated as part of sophisticated analyses, their use helps the U.S. FDA, Japan PMDA and other regulatory bodies assess regulated trial data.
How does SHARE support TAs?
SHARE expedites the development of TA standards by re-using existing variables and rules. For example, many oncology TA concepts are the same across many different solid tumors and blood cancers. Therefore, oncology concepts developed for breast cancer can be rapidly identified in SHARE and pulled out for TA development teams to re-use in other cancers, such as colorectal or lung cancer. Tools also exist in the SHARE ecosystem to automatically generate TA specifications and sections of their user guides.
Currently, SHARE includes normative content from TA standards. These metadata are available for download via SHARE in the Members Only Area of the CDISC website to members. The SHARE Team is working with CDISC TA Team Leaders to expand electronic content creation to develop more TA content, including informative examples that provide details on how a concept should be used in a specific case available in SHARE.