CDISC
standards now cover the entire biomedical research process, from protocol representation through analysis and reporting. In order to increase the delivery of standards updates and meet the needs of industry and regulatory bodies, CDISC needed a different model to augment its current processes. The CDISC Shared Health and Clinical Research Electronic Library (CDISC SHARE) is envisioned as a global, accessible, electronic library, which through advanced technology, enables precise and standardized data element definitions that can be used within applications and across studies to improve biomedical research and its link with healthcare. This new initiative seeks to develop multi-dimensional, machine-readable clinical study metadata that is based on ISO data standards and the BRIDG model.
The US National Cancer Institute – Enterprise Vocabulary Service (NCI-EVS) has a long tradition of working with partners to create and publish controlled terminology and has collaborated with CDISC since 2004 to develop and publish CDISC controlled terminology for the entire suite of CDISC standards (e.g. the SDTM, CDASH, SEND, etc.). NCI has agreed to include CDISC SHARE system requirements in the development of their enhanced semantic infrastructure.
Frank Rockhold, Chair of the CDISC Board of Directors, stated, “SHARE is a significant shift in the way that CDISC will create its standards and will allow for acceleration in the development of new therapeutic area standards. The first release will contain the existing SDTM and CDASH standards and should be available for use in the second half of 2011 with new content following shortly after.”
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
2 Commerce Drive
Cranbury, NJ 08512