Data standards for clinical research data collection forms: current status and challenges.
Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption [...]
Author(s): Richesson, Rachel L, Nadkarni, Prakash
DOI: 10.1136/amiajnl-2011-000107