Commonly used medical data-collection approaches in clinical research

In clinical research, data collection entails acquiring important variables to research hypotheses. According to the International Organization for Standardization/International Electro-technical Commission (ISO), a data element is defined as a component of data for which the definition, identification, representation, and permissible values are specified through a set of attributes, according to the International Organization for Standardization/International Electro-technical Commission (ISO/IEC) 11179 technical standard. Internal names, data types, user-facing captions, extensive descriptions, and basic validation information like range checks and set membership are examples of such features. Reusing data elements and CRFs can cut research implementation time and make data gathered from numerous sources easier to share and analyze. We describe essential CRFs standards and their limitations in this study and highlight significant unsolved informatics-standardization difficulties in improving research procedures and facilitating data interchange in research and healthcare.

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            In clinical research investigations, case report forms (CRFs) collect organized data. The structural elements of forms and data items, content standards, and specifications for employing terminologies are all covered by existing CRF-related standards. This study examines current standards and identifies their shortcomings. Because clinical research is so protocol-specific, developing forms is easier to standardize than the content of CRFs. Standards adoption in clinical research applications will be facilitated by tools that allow for retrieving and reusing existing items. Formal linkages between things and terminological standards will be required for such tools. Clinical research informatics can assist in defining tool requirements in terms of research workflow support, reconciling the viewpoints of many clinical research stakeholders, and coordinating standardization initiatives toward interoperability across healthcare and research data collecting.

Reference:

  1. Rachel L Richesson and Prakash Nadkarni; Data standards for clinical research data collection forms: current status and challenges, J Am Med Inform Assoc. 2011 May-Jun; 18(3): 341–346.