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A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
Continuity of Care Document - The Continuity of Care Document (CCD) represents a core data set of the most relevant administrative, demographic, and clinical information facts about a patient's healthcare, covering one or more healthcare encounters. The primary use case for the CCD is to provide a snapshot in time containing the germane ...
The clinical audit process seeks to identify areas for service improvement, develop & carry out action plans to rectify or improve service provision and then to re-audit to ensure that these changes have an effect. Clinical audit can be described as a cycle or a spiral, see figure.
In the second stage of meaningful use, the CCD, but not the CCR, was included as part of the standard for clinical document exchange. [9] The selected standard, known as the Consolidated Clinical Document Architecture (C-CDA) was developed by Health Level 7 and includes nine document types, one of which is an updated version of the CCD. [2]
An XML element in a CDA supports unstructured text, as well as links to composite documents encoded in pdf, docx, or rtf, as well as image formats like jpg and png. [ 3 ] It was developed using the HL7 Development Framework (HDF) and it is based on the HL7 Reference Information Model (RIM) and the HL7 Version 3 Data Types.
A history (audit trail) must be maintained of changes and deletions to electronic versions [2] [4] [5] Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document.