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The PICO process (or framework) is a mnemonic used in evidence-based practice (and specifically evidence-based medicine) to frame and answer a clinical or health care related question, [1] though it is also argued that PICO "can be used universally for every scientific endeavour in any discipline with all study designs". [2]
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange. In November 2000, HL7 published Release 1.0.
A clinical formulation, also known as case formulation and problem formulation, is a theoretically-based explanation or conceptualisation of the information obtained from a clinical assessment. It offers a hypothesis about the cause and nature of the presenting problems and is considered an adjunct or alternative approach to the more ...
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 ...
A data clarification form (DCF) [1] or data query form is a questionnaire specifically used in clinical research.The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification.
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]
Case series are especially vulnerable to selection bias; for example, studies that report on a series of patients with a certain illness and/or a suspected linked exposure draw their patients from a particular population (such as a hospital or clinic) which may not appropriately represent the wider population.