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Patient registration is used to correlate the reference position of a virtual 3D dataset gathered by computer medical imaging with the reference position of the patient. This procedure is crucial in computer assisted surgery, in order to insure the reproducitibility of the preoperative registration and the clinical situation during surgery. The ...
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems.
Sample view of an electronic health record. An electronic health record (EHR) also known as an electronic medical record (EMR) or personal health record (PHR) is the systematized collection of patient and population electronically stored health information in a digital format. [1] These records can be shared across different health care settings.
The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
PRO data may be collected via self-administered questionnaires, which the patient completes themselves, or through patient interviews. The latter will only qualify as a PRO, however, if the interviewer is gaining the patient's views and not using the responses to make a professional assessment or judgment of the impact of a treatment on the ...
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
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