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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.
EHR systems are designed to store data accurately and to capture the state of a patient across time. It eliminates the need to track down a patient's previous paper medical records and assists in ensuring data is up-to-date, [5] accurate and legible. It also allows open communication between the patient and the provider, while providing ...
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
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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