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Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
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. The DCF is part of the data ...
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.
The U.S. Food and Drug Administration (FDA) now classifies eggs as a “healthy, nutrient-dense" food, according to a new proposed rule. Registered dietitians react to the change.
With a government shutdown narrowly avoided late Friday into Saturday morning, the House and Senate sent a funding bill to President Joe Biden's desk. An initial bipartisan deal was tanked earlier ...
Data type validation is customarily carried out on one or more simple data fields. The simplest kind of data type validation verifies that the individual characters provided through user input are consistent with the expected characters of one or more known primitive data types as defined in a programming language or data storage and retrieval ...