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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.
In such CDMSs, the investigators directly upload the data on CDMS, and the data can then be viewed by the data validation staff. Once the data are uploaded by site, the data validation team can send the electronic alerts to sites if there are any problems. Such systems eliminate paper usage in clinical trial validation of 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.
The Fast Healthcare Interoperability Resources (FHIR, / f aɪər /, like fire) standard is a set of rules and specifications for the secure exchange of electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide range of settings and with different health care information systems.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
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 ...
TikTok will be banned in the United States on Jan. 19, 2025, after a federal appeals court rejected its bid to overturn the ban that President Biden signed in April. The law states that if TikTok ...
[3] [4] OMOP developed a Common Data Model (CDM), standardizing the way observational data is represented. [3] After OMOP ended, this standard started being maintained and updated by OHDSI. [1] As of February 2024, the most recent CDM is at version 6.0, while version 5.4 is the stable version used by most tools in the OMOP ecosystem. [5]