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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.
A background check is a process used by an organisation or person to verify that an individual is who they claim to be, and check their past record to confirm education, employment history, and other activities, and for a criminal record. The frequency, purpose, and legitimacy of background checks vary among countries, industries, and individuals.
A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with clinical research coordinators. [4] Clinical research associates also "ensure the protection of the rights, safety and well being of human study subjects."
Provide clinical summaries to patients for each office visit. Capability to exchange key clinical information electronically among providers and patient authorized entities. Protect electronic health information (privacy & security) Menu Requirements: Implement drug-formulary checks.
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.
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The FBI Name Check is a background check procedure performed by the Federal Bureau of Investigation for federal agencies, components within the legislative, judicial, and executive branches of the federal government; foreign police and intelligence agencies; and state and local law enforcement agencies within the criminal justice system.
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