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The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
Another example is the DART system, organized into Description, Assessment, Response, and Treatment. [2] Documentation of care and treatment is an extremely important part of the treatment process. Progress notes are written by both physicians and nurses to document patient care on a regular interval during a patient's hospitalization.
The application software resides on the vendor's system and is accessed by users through a communication protocol. Alternatively, the vendor may provide special purpose client software. Client software may interface with these systems through an application programming interface. ASP characteristics include: ASP hosts the application [2]
Continuous monitoring is the process and technology used to detect compliance and risk issues associated with an organization's financial and operational activities. It actively identifies, quantifies and reports control failures such as duplicate vendor or customer records, duplicate payments, and transactions that fall outside of approved ...
A National Provider Identifier (NPI) is a unique 10-digit identification number issued to health care providers in the United States by the Centers for Medicare and Medicaid Services (CMS). The NPI has replaced the Unique Physician Identification Number (UPIN) as the required identifier for Medicare services, and is used by other payers ...
A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
Database activity monitoring (DAM, a.k.a. Enterprise database auditing and Real-time protection [1]) is a database security technology for monitoring and analyzing database activity. DAM may combine data from network-based monitoring and native audit information to provide a comprehensive picture of database activity.
A service provider (SP) is an organization that provides services, such as consulting, legal, real estate, communications, storage, and processing services, to other organizations. Although a service provider can be a sub-unit of the organization that it serves, it is usually a third-party or outsourced supplier.