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Each CDRL data item should be linked directly to statement of work (SOW) tasks and managed by the program office data manager. Data requirements can also be identified in the contract via special contract clauses (e.g., DFARS), which define special data provisions such as rights in data, warranty, etc. SOW guidance of MIL-HDBK-245D describes ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The statement of work should be directly linked to deliverables shown in the CDRL form. This is done by having each CDRL entry include reference to the SOW paragraph(s) that produces or uses the item, and the SOW text should be clear where it is discussing a deliverable by using the title or parenthesizing the item number (for example, "[A-001]").
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 ...
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.
A United States data item description (DID) is a completed document defining the data deliverables required of a United States Department of Defense contractor. [1] A DID specifically defines the data content, format, and intended use of the data with a primary objective of achieving standardization objectives by the U.S. Department of Defense .
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Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing ...