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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.
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.
In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]
generally contain an application form, an index, a summary, five or six technical sections, case report tabulations of patient data, case report forms, drug samples, and labeling, including, if applicable, any Medication Guide required under part 208 of this chapter. Other
A medical record includes a variety of types of "notes" entered over time by healthcare professionals, recording observations and administration of drugs and therapies, orders for the administration of drugs and therapies, test results, X-rays, reports, etc. The maintenance of complete and accurate medical records is a requirement of health ...
It was argued that PICO may be useful for every scientific endeavor even beyond clinical settings. [2] This proposal is based on a more abstract view of the PICO mnemonic, equating them with four components that is inherent to every single research, namely (1) research object; (2) application of a theory or method; (3) alternative theories or methods (or the null hypothesis); and (4) the ...
Different file systems have different limits on the depth of the filename path, creating potential problems and limitations based on the file system hierarchy in use. [10] Thirdly, with respect to the use of the TMF Reference Model as a database schema, the TMF RM v3.0 spreadsheet cannot be used without manual modification as a classification ...
The high-affinity choline transporter (ChT) also known as solute carrier family 5 member 7 is a protein in humans that is encoded by the SLC5A7 gene. [5] It is a cell membrane transporter and carries choline into acetylcholine -synthesizing neurons .