Clinical Internship with the Anterior Segment Clinical Division at Alcon Laboratories, Inc.: Electronic Data Capture (EDC) Approach vs. Paper-Based Approach to Data Management

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dc.contributor.advisorRouel Roque
dc.contributor.committeeMemberJudy Vittitoe
dc.contributor.committeeMemberTerri Pasquine
dc.creatorCrout, Danyel C.
dc.date.accessioned2019-08-22T21:26:02Z
dc.date.available2019-08-22T21:26:02Z
dc.date.issued2003-11-01
dc.date.submitted2013-12-13T10:06:04-08:00
dc.description.abstractAlthough electronic data capture (EDC) has been available for 20 years or more, companies have remained hesitant about its applicability to enhance clinical trial conduct. Before any company adopts a process that is new to their organization, the procedures and regulations must be practiced and perfected. Pilot trials are developed to gain more knowledge and ease about the proposed process change. Already this year, the clinical data management (CDM) department reported that they have processed over a quarter-million paper case report forms (pCRFs). CDM is an internal component in maintaining clinical trial databases to be used during FDA submissions for approval to market a test article, therefore, data management processes are constantly improved while options are cyclically evaluated. EDC has been recently recognized within Alcon as a possible alternative to improving the efficiency of data collection while simultaneously decreasing data processing time. As a result, this prospective option was compared against the two processes of data management that Alcon currently uses with paper CRFs.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/29329
dc.language.isoen
dc.provenance.legacyDownloads0
dc.subjectHealth Services Administration
dc.subjectHealth Services Research
dc.subjectMedicine and Health Sciences
dc.subjectOther Public Health
dc.subjectPublic Health
dc.subjectElectronic data capture
dc.subjectAlcon
dc.subjectclinical trial
dc.subjectenhance
dc.subjectclinical data management
dc.subjectdata collection
dc.subjectpaper case report forms
dc.titleClinical Internship with the Anterior Segment Clinical Division at Alcon Laboratories, Inc.: Electronic Data Capture (EDC) Approach vs. Paper-Based Approach to Data Management
dc.typeThesis
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

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