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Clinical Trials/Studies
eSource Implementation in Clinical Research: A Data Management Perspective
In June 2014, the Society for Clinical Data Management (SCDM)
hails ‘fit for purpose’ eSource the new “gold standard” for clinical trial source data capture.
Final GFI: Electronic Source Data In Clinical Investigations
In January 2014, the FDA
says it “clearly promotes” capturing source data electronically – and is a proponent of eSource.
Guidance for Industry Electronic Source Data in Clinical Investigations
In September 2013, the FDA
promoted the use of eSource Data Capture for clinical studies.
Guidance for Industry Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
In December, 2009, the FDA
discouraged field-based PRO data collection using paper because of the inability to know when the data are entered.
PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force
In 2014, The ISPOR Task Force
stated that “although Web-based instruments appear to be device independent, there are still constraints contingent upon the type of device used to access the Web interface.
Power Source
In August, 2014, International Clinical Trials (ICT),
author Ann Neuer states “eSource streamlines clinical research by resolving one of the key challenges to EDC – the need to transcribe source documents into case report forms (CRFs).”
Medical
Establishing Patient-Centered Physician and Nurse Bedside Rounding
In 2009, Cleveland Clinic
launches a pilot rounding project to improve patient care and physician/nurse communication.
Hourly Rounding: Obtaining Results
The Health Foundation – Evidence-Based Practice
The implications of these findings for nurses would certainly be a more organized workflow, less burnout and fatigue and greater job satisfaction as well as improved patient care and comfort.