Clinical Trials/Studies

eSource Implementation in Clinical Research: A Data Management Perspective
SCDM 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
FDA 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
FDA 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
FDA 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
ISPOR 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
Samedan 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).”


Establishing Patient-Centered Physician and Nurse Bedside Rounding
Cleveland Clinic In 2009, Cleveland Clinic launches a pilot rounding project to improve patient care and physician/nurse communication.
Hourly Rounding: Obtaining Results
Health Foundation 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.
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