1 |
Marks R, "Validating e-Source Data in Clinical Trials," Controlled Clinical Trials, Vol.25, pp. 437-446, 2004.
DOI
ScienceOn
|
2 |
Welker J, "Implementation of EDC Systems: Barriers and Solution," Contemporary Clinical Trials, Vol.29, pp.329-336, 2007.
|
3 |
Arab L, Hahn H, Henryo J, Chacko E, Winter A and Cambou M, "Using the Web for Recruitment, Screen, Tracking, Data Management, and Quality Control in Dietary Assessment Clinical Validation Trial," Contemporary Clinical Trials, Vol.31, pp.138-146, 2010.
DOI
|
4 |
Lu Z, "Technical Challenges in Designing Post- Marketing eCRFs to Address Clinical Safety and Pharma- covigilance Needs," Contemporary Clinical Trials, Vol.31, pp.108-118, 2010.
DOI
|
5 |
Broeck J, Cunningham S, Eeckels R, Herbst K, "Data Cleaning: Detecting, Diagnosing and Editing Data Abnormality", PLoS Medicine [Online]. Vol.2, No.10. pp.966-970, 2005. Available: www.plosmedicine.org
|
6 |
Knatterud G, Ricjgikdm F, Gerigem S , Barton F, Davusm C, Faiweather W, Honohan W, Mowery R and O'Neill R, "Guidelines for Quality Assurance in Multicenter Trials: A Position Paper," Controlled Clinical Trials, Vol.19, pp.477-493, 1993.
|
7 |
Moher D, Jada A, Nichol G, Penman M, Tugwell P and Walsh S, "Assessing the Quality of Randomized Controlled Trials: An Annotated Bibliography of Scales and Checklists," Controlled Clinical Trials, Vol.16, pp.62-73, 1995.
DOI
|
8 |
Nahm M, PieperC, CunninghamM. "Quantifying Data Quality for Clinical Trials Using Electronic Data:, PLoSMedicine[Online].3(8). pp.1-8. www. plosmedicine.org, 2008
|
9 |
Lee H and Choi I, "Effect Analysis of Electronic Clinical Trial Systems Using Measurement Indicator of Efficiency," Journal of Korea Contents Association, Vol.11, No.1, 2011.
|
10 |
Pavlovic I, Kern T and Miklavcic D, "Comparison of Paper-based and eData Collection Process in Clinical Trials: Costs Simulation Study," Contemporary Clinical Trials, Vol.30, pp.300-316, 2009.
DOI
|
11 |
Ene-Idordache,B, Carminati S, Antiga L, Rubis,N, Ruggenti P, Remuzzi G and Remuzzi A, "Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with Demand Trial," Journal of America Information Association, Vol.16, pp.404-408, 2009.
DOI
|
12 |
Prodeedings of 14th Annual Workshop in DIA Japan for Clinical Data Management; New Genesis of CDM to Drive Worldwide Clinical Studies. Jan. 2011
|
13 |
Prokscha S, Practical Guide to Clinical Data Management, Taylor and Francis, 2007.
|
14 |
Guide for Industry; Computerized Systems Used in Clinical Investigations (CSUCI), FDA, 2005. April.
|
15 |
Okoli C and Pawlowski S, "The Delphi Method as a Research Tool: Example, Design Considerations and App," Inf& Management, Vol.42, pp.15-42, 2004.2004,
DOI
|
16 |
Guidance for Industry, E6 Good Clinical Practice,
|
17 |
Korean Good Clinical Practice, KFDA, 2009.
|
18 |
Stanley R, Lillis K, Zuspan S, Lichenstein R, Ruddy R, Gerardi M and Dean J, "Development and Implementation of a Performance Measure Tool in an Academic Pediatric Research Network," Contemporary Clinical Trial.,Vol.31, pp.429-437, 2010.
DOI
|
19 |
Schmidt R, "Managing Delphi Surveys Using Non-parametric Statistical Techniques," Decision Sciences, Vol.28, No.3, pp.763-774, 1997.
|
20 |
Edmondson A, Bohmer R and Pisano G, "Disrupted Routines: Team Learning and New Technology Implementation in Hospitals," Administrative Science Quarterly, Vol.46, No.4, pp.685-716. 2001.
DOI
|
21 |
Marray J & Hammon J. "Delphi: A Versatile Methodology for Conducting Qualitative Research," The Review of Higher Education, Vol.18(4), pp.423-436, 1995.
DOI
|