EClinical References


ACDM/PSI Working Party (1998). Computer Systems Validation In Clinical Research: A Practical Guide.

Carroll, J. (1996). The changing shape of technology in clinical trials. Presented at the Barnett International Electronic Data Capture conference, London, England.

Chadwick, B. (19?). To ‘e’ Or Not. Pharmaceutical Visions. 12-21.

Chew, N., Morgan, J. & Wartowski, C. (1998). Taming the paper tiger at FDA. Applied Clinical Trials. February 1998.

Chowienczyk, P. J., Lawson, C. P., Morris, J. et al (1992). Electronic diary to record physiological measurement. Lancet. 339; 251.

Coats, Connolley et al (1997). Adventures in computerised remote data entry. The Monitor. Spring 1997.

Diener-West, M., Connor, P. B., Newhouse, M. M. et al (1998). Feasibility of keying data from screen-displayed facsimile images in an ongoing trial: The collaborative ocular melanoma studies. Control Clinical Trials. 19; 39-40.

Electronic records; electronic signatures (1997). Federal Register. 62; 13429-13466.

Gibson, H. et al (1994). Is double data entry necessary? The CHART trials. Controlled Clinical Trials. 15; 482-488.

Henderson, S. (s1997). Rethinking clinical data management. Presented at the DIA 7th Annual European Workshop on Clinical Data Management, Paris, France.

Higgins, S. B., Jiang, B. & Plummer, W. D. Jnr. et al (1995). Pivotal/Remote: A distributed database for remote data entry in multi-centre clinical trials. Medinfo. 8 (2); 1097.

Hollingsworth, R. & Richards, B. (1995). A Multi-Media Hospital Equipment Database. MEDINFO 95 Proceedings, Eds. R.A.Greenes et al. North-Holland Publishing Company, pp624-25.

Hopp, D. I. (1998). Three Topics Integral To The Use of The Internet For Clinical Trials: Connectivity, Communication & Security. Drug Information Journal. 32; 933-939.

Hyde, A. W. (1998). The Changing Face Of Electronic Data Capture: From Remote Data Entry To Direct Data Capture. Drug Information Journal. 32; 1089-1092.

Hyland, M. E., Kenyon, C. A. P., Allen, R. et al (1993). Diary keeping in asthma; comparison of eletronic and written methods. British Medical Journal. 306; 487-489.

Kelly, M. A. & Oldham, J. (1997). The Internet and randomised controlled trials. Int. J. Med. Inf. 47 (1-2); 91-99.

Kiuchi, T., Ohashi, Y., Konishi, M. et al (1996). A world wide web-based user interface for a data management system for use in multi-institutional clinical trials — development and experimental operation of an automated patient registration allocation system. Control Clinical Trials. 17; 476-493.

Kohane, I. S., Greenspun, P. Fackler, J. et al (1996). Building national electronic medical record systems via the world wide web. Journal of the American Medical Information Association. 3; 191-207.

Kubick, W. R. (1998). The Elegant Machine: Applying Technology to Optimise Clinical Trials. Drug Information Journal. 32; 861-869.

Kush, R. D. (1999). Electronic Data Capture: A Survey. The Monitor. Fall 1999; 37-40.

Lampe, A. J. & Weiler, J. M. (1998). Data Capture From Investigators’ & Sponsors’ Perspectives: Balancing Quality, Speed & Cost. Drug Information Journal. 32; 871-886.

Latham, D. (1998). EDC: Estbalishing Standards for Electronic Data Capture. Interview of K. Valiant. Pharmaceutical Visions. Autumn 1998.

Lawson, Brown & Shostak (1997). Results of a data imaging pilot project. Drug Information Journal. 31; 194-195.

Lightfoot, Getz et al (1998). Faster time to market, ACRP’s white paper on future trends. Applied Clinical Trials. 66.

Menduno, M. (1998). Prognosis: wired. Why Internet technology is the next medical breakthrough. Hospital Health Network. 72 (21); 28-30, 32-35.

Nakamura, A. & Matsuto, Baba M. (1998). Communications between hospital laboratory personnel and physicians. Rinsho Byori. 46 (11); 1103-1110.

Perkins, R (Manuscript in preparation). Managing The Information Process: Electronic Data Capture — An Inadequate Term.

Regalado, A. (1998). Re-engineering drug development, II: Clinical data collection and management. Start-up. 27.

Schoichet, Creasey & Kasay. (1998). System infrastructure for Sponsor/CRO collaboration on international clinical trials. Drug Information Journal. 32; 155-161.

Stokes, T. Computer systems validation (6-part series). Applied Clinical Trials. September 1996, January 1997, February 1997, April 1997, June 1997, August 1997.

Tiplady, C. et al (1997). The use of electronic diaries in respiratory studies. Drug Information Journal. 31; 759-764.

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