Electronic health records, medical research, and the tower of babel

New England Journal of Medicine

Volumn 358, Issue 16, 2008, Pages 1738-

  Kush, Rebecca D ^a   Helton, Edward ^b   Rockhold, Frank W ^c   David Hardison, C ^d  

^a Clinical Data Interchange Standards Consortium   (United States)

^b SAS INSTITUTE INC   (United States)

^c GLAXOSMITHKLINE   (United States)

^d SCIENCE APPLICATIONS INTERNATIONAL CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORRELATION ANALYSIS; DATA BASE; DEMOGRAPHY; ELECTRONIC MEDICAL RECORD; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; MEDICAL INFORMATION; MEDICAL PRACTICE; MEDICAL RESEARCH; PHYSICIAN; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; SHORT SURVEY;

EID: 42249106703     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsb0800209     Document Type: Article

References (4)

1. Clinical Data Interchange Standards Consortium. Electronic Source Data Interchange (sSDI) Group. Leveraging the CDISC standards to facilitate the use of electronic source data within clinical trials. (Accessed March 28, 2008, at http://www.cdisc.org/eSDI/eSDI.pdf.)
2. Study data specifications referenced in final guidance for industry: providing regulatory submissions in electronic format - human pharmaceutical applications and related submissions: using the eCTD specifications. (Accessed March 28, 2008, at http://www.fda.gov/cder/regulatory/ersr/Studydata.pdf.)
3. Food and Drug Administration. Critical path initiative. (Accessed March 28, 2008, at http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.)
4. Rozwell C, Kush R, Helton E. Saving time and money. Appl Clin Trials 2007;16(6):70-4.