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Volumn 41, Issue 3, 2007, Pages 373-382

Toward a comprehensive CDISC submission data standard

Author keywords

Analysis; CDISC; Clinical data standards; eCTD; Interoperability; Metadata; Submission

Indexed keywords

ARTICLE; CLINICAL DATA INTERCHANGE STANDARD CONSORTIUM; DATA ANALYSIS; DRUG INDUSTRY; DRUG INFORMATION; FOOD AND DRUG ADMINISTRATION; INFORMATION PROCESSING; MARKUP LANGUAGE; ORGANIZATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; STANDARDIZATION; STATISTICAL ANALYSIS;

EID: 34248346610     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150704100311     Document Type: Article
Times cited : (12)

References (10)
  • 2
    • 34248395692 scopus 로고    scopus 로고
    • November 26, Available at:, Accessed March 10
    • Christiansen D, Kubick W. The CDISC metadata model; November 26, 2001. Available at: http://www.cdisc.org/pdf/SubmissionMetadataModelV2.pdf. Accessed March 10, 2007.
    • (2001) The CDISC metadata model
    • Christiansen, D.1    Kubick, W.2
  • 3
    • 34248378845 scopus 로고    scopus 로고
    • Providing regulatory submissions in electronic format. Human pharmaceutical product applications and related submissions using the eCTD specifications; April 2006. Available at: http://www.fda.gov/cder/regulatory/ ersr/ectd.htm. Accessed March 10, 2007.
    • Providing regulatory submissions in electronic format. Human pharmaceutical product applications and related submissions using the eCTD specifications; April 2006. Available at: http://www.fda.gov/cder/regulatory/ ersr/ectd.htm. Accessed March 10, 2007.
  • 7
    • 34248396943 scopus 로고    scopus 로고
    • FDA announces standard format that drug sponsors can use to submit human drug clinical trial data, press release, P04-73; July 21, 2004. Accessed
    • March 10
    • FDA News. FDA announces standard format that drug sponsors can use to submit human drug clinical trial data, press release, P04-73; July 21, 2004. Accessed March 10, 2007.
    • (2007) FDA News
  • 8
    • 34248375796 scopus 로고    scopus 로고
    • Available at:, Accessed March 10, 2007
    • FDA study data specifications for eCTD submissions. Available at: http://www.fda.gov/cder/regulatory/ersr/Studydata-v1.2.pdf. Accessed March 10, 2007.
    • FDA study data specifications for eCTD submissions
  • 9
    • 34248347164 scopus 로고    scopus 로고
    • Paper FC03 presented at: PharmaSUG 2005. Available at:, Accessed March 10
    • Kenney S, Litzsinger M. Strategies for implementing SDTM and ADaM standards. Paper FC03 presented at: PharmaSUG 2005. Available at: http://www.lexjansen.com/pharmasug/2005/fdacompliance/fc03.pdf. Accessed March 10, 2007.
    • (2007) Strategies for implementing SDTM and ADaM standards
    • Kenney, S.1    Litzsinger, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.