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Biology of Blood and Marrow Transplantation
Volumn 8, Issue 6, 2002, Pages 295-302
Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devices: A report from the William Guy Forbeck Foundation 2001 Focus Meeting on clinical trials in hematopoietic stem cell transplantation
Author keywords

Adverse events; Hematopoietic stem cell transplantation; Monitoring
Indexed keywords

NEW DRUG;
EID: 0036063859     PISSN: 10838791     EISSN: None     Source Type: Journal    
DOI: 10.1053/bbmt.2002.v8.pm12108915     Document Type: Article
Times cited : (8)
References (12)
  • 1
    • 85031461550 scopus 로고    scopus 로고
    • 21 CFR §312.32
  • 2
    • 85031461296 scopus 로고    scopus 로고
    • 21 CFR §312.33(b)(1)
  • 3
    • 85031461063 scopus 로고    scopus 로고
    • 21 CFR §312.64
  • 4
    • 85031455600 scopus 로고    scopus 로고
    • 21 CFR §312.62
  • 5
    • 85031452873 scopus 로고
    • International Conference on Harmonization. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. Geneva, Switzerland: International Conference on Harmonization; October 27
    • (1994)
  • 6
    • 0005653305 scopus 로고    scopus 로고
    • International Conference on Harmonization. Guideline for Good Clinical Practice. Geneva, Switzerland: International Conference on Harmonization; May 1
    • (1996)
  • 7
    • 85031456867 scopus 로고
    • International Conference on Harmonization. Structure and Content of Clinical Study Reports. Geneva, Switzerland: International Conference on Harmonization; November 30
    • (1995)
  • 8
    • 85031453543 scopus 로고    scopus 로고
    • National Cancer Institute, Cancer Therapy Evaluation Program. Common Toxicity Criteria Manual. Bethesda, Md: National Cancer Institute; June 1
    • (1999)
  • 9
    • 85031462623 scopus 로고    scopus 로고
    • National Cancer Institute, Cancer Therapy Evaluation Program. Common Toxicity Criteria. Version 2.0. Bethesda, Md: National Cancer Institute; April 30
    • (1999)
  • 10
    • 85031456111 scopus 로고    scopus 로고
    • National Cancer Institute, Cancer Therapy Evaluation Program. NCI Guidelines: Expedited Adverse Event Reporting Requirements for NCI Investigational Agents. Bethesda, Md: National Cancer Institute; January
    • (2001)
  • 11
    • 85031464086 scopus 로고    scopus 로고
    • Food and Drug Administration. Cancer Drug and Biological Products-Clinical Data in Marketing Applications. Rockville, Md: Food and Drug Administration; October 5, (Docket No. 00D-1562)
    • (2001)
  • 12
    • 0031053664 scopus 로고    scopus 로고
    • Clinical trial safety surveillance in the new regulatory and harmonization environment: Lessons learned from the "fialuridine crisis"
    • (1997) Drug Inf. J , vol.31 , pp. 63-70
    • Nikas, J.1

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.