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Guidance for clinical investigators, sponsors, and IRBs : adverse event reporting to IRBs : improving human subject protection.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2009]
2009
1 resource
Available online
Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.
Web resource
[Rockville, MD] : [Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research], [2005]
2005
1 resource
Available online
Guidance for industry : E2B(M), data elements for transmission of individual case study reports, questions and answers.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
2005
1 resource
Available online
Guidance for industry : E2BM data elements for transmission of individual case safety reports.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2002]
2002
1 resource
Available online
Guidance for industry : granularity document : annex to M4, organization of the CTD.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005]
2005
1 resource
Available online
Guidance for industry : M4, the CTD, efficacy questions and answers.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
2004
1 resource
Available online
Guidance for industry : M4, the CTD, general questions and answers.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2004]
2004
1 resource
Available online
Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.
Web resource
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001]
2001
1 resource
Available online
Clinical trial registries : a practical guide for sponsors and researchers of medicinal products / edited by MaryAnn Foote.
Book/text
Basel ; Boston : Birkhäuser Verlag, [2006], ©2006.
2006
1 item
Call number | R853.C55 C576 2006 |
Item location | Off-site |