Limit search to items available for checkout
Save Marked Records Save All On Page
Subjects (1-10 of 10)
Clinical trials -- Reporting.
1
2006
E-BOOK

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Book    AVAILABLE
2
2009
E-REPORT
Guidance for clinical investigators, sponsors, and IRBs adverse event reporting to IRBs : improving
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2009]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
3
2005
E-REPORT
Guidance for industry E2B(M), data elements for transmission of individual case study reports, quest
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
4
2002
E-REPORT
Guidance for industry E2BM data elements for transmission of individual case safety reports.
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
5
2005
E-REPORT
Guidance for industry granularity document : annex to M4, organization of the CTD.
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
6
2004
E-REPORT
Guidance for industry M4, the CTD, efficacy questions and answers.
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
7
2004
E-REPORT
Guidance for industry M4, the CTD, general questions and answers.
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
8
2001
E-REPORT
Guidance for industry submitting marketing applications according to the ICH-CTD format, general con
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]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
9
2015
E-BOOK

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Book    AVAILABLE
10
2005
E-REPORT
Revision of the ICH guideline on clinical safety data management data elements for transmission of
[Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2005]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
Save Marked Records Save All On Page
Locate in results