Research Catalog

Details

Additional authors

1. Center for Biologics Evaluation and Research (U.S.)
2. Center for Drug Evaluation and Research (U.S.)
3. Center for Devices and Radiological Health (U.S.)

Description

1. ii, 23 pages : digital, PDF file

Alternative title

1. On the establishment and operation of clinical trial data monitoring committees

Subject

1. Clinical trials > Government policy > United States

Call number

1. GPO Internet HE 20.4802:C 61/3

Note

1. Title from PDF title page (viewed on May 28, 2009).
2. "Draft guidance".
3. "November 2001".

System details (note)

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/clindatmon.pdf ; current access is available via PURL.

Title

1. Guidance for clinical trial sponsors : on the establishment and operation of clinical trial data monitoring committees.

Publisher

1. Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2001]

Type of content

1. text

Type of medium

1. computer

Type of carrier

1. online resource

System details

1. Mode of access: Internet at the FDA CBER web site. Address as of 5/28/09: http://www.fda.gov/cber/gdlns/clindatmon.pdf ; current access is available via PURL.

Connect to:

1. https://purl.fdlp.gov/GPO/LPS113180

Added author

1. Center for Biologics Evaluation and Research (U.S.)
2. Center for Drug Evaluation and Research (U.S.)
3. Center for Devices and Radiological Health (U.S.)

Gpo item no.

1. 0499-T-02 (online)

Sudoc no.

1. HE 20.4802:C 61/3