Revision of the ICH guideline on clinical safety data management : data elements for transmission of individual case safety reports.

Format:

Book

Conference/Event

Government document

Contributor:

Center for Drug Evaluation and Research (U.S.)

Center for Biologics Evaluation and Research (U.S.)

Conference Name:

International Conference on Harmonisation http://viaf.org/viaf/130234339

Language:

English

Subjects (All):

Clinical pharmacology.

Clinical trials--Reporting.

Clinical trials.

Drugs--Testing.

Drugs.

Physical Description:

1 online resource (25 pages)

Other Title:

PDF cover has title: E2B(R) clinical safety data management

Data elements for transmission of individual case safety reports

Place of Publication:

[Rockville, MD] : [Center for Drug Evaluation and Research] : [Center for Biologics Evaluation and Research], [2005]

Notes:

Title from PDF title page (viewed on June 18, 2009).

"ICH harmonised tripartite guideline."

"Version 2.0."

"12 May 2005."

OCLC:

402677963