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001 ocn320776791;

003 OCoLC;

005 20120709151712.0;

006 m o d f ;

007 cr b||||||||||;

008 090511s2007 mdu ob f000 0 eng d;

043 a| n-us---;

049 a| ERE#;

074 a| 0475 (online);

086 0 a| HE 20.4002:C 73/3z| HE 20.4002:C 73;

245 00 a| Guidance for industry :b| computerized systems used in clinical investigations.;

246 30 a| Computerized systems used in clinical investigations;

260 a| [Rockville, MD] :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner,c| [2007];

300 a| 10 p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA CBER web site. Address as of 5/11/09: http://www.fda.gov/cber/gdlns/compclintrial.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed May 11, 2009).;

500 a| "May 2007.";

500 a| GPO Cataloging Record Distribution Program (CRDP).;

504 a| Includes bibliographical references (p. 9).;

650 0 a| Computer systemsz| United States.=| ^A148010;

650 0 a| Clinical trialsz| United States.=| ^A1000929;

710 1 a| United States.b| Food and Drug Administration.b| Office of the Commissioner.=| ^A691845;

856 40 u| https://purl.fdlp.gov/GPO/LPS112457;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 1899033;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1899033-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/14/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for industry : computerized systems used in clinical investigations.

Other author	United States. Food and Drug Administration. Office of the Commissioner.
Format	Electronic
Publication Info	[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2007]
Description	10 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS112457
Subjects	Computer systems--United States. Clinical trials--United States.

Portion of title	Computerized systems used in clinical investigations
General note	Title from PDF title page (viewed May 11, 2009).
General note	"May 2007."
General note	GPO Cataloging Record Distribution Program (CRDP).
Bibliography note	Includes bibliographical references (p. 9).
Technical details	Mode of access: Internet at the FDA CBER web site. Address as of 5/11/09: http://www.fda.gov/cber/gdlns/compclintrial.pdf ; current access is available via PURL.
GPO item number	0475 (online)
Govt. docs number	HE 20.4002:C 73/3 HE 20.4002:C 73

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Guidance for industry : computerized systems used in clinical investigations.

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