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003 OCoLC;

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006 m d f ;

007 cr a||||||||||;

008 090512s2006 mdu o f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0475 (online);

086 0 a| HE 20.4002:R 25/2;

245 00 a| Guidance for clinical investigators, institutional review boards, and sponsors :b| process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.;

246 30 a| Process for handling referrals to FDA under 21 CFR 50.54;

246 30 a| Additional safeguards for children in clinical investigations;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration,c| [2006];

300 a| i, 9 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 5/12/09: http://www.fda.gov/cber/gdlns/childclininv.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on May 12, 2009).;

500 a| "December 2006".;

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

650 0 a| Medical research personnelx| Government policyz| United States.=| ^A827174;

650 0 a| Clinical trialsx| Government policyz| United States.=| ^A11330;

710 1 a| United States.b| Food and Drug Administration.=| ^A1253;

856 40 u| https://purl.fdlp.gov/GPO/LPS112485;

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

596 a| 1;

998 a| 1899053;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1899053-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/14/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for clinical investigators, institutional review boards, and sponsors : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.

Other author	United States. Food and Drug Administration.
Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [2006]
Description	i, 9 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS112485
Subjects	Medical research personnel--Government policy. --United States. Clinical trials--Government policy. --United States. Pediatrics--Research. --Government policy. --United States.

Portion of title	Process for handling referrals to FDA under 21 CFR 50.54
Portion of title	Additional safeguards for children in clinical investigations
General note	Title from PDF title page (viewed on May 12, 2009).
General note	"December 2006".
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA CBER web site. Address as of 5/12/09: http://www.fda.gov/cber/gdlns/childclininv.pdf ; current access is available via PURL.
GPO item number	0475 (online)
Govt. docs number	HE 20.4002:R 25/2

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	Electronic Resources	Access Content Online	✔ Available

Guidance for clinical investigators, institutional review boards, and sponsors : process for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations.

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