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001 ocn694600449;

003 OCoLC;

005 20141212065450.0;

008 101223s2011 sz b 001 0 eng ;

010 a| 2010053999;

016 7 a| 1015502452| DNLM;

020 a| 9783805596848 (spiral bound soft cover : alk. paper);

020 a| 3805596847 (spiral bound soft cover : alk. paper);

020 a| 9783805596855 (e-ISBN);

020 a| 3805596855 (e-ISBN);

029 1 a| NLMb| 101550245;

035 a| (Sirsi) o694600449;

035 a| (OCoLC)694600449;

042 a| pcc;

049 a| NEHH;

050 00 a| R853.C55b| F672 2011;

060 10 a| W 20.5;

082 00 a| 615.5072/42| 22;

100 1 a| Fortwengel, Gerhard.;

245 10 a| Guide for investigator initiated trials /c| Gerhard Fortwengel.;

300 a| 148 pages ;c| cm.;

336 a| text2| rdacontent;

337 a| unmediated2| rdamedia;

338 a| volume2| rdacarrier;

504 a| Includes bibliographical references and index.;

505 0 a| Risk-benefit analysis -- Study types and study design -- Investigational medicinal products -- Study protocol -- Case report forms -- Financing -- Qualifications, CVS of site staff, training, delegation of authority -- EudraCT -- Contracts -- Informed consent -- Investigator's brochure/summary of product characteristics -- Insurance -- Health authority approval -- Ethics -- Trial master file, updating and archiving -- Documentation -- Data management -- Screening -- Pharmacovigilance -- Patient compliance -- Source data verification -- Quality -- Monitoring -- Biometry -- Multicentre trials -- Final study report and publication.;

650 0 a| Clinical trials.;

650 12 a| Clinical Trials as Topic.;

650 22 a| Research Design.;

938 a| YBP Library Servicesb| YANKn| 3615446;

949 a| W 20.5 F745g 2011h| HSL70i| 31740007291614o| hercp| $49.95;

949 a| W 20.5 F745g 2011 AVh| HSL4i| 31740007291648o| herc;

994 a| C0b| NEH;

096 a| W 20.5 F745g 2011;

590 a| Laupus-WCP;

096 a| W 20.5 F745g 2011;

596 a| 4;

998 a| 2507542;

999 a| W 20.5 F745G 2011w| NLMc| 1i| 31740007291614d| 7/8/2011e| 7/1/2011l| HSLBKm| HSLp| $49.95q| 1r| Ys| Yt| HBKu| 7/1/2011x| BOOKz| HSTACKSo| .STAFF. herc;

Guide for investigator initiated trials / Gerhard Fortwengel.

Author/creator	Fortwengel, Gerhard
Format	Book
Publication Info	Basel : Karger, ©2011.
Description	148 pages ; cm.
Subjects	Clinical trials. Clinical Trials as Topic. Research Design.

Contents	Risk-benefit analysis -- Study types and study design -- Investigational medicinal products -- Study protocol -- Case report forms -- Financing -- Qualifications, CVS of site staff, training, delegation of authority -- EudraCT -- Contracts -- Informed consent -- Investigator's brochure/summary of product characteristics -- Insurance -- Health authority approval -- Ethics -- Trial master file, updating and archiving -- Documentation -- Data management -- Screening -- Pharmacovigilance -- Patient compliance -- Source data verification -- Quality -- Monitoring -- Biometry -- Multicentre trials -- Final study report and publication.
Local note	Laupus-WCP
Bibliography note	Includes bibliographical references and index.
LCCN	2010053999
ISBN	9783805596848 (spiral bound soft cover : alk. paper)
ISBN	3805596847 (spiral bound soft cover : alk. paper)
ISBN	9783805596855 (e-ISBN)
ISBN	3805596855 (e-ISBN)

Guide for investigator initiated trials / Gerhard Fortwengel.

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