عنوان
پدید آورنده
موضوع
رده
R853.C55 L58 2010
R853
.
C55
L58
2010
کتابخانه
محل استقرار
1405195150
9781405195157
dltt
A clinical trials manual from the Duke Clinical Research Institute :
[Book]
lessons from a horse named Jim /
Margaret B. Liu and Kate Davis
2nd ed
Hoboken, NJ :
Wiley-Blackwell,
2010
xviii, 406 p. :
ill. ;
25 cm
Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
Includes bibliographical references and index
Lessons from a horse named Jim and other events in history affecting the regulation of clinical research -- The process : developing new drugs, biologics, and devices -- Good clinical practice and the regulations -- Informed consent and the regulations -- Institutional review boards -- Adverse events and unanticipated problems involving risks to subjects and others -- Monitoring, audits, and inspections -- The principal investigator, the clinical research coordinator, and the study site -- The protocol -- Study feasibility : reviewing a specific protocol -- Study activities -- Study documents/essential documents -- Management of study drugs, biologics, and devices -- Managing clinical trial data -- Global health and international trials
0
Clinical trials, Handbooks, manuals, etc
Drugs-- Testing, Handbooks, manuals, etc
Clinical Trials as Topic-- ethics-- United States
Clinical Trials as Topic-- legislation & jurisprudence-- United States
Device Approval-- United States
Drug Approval-- United States
615
.
5072/4
22
R853
.
C55
L58
2010
2010
B-988
QV
733
AA1
L783c
2010
Liu, Margaret B
Davis, Kate, (Kate G.)
Liu, Margaret B.
Duke Clinical Research Institute
20100507030700.0
مطالعه متن کتاب [Book]
Y
