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Lessons from a horse named Jim : a clinical trials manual from the Duke Clinical Research Institute / by Margaret B. Liu and Kate Davis.

Holman Biotech Commons R853.C55 L58 2001
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LIBRA R853.C55 L58 2001
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Format:
Book
Author/Creator:
Liu, Margaret B.
Contributor:
Davis, Kate, 1960 February 23-
Duke Clinical Research Institute.
Language:
English
Subjects (All):
Pharmaceutical policy--United States.
Pharmaceutical policy.
Clinical trials.
History.
United States.
Drugs--Law and legislation--United States.
Drugs.
Drugs--Law and legislation.
Clinical trials--History.
Clinical Trials as Topic.
Antitoxins--pharmacology.
Technology, Pharmaceutical--standards.
Medical Subjects:
Clinical Trials as Topic.
Antitoxins--pharmacology.
Technology, Pharmaceutical--standards.
United States.
Physical Description:
xxiv, 279 pages : illustrations, charts, forms ; 25 cm
Place of Publication:
Durham, NC : Duke Clinical Research Institute, 2001.
Contents:
Lessons from a horse named Jim: a history of regulations affecting clinical research
The process: developing new drugs and devices
Good clinical practice and the regulations
Informed consent and the regulations
Adverse events
Monitoring
Deciding to be a Principal Investigator
The protocol
Study activities
Study documents
Study drug management
Patient data forms.
Notes:
Includes bibliographical references and index.
ISBN:
0971252904
OCLC:
49492134

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