UID:
almafu_9959328458002883
Format:
1 online resource (xviii, 406 pages) :
,
illustrations
Edition:
2nd ed.
ISBN:
9781444315219
,
1444315218
,
9781444315226
,
1444315226
Content:
As the number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.: Includes a manual for investigators, research nurses and study coordinators with minimal exp.
Note:
Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.
,
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.
Additional Edition:
Print version: Liu, Margaret B. Clinical trials manual from the Duke Clinical Research Institute. Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010 ISBN 9781405195157
Language:
English
Keywords:
Handbooks, manuals, etc.
;
Electronic books.
;
Handbooks and manuals.
;
Handbooks, manuals, etc.
;
Electronic books.
;
Handbooks and manuals.
;
Handbooks, manuals, etc.
;
Electronic books.
;
Handbooks and manuals.
DOI:
10.1002/9781444315219
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9781444315219
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9781444315219
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9781444315219
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