عنوان
پدید آورنده
موضوع
رده
R856.4 .A23 2009
R856
.
4
.
A23
2009
کتابخانه
محل استقرار
0470474262 (cloth)
0470475919
9780470474266 (cloth)
9780470475911
bnb
b427152
Design, execution, and management of medical device clinical trials /
[Book]
Salah Abdel-aleem
Hoboken, N.J. :
John Wiley & Sons,
c2009
xxi, 272 p. :
ill. ;
25 cm
Includes bibliographical references and index
An overview of clinical study tasks and activities -- Development of the clinical protocols, case report forms, clinical standard operating procedures, informed consent form, study regulatory binder, study research agreement, and other clinical materials -- Qualification/selection of investigators and study monitoring visits -- Adverse events definitions and reporting procedures -- Statistical analysis plan (SAP) and biostastics in clinical research -- Final clinical study report -- Medical device regulations, combination product, study committees, and FDA-sponsor meetings -- Design issues in medical device studies -- Investigator-initiated clinical research -- Ethical conduct for human research -- Glossary of clinical trial and statistical terms
0
Clinical trials
Medical instruments and apparatus-- Research
Clinical Trials as Topic-- methods
Device Approval-- standards
Equipment and Supplies-- standards
Evaluation Studies as Topic
610
.
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R856
.
4
.
A23
2009
2009
J-792
W
26
A135d
2009
Abdel-aleem, Salah
20100716160043.0
مطالعه متن کتاب [Book]
Y
