عنوان
پدید آورنده
موضوع
رده
R853.C55 C585 2004eb
R853
.
C55
C585
2004eb
کتابخانه
محل استقرار
0203492064
0849321816
9780203492062
9780849321818
0849321816
b706953
Handbook of SOPs for good clinical practice /
[Book]
Celine Clive.
2nd ed.
Boca Raton :
Interpharm/CRC Press,
©2004.
1 online resource (270 pages) :
illustrations
Revised edition of: A handbook of SOPs for good clinical practice / Donald E. Maynard, B. Joyce Baird. c1996.
Includes bibliographical references and index.
Front Cover; Table of Contents; MON-001.0: Preparation, Issue, and Revision of Standard Operating Procedures (SOPs); MON-002.0: Training Clinical Research Staff; MON-003.0: Selecting Investigators and Study Sites; MON-004.0: Developing Informed Consent Forms; MON-005.0: Conducting Site Evaluation Visits; MON-006.0: Conducting Study Initiation Visits; MON-007.0: Conducting Periodic Site Visits; MON-008.0: Reviewing Case Report Forms at the Study Site; MON-009.0: Reviewing Regulatory Documents; MON-010.0: Adverse Experiences (AEs), Serious Adverse Experiences (SAEs), and IND Safety Reports.
0
Completely revised and updated, this second edition of a classic handbook provides templates of SOPs ready for immediate adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that readers can easily modify the text to reflect their organization's processes. The language ranges from the specific to the very general, depending on the activity described and the number of the existing regulations governing it. The handboo.
Ingram Content Group
TANDF_194869
Handbook of SOPs for good clinical practice.
0849321816
Handbook of standard operating procedures for good clinical practice
Clinical trials-- Standards, Handbooks, manuals, etc.
Clinical trials, Forms, Handbooks, manuals, etc.
Clinical Trials-- standards.
Human Experimentation-- standards.
Legislation, Drug.
Research-- standards.
Clinical trials-- Standards.
Clinical trials.
MEDICAL-- Laboratory Medicine.
MED-- 047000
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R853
.
C55
C585
2004eb
2004
E-403
W
49
C642h
2004
Clive, Celine.
Maynard, Donald E.
20201207220733.0
pn
مطالعه متن کتاب [Book]
Y
