MARC details
| 000 -LEADER |
| fixed length control field |
07383cam a2201045 a 4500 |
| 001 - CONTROL NUMBER |
| control field |
ocn162571734 |
| 003 - CONTROL NUMBER IDENTIFIER |
| control field |
OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
| control field |
20240925150334.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS |
| fixed length control field |
m d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
| fixed length control field |
cr cn||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
| fixed length control field |
070806s2006 mau ob 001 0 eng d |
| 040 ## - CATALOGING SOURCE |
| Original cataloging agency |
OPELS |
| Language of cataloging |
eng |
| Description conventions |
pn |
| Transcribing agency |
OPELS |
| Modifying agency |
OKU |
| -- |
OCLCQ |
| -- |
N$T |
| -- |
YDXCP |
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OCLCO |
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EBLCP |
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MHW |
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MERUC |
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UKWOH |
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IDEBK |
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UBY |
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E7B |
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OCLCQ |
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OCLCF |
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OCLCQ |
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NLGGC |
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CHVBK |
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NRU |
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OCLCQ |
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AGLDB |
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STF |
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CCO |
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MOR |
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PHUST |
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OCLCO |
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IQW |
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JBG |
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OCLCO |
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PIFAG |
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ZCU |
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OCLCQ |
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CASUM |
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OCLCO |
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U3W |
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OCLCA |
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MNS |
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OCLCO |
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KIJ |
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WRM |
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VNS |
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OCLCO |
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D6H |
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OCLCO |
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ACO |
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WCO |
| -- |
OCLCO |
| -- |
OCLCQ |
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VTS |
| -- |
OCLCO |
| -- |
NRAMU |
| -- |
XOS |
| -- |
ICG |
| -- |
OCLCO |
| -- |
OCLCQ |
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VT2 |
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REC |
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OCLCO |
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AU@ |
| -- |
OCLCO |
| -- |
OCLCQ |
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OCLCO |
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WYU |
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OCLCO |
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S9I |
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TKN |
| -- |
OCLCO |
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LEAUB |
| -- |
OCLCO |
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DKC |
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OCLCO |
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OCLCQ |
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OCLCO |
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M8D |
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OCLCO |
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OL$ |
| -- |
OCLCQ |
| -- |
OCLCO |
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OCLCQ |
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K6U |
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OCLCA |
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VLY |
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OCLCQ |
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OCLCO |
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OCLCQ |
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IOY |
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OCLCQ |
| -- |
OCL |
| -- |
OCLCO |
| 015 ## - NATIONAL BIBLIOGRAPHY NUMBER |
| National bibliography number |
GBA4Y1082 |
| Source |
bnb |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
| Record control number |
101258295 |
| Source |
DNLM |
| 019 ## - |
| -- |
76697795 |
| -- |
85766756 |
| -- |
441762043 |
| -- |
505064176 |
| -- |
647545036 |
| -- |
701878860 |
| -- |
814467746 |
| -- |
823136810 |
| -- |
843151739 |
| -- |
961552298 |
| -- |
962560748 |
| -- |
1162253939 |
| -- |
1228531159 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
9780122107511 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
0122107519 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
0080454208 |
| Qualifying information |
(electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
9780080454207 |
| Qualifying information |
(electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
1280633417 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
9781280633416 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
9786610633418 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
661063341X |
| 024 3# - OTHER STANDARD IDENTIFIER |
| Canceled/invalid standard number or code |
9780122107511 |
| 035 ## - SYSTEM CONTROL NUMBER |
| System control number |
166146 |
| -- |
(N$T) |
| 035 ## - SYSTEM CONTROL NUMBER |
| System control number |
(OCoLC)162571734 |
| Canceled/invalid control number |
(OCoLC)76697795 |
| -- |
(OCoLC)85766756 |
| -- |
(OCoLC)441762043 |
| -- |
(OCoLC)505064176 |
| -- |
(OCoLC)647545036 |
| -- |
(OCoLC)701878860 |
| -- |
(OCoLC)814467746 |
| -- |
(OCoLC)823136810 |
| -- |
(OCoLC)843151739 |
| -- |
(OCoLC)961552298 |
| -- |
(OCoLC)962560748 |
| -- |
(OCoLC)1162253939 |
| -- |
(OCoLC)1228531159 |
| 037 ## - SOURCE OF ACQUISITION |
| Stock number |
90127:90127 |
| Source of stock number/acquisition |
Elsevier Science & Technology |
| Note |
http://www.sciencedirect.com |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
| Classification number |
R853.P75 |
| Item number |
D47 2006eb |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
| Classification number |
2005 L-599 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
| Classification number |
W 20.5 |
| Item number |
D431w 2006 |
| 072 #7 - SUBJECT CATEGORY CODE |
| Subject category code |
HEA |
| Subject category code subdivision |
032000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
| Subject category code |
MED |
| Subject category code subdivision |
034000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
| Subject category code |
HEA |
| Subject category code subdivision |
009000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
| Subject category code |
OCC |
| Subject category code subdivision |
011000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
| Subject category code |
MJ |
| Source |
bicssc |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
| Classification number |
615.50724 |
| Edition number |
22 |
| 049 ## - LOCAL HOLDINGS (OCLC) |
| Holding library |
MAIN |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
| Personal name |
DeRenzo, Evan G. |
| 9 (RLIN) |
110716 |
| 245 10 - TITLE STATEMENT |
| Title |
Writing clinical research protocols : |
| Remainder of title |
ethical considerations / |
| Statement of responsibility, etc. |
Evan G. DeRenzo and Joel Moss. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
| Place of publication, distribution, etc. |
Burlington, MA ; |
| -- |
London : |
| Name of publisher, distributor, etc. |
Elsevier Academic, |
| Date of publication, distribution, etc. |
©2006. |
| 300 ## - PHYSICAL DESCRIPTION |
| Extent |
1 online resource (xix, 300 pages) |
| 336 ## - CONTENT TYPE |
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
| File type |
data file |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
| Formatted contents note |
Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience. |
| 520 ## - SUMMARY, ETC. |
| Summary, etc. |
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations. |
| 505 0# - FORMATTED CONTENTS NOTE |
| Formatted contents note |
What You Need To Know About Research Ethics Before Deciding on What You Want To Study -- Designing a Clinical Research Study -- Writing Consent and Assent Documents -- Getting the Protocol Approved -- Conducting the Study; Special Populations -- Ethical Considerations in Genetics Research -- Ethical Considerations in Use of Tissue for Laboratory Investigations -- Ethical Considerations in Use of Stored Tissue -- Confidentiality Issues -- Research in Emergency Medicine -- Reporting of Adverse Events -- FDA -- Radiation Safety Issues -- Participation of Subjects in Multi-Site Trials -- Participation of Subjects in Multiple Studies -- Conduct of Pharmaceutical Industry Research -- Case Histories, Learning from Experience -- Appendix. |
| 588 0# - SOURCE OF DESCRIPTION NOTE |
| Source of description note |
Print version record. |
| 546 ## - LANGUAGE NOTE |
| Language note |
English. |
| 590 ## - LOCAL NOTE (RLIN) |
| Local note |
Added to collection customer.56279.3 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical trials. |
| 9 (RLIN) |
94114 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Human experimentation in medicine. |
| 9 (RLIN) |
166546 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Medical protocols. |
| 9 (RLIN) |
80789 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Writing. |
| 9 (RLIN) |
5902 |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Biology |
| General subdivision |
research |
| 9 (RLIN) |
87200 |
| 650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical Trials |
| 9 (RLIN) |
94114 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Human Experimentation |
| 9 (RLIN) |
110717 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical Protocols |
| 9 (RLIN) |
80784 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Writing |
| 9 (RLIN) |
5902 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Ethics |
| 9 (RLIN) |
6045 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Biomedical Research |
| General subdivision |
ethics |
| 9 (RLIN) |
110718 |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical Protocols |
| General subdivision |
standards |
| 9 (RLIN) |
110719 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Études cliniques. |
| 9 (RLIN) |
110720 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Expérimentation humaine en médecine. |
| 9 (RLIN) |
337617 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Protocoles médicaux. |
| 9 (RLIN) |
378957 |
| 650 #6 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Écriture. |
| 9 (RLIN) |
151488 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
writing (processes) |
| Source of heading or term |
aat |
| 9 (RLIN) |
990478 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
HEALTH & FITNESS |
| General subdivision |
Alternative Therapies. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
110721 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
MEDICAL |
| General subdivision |
Healing. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
110722 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
HEALTH & FITNESS |
| General subdivision |
Healing. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
110723 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
BODY, MIND & SPIRIT |
| General subdivision |
Healing |
| -- |
General. |
| Source of heading or term |
bisacsh |
| 9 (RLIN) |
110724 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Writing |
| Source of heading or term |
fast |
| 9 (RLIN) |
5902 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Medical protocols |
| Source of heading or term |
fast |
| 9 (RLIN) |
80789 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Human experimentation in medicine |
| Source of heading or term |
fast |
| 9 (RLIN) |
166546 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical trials |
| Source of heading or term |
fast |
| 9 (RLIN) |
94114 |
| 655 #0 - INDEX TERM--GENRE/FORM |
| Genre/form data or focus term |
Electronic books. |
| 9 (RLIN) |
396 |
| 655 #2 - INDEX TERM--GENRE/FORM |
| Genre/form data or focus term |
Electronic information resources [MESH] |
| 9 (RLIN) |
110725 |
| 655 #2 - INDEX TERM--GENRE/FORM |
| Genre/form data or focus term |
Electronic information resources |
| 9 (RLIN) |
107125 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
| Personal name |
Moss, Joel. |
| 9 (RLIN) |
102665 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
| Relationship information |
Print version: |
| Main entry heading |
DeRenzo, Evan G. |
| Title |
Writing clinical research protocols. |
| Place, publisher, and date of publication |
Burlington, MA ; London : Elsevier Academic, ©2006 |
| International Standard Book Number |
9780122107511 |
| -- |
0122107519 |
| Record control number |
(OCoLC)56453025 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
| Materials specified |
EBSCOhost |
| Uniform Resource Identifier |
<a href="https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=166146">https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=166146</a> |
| 938 ## - |
| -- |
ProQuest Ebook Central |
| -- |
EBLB |
| -- |
EBL269513 |
| 938 ## - |
| -- |
ebrary |
| -- |
EBRY |
| -- |
ebr10138125 |
| 938 ## - |
| -- |
EBSCOhost |
| -- |
EBSC |
| -- |
166146 |
| 938 ## - |
| -- |
ProQuest MyiLibrary Digital eBook Collection |
| -- |
IDEB |
| -- |
63341 |
| 938 ## - |
| -- |
YBP Library Services |
| -- |
YANK |
| -- |
2491273 |
| 994 ## - |
| -- |
92 |
| -- |
N$T |