MARC details
| 000 -LIDER |
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| fixed length control field |
05047nam a22006495i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-3-031-28760-2 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20240207153613.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
230608s2023 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9783031287602 |
| -- |
978-3-031-28760-2 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RM300-666 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
MMG |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
MED071000 |
| Source |
bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
MKG |
| Source |
thema |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
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| Title |
Data Monitoring Committees (DMCs) |
| Medium |
[electronic resource] : |
| Remainder of title |
Past, Present, and Future / |
| Statement of responsibility, etc. |
edited by Nand Kishore Rawat, David Kerr. |
| 250 ## - EDITION STATEMENT |
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| Edition statement |
1st ed. 2023. |
| 264 #1 - |
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| -- |
Cham : |
| -- |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| -- |
2023. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
XII, 111 p. 1 illus. |
| Other physical details |
online resource. |
| 336 ## - |
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| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
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| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
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| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 347 ## - |
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| -- |
text file |
| -- |
PDF |
| -- |
rda |
| 500 ## - GENERAL NOTE |
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| General note |
Acceso multiusuario |
| 505 0# - FORMATTED CONTENTS NOTE |
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| Formatted contents note |
Introduction-.What is a DMC?-. Is a DMC required?-. Who is On the DMC?-. What are the Legal and Ethical Aspects of DMC?-. How does the DMC work with SDAC and Sponsor and External Groups ? -- What Does a DMC Meeting Look Like -- What data is used for DMC outputs and who programs? -- What is Included in DMC Outputs? -- What does the DMC final DMC outputs look like and how is it delivered? -- What Types of Safety Outputs Does the DMC Receive? -- What types of efficacy outputs does the DMC receive? -- What types of other outputs does the DMC receive? -- What About In-Between DMC Meetings -- What types of formal interim analyses does the DMC review? -- What does the paperwork from meetings look like? -- How does the DMC assess risk-benefit for their decision making? -- What are some examples? -- Conclusions. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
This book provides an overview of Data Monitoring Committees - what was done in the past, what is currently being done, and thoughts on improvements for the future. Previous works focused primarily on large cardiovascular studies (where DMCs originated more than 30 years ago) but updated references are needed that discuss smaller, more flexible studies in areas such as oncology. The authors have attended ~800 DMC meetings from ~200 distinct studies across all areas of clinical studies (oncology, rheumatology, rare diseases, cardiology, immunology, etc.) This wide range of expertise will be used, as well as the expertise that comes from working with virtually every large biotech/pharma and CRO for DMC work. The reader of the book will know when DMCs are needed or helpful, how to form the DMC, how to work with external CROs and with sponsor teams and the DMC to create needed DMC outputs, how the DMC meetings are conducted, and - especially for DMC members - what are considerations within the Closed Session to review safety/efficacy outputs to assess risk/benefit to make appropriate recommendations that protect the patient safety and trial integrity. This is a practical hands-on book on how to decide if a DMC is necessary, how to form the DMC, how to smoothly create the necessary materials for the DMC and have smooth running DMC meetings. There is no specialized training in school about how DMCs work - frequently people may have been in industry for many years without ever needing to work with a DMC. This book is the helpful reference for those new to these DMCs. The DMC work is critical to be correctly implemented as the implications of it are so great. This book provides the following: Thorough instructions on the steps needed to form and implement a Data Monitoring Committee for clinical trial evaluation; Includes practical and hands-on information on DMC implementation; Discusses a wide range of clinical trial - by phase and therapeutic area. |
| 541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE |
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| Owner |
UABC ; |
| Method of acquisition |
Perpetuidad |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Pharmacology. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Medical sciences. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Drug development. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Medicine |
| Subdivisión general |
Research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Biology |
| Subdivisión general |
Research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Pharmaceutical chemistry. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Biometry. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Toxicology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Pharmacology. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Preclinical Research. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Biomedical Research. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Pharmaceutics. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Término temático o nombre geográfico como elemento de entrada |
Biostatistics. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Término temático o nombre geográfico como elemento de entrada |
Medical Toxicology. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Rawat, Nand Kishore. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
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| Personal name |
Kerr, David. |
| Relator term |
editor. |
| Relator code |
edt |
| -- |
http://id.loc.gov/vocabulary/relators/edt |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
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| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
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| Title |
Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
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| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031287596 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031287619 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9783031287626 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
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| Public note |
Libro electrónico |
| Uniform Resource Identifier |
http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-28760-2 |
| 912 ## - |
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ZDB-2-SBL |
| 912 ## - |
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ZDB-2-SXB |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Libro Electrónico |
