The Resource A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim, Margaret B. Liu and Kate Davis, (electronic resource)

A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim, Margaret B. Liu and Kate Davis, (electronic resource)

Label
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim
Title
A clinical trials manual from the Duke Clinical Research Institute
Title remainder
lessons from a horse named Jim
Statement of responsibility
Margaret B. Liu and Kate Davis
Creator
k_tgFXlKNkY
Contributor
Subject
Genre
Language
eng
Cataloging source
NhCcYBP
http://library.link/vocab/creatorName
Liu, Margaret B
Dewey number
615.5072/4
Illustrations
illustrations
Index
index present
LC call number
R853.C55
LC item number
L58 2010
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
  • handbooks
NLM call number
  • 2010 B-988
  • QV 733 AA1
NLM item number
L783c 2010
http://library.link/vocab/relatedWorkOrContributorName
  • Davis, Kate
  • Liu, Margaret B
  • ebrary, Inc
http://library.link/vocab/subjectName
  • Clinical trials
  • Drugs
  • Clinical Trials as Topic
  • Clinical Trials as Topic
  • Device Approval
  • Drug Approval
Label
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim, Margaret B. Liu and Kate Davis, (electronic resource)
Link
http://site.ebrary.com/lib/umanitoba/docDetail.action?docID=10358922
Instantiates
Publication
Note
  • Description based on print version record
  • Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Postmarketing Surveillance of Drugs, Biologics, and Devices.
  • 3 Good Clinical Practice and the Regulations.
  • Good Clinical Practice.
  • Responsibilities in the Code of Federal Regulations.
  • Where to Obtain Information and Guidance for the Regulations and GCP.
  • 4 Informed Consent and the Regulations.
  • What Is Informed Consent?
  • Ethical Codes Regarding Informed Consent.
  • Regulatory Requirements for Informed Consent.
  • Informed Consent Process.
  • Machine generated contents note:
  • 5 Institutional Review Boards.
  • What is an Institutional Review Board?
  • IRB Activities.
  • Types of IRB Review.
  • Communication between IRBs and Investigators.
  • Communication between IRBs and Study Sponsors.
  • IRB Records and Reports.
  • Accreditation of IRBs.
  • Registration.
  • 6 Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others.
  • Foreword (Robert A. Harrington).
  • Why Collect Adverse Event Data?
  • Adverse Events.
  • Unanticipated Problems Involving Risks to Subjects or Others.
  • Investigator Responsibilities.
  • IRB Responsibilities.
  • Sponsor Responsibilities.
  • 7 Monitoring, Audits, and Inspections.
  • Monitoring Plan.
  • On-Site Monitoring.
  • In-House Monitoring.
  • Preface.
  • Audits and Inspections.
  • 8 The Principal Investigator, the Clinical Research Coordinator, and the Study Site.
  • Principal Investigator.
  • Staffing to Support Clinical Trials.
  • Space and Resource Needs.
  • Local Institutional Review Board.
  • 9 The Protocol.
  • Common Components of a Protocol.
  • Background and Rationale.
  • Study Organization.
  • List of Abbreviations.
  • Objectives/Endpoints.
  • Study Design.
  • Study Population.
  • Study Treatment Plan.
  • Safety Assessment, Management, and Reporting.
  • Replacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects.
  • Statistical Aspects.
  • Subject Data and Record Retention.
  • Monitoring.
  • 10 Study Feasibility: Reviewing a Specific Protocol.
  • 1 Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research.
  • Reviewing a Specific Protocol.
  • Should We Do this Study at Our Site?
  • 11 Study Activities.
  • Study Start-up Phase.
  • Study Maintenance Phase.
  • Study Completion and Close-Out Phase.
  • 12 Study Documents/Essential Documents.
  • Documents at Study Start-Up.
  • Documents While the Study is in Progress.
  • Documents at Study Close-out.
  • 2 The Process: Developing New Drugs, Biologics, and Devices.
  • Maintaining Your Site Study File.
  • 13 Management of Study Drugs, Biologics, and Devices.
  • Study Drugs and Biologics.
  • Study Devices.
  • 14 Managing Clinical Trial Data.
  • HIPAA, the Privacy Rule, and Clinical Trial Data.
  • Guidelines and Regulations Regarding Clinical Trial Data.
  • Study Site Responsibilities Regarding Clinical Trial Data.
  • Source Document Verification of Clinical Trial Data.
  • Release of Protected Medical Information.
  • Drug Development Process.
  • Confidentiality of Clinical Trial Data.
  • Endpoint Adjudication.
  • 15 Global Health and International Trials.
  • International Clinical Trials.
  • Ethnic and Racial Differences.
  • Ethical Issues and Cultural Sensitivities.
  • Why International Trials Are Important.
  • International Regulations.
  • Concerns.
  • Future Efforts.
  • Developing New Devices.
  • Appendices.
  • Epilogue (Lisa G. Berdan).
  • Glossary
Dimensions
unknown
Edition
2nd ed.
Extent
1 online resource.
Form of item
online
Isbn
9781444315226
Isbn Type
(electronic bk.)
Media category
computer
Media MARC source
rdamedia
Media type code
c
Reproduction note
Electronic reproduction.
Specific material designation
remote
System control number
(NhCcYBP)ebr10358922
Label
A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim, Margaret B. Liu and Kate Davis, (electronic resource)
Link
http://site.ebrary.com/lib/umanitoba/docDetail.action?docID=10358922
Publication
Note
  • Description based on print version record
  • Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Postmarketing Surveillance of Drugs, Biologics, and Devices.
  • 3 Good Clinical Practice and the Regulations.
  • Good Clinical Practice.
  • Responsibilities in the Code of Federal Regulations.
  • Where to Obtain Information and Guidance for the Regulations and GCP.
  • 4 Informed Consent and the Regulations.
  • What Is Informed Consent?
  • Ethical Codes Regarding Informed Consent.
  • Regulatory Requirements for Informed Consent.
  • Informed Consent Process.
  • Machine generated contents note:
  • 5 Institutional Review Boards.
  • What is an Institutional Review Board?
  • IRB Activities.
  • Types of IRB Review.
  • Communication between IRBs and Investigators.
  • Communication between IRBs and Study Sponsors.
  • IRB Records and Reports.
  • Accreditation of IRBs.
  • Registration.
  • 6 Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others.
  • Foreword (Robert A. Harrington).
  • Why Collect Adverse Event Data?
  • Adverse Events.
  • Unanticipated Problems Involving Risks to Subjects or Others.
  • Investigator Responsibilities.
  • IRB Responsibilities.
  • Sponsor Responsibilities.
  • 7 Monitoring, Audits, and Inspections.
  • Monitoring Plan.
  • On-Site Monitoring.
  • In-House Monitoring.
  • Preface.
  • Audits and Inspections.
  • 8 The Principal Investigator, the Clinical Research Coordinator, and the Study Site.
  • Principal Investigator.
  • Staffing to Support Clinical Trials.
  • Space and Resource Needs.
  • Local Institutional Review Board.
  • 9 The Protocol.
  • Common Components of a Protocol.
  • Background and Rationale.
  • Study Organization.
  • List of Abbreviations.
  • Objectives/Endpoints.
  • Study Design.
  • Study Population.
  • Study Treatment Plan.
  • Safety Assessment, Management, and Reporting.
  • Replacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects.
  • Statistical Aspects.
  • Subject Data and Record Retention.
  • Monitoring.
  • 10 Study Feasibility: Reviewing a Specific Protocol.
  • 1 Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research.
  • Reviewing a Specific Protocol.
  • Should We Do this Study at Our Site?
  • 11 Study Activities.
  • Study Start-up Phase.
  • Study Maintenance Phase.
  • Study Completion and Close-Out Phase.
  • 12 Study Documents/Essential Documents.
  • Documents at Study Start-Up.
  • Documents While the Study is in Progress.
  • Documents at Study Close-out.
  • 2 The Process: Developing New Drugs, Biologics, and Devices.
  • Maintaining Your Site Study File.
  • 13 Management of Study Drugs, Biologics, and Devices.
  • Study Drugs and Biologics.
  • Study Devices.
  • 14 Managing Clinical Trial Data.
  • HIPAA, the Privacy Rule, and Clinical Trial Data.
  • Guidelines and Regulations Regarding Clinical Trial Data.
  • Study Site Responsibilities Regarding Clinical Trial Data.
  • Source Document Verification of Clinical Trial Data.
  • Release of Protected Medical Information.
  • Drug Development Process.
  • Confidentiality of Clinical Trial Data.
  • Endpoint Adjudication.
  • 15 Global Health and International Trials.
  • International Clinical Trials.
  • Ethnic and Racial Differences.
  • Ethical Issues and Cultural Sensitivities.
  • Why International Trials Are Important.
  • International Regulations.
  • Concerns.
  • Future Efforts.
  • Developing New Devices.
  • Appendices.
  • Epilogue (Lisa G. Berdan).
  • Glossary
Dimensions
unknown
Edition
2nd ed.
Extent
1 online resource.
Form of item
online
Isbn
9781444315226
Isbn Type
(electronic bk.)
Media category
computer
Media MARC source
rdamedia
Media type code
c
Reproduction note
Electronic reproduction.
Specific material designation
remote
System control number
(NhCcYBP)ebr10358922

Library Locations

  • Albert D. Cohen Management LibraryBorrow it
    181 Freedman Crescent, Winnipeg, MB, R3T 5V4, CA
    49.807878 -97.129961
  • Architecture/Fine Arts LibraryBorrow it
    84 Curry Place, Winnipeg, MB, CA
    49.807716 -97.136226
  • Archives and Special CollectionsBorrow it
    25 Chancellors Circle (Elizabeth Dafoe Library), Room 330, Winnipeg, MB, R3T 2N2, CA
    49.809961 -97.131878
  • Bibliothèque Alfred-Monnin (Université de Saint-Boniface)Borrow it
    200, avenue de la Cathédrale, Local 2110, Winnipeg, MB, R2H 0H7, CA
    49.888861 -97.119735
  • Bill Larson Library (Grace Hospital)Borrow it
    300 Booth Drive, G-227, Winnipeg, MB, R3J 3M7, CA
    49.882400 -97.276436
  • Carolyn Sifton - Helene Fuld Library (St. Boniface General Hospital)Borrow it
    409 Tache Avenue, Winnipeg, MB, R2H 2A6, CA
    49.883388 -97.126050
  • Concordia Hospital LibraryBorrow it
    1095 Concordia Avenue, Winnipeg, MB, R2K 3S8, CA
    49.913252 -97.064683
  • Donald W. Craik Engineering LibraryBorrow it
    75B Chancellors Circle (Engineering Building E3), Room 361, Winnipeg, MB, R3T 2N2, CA
    49.809053 -97.133292
  • E.K. Williams Law LibraryBorrow it
    224 Dysart Road, Winnipeg, MB, R3T 5V4, CA
    49.811829 -97.131017
  • Eckhardt-Gramatté Music LibraryBorrow it
    136 Dafoe Road (Taché Arts Complex), Room 257, Winnipeg, MB, R3T 2N2, CA
    49.807964 -97.132222
  • Elizabeth Dafoe LibraryBorrow it
    25 Chancellors Circle, Winnipeg, MB, R3T 2N2, CA
    49.809961 -97.131878
  • Fr. H. Drake Library (St. Paul's College)Borrow it
    70 Dysart Road, Winnipeg, MB, R3T 2M6, CA
    49.810605 -97.138184
  • J.W. Crane Memorial Library (Deer Lodge Centre)Borrow it
    2109 Portage Avenue, Winnipeg, MB, R3J 0L3, CA
    49.878000 -97.235520
  • Libraries Annex (not open to the public; please see web page for details)Borrow it
    25 Chancellors Circle (in the Elizabeth Dafoe Library), Winnipeg, MB, R3T 2N2, CA
    49.809961 -97.131878
  • Neil John Maclean Health Sciences LibraryBorrow it
    727 McDermot Avenue (Brodie Centre), 200 Level, Winnipeg, MB, R3E 3P5, CA
    49.903563 -97.160554
  • Sciences and Technology LibraryBorrow it
    186 Dysart Road, Winnipeg, MB, R3T 2M8, CA
    49.811526 -97.133257
  • Seven Oaks General Hospital LibraryBorrow it
    2300 McPhillips Street, Winnipeg, MB, R2V 3M3, CA
    49.955177 -97.148865
  • Sister St. Odilon Library (Misericordia Health Centre)Borrow it
    99 Cornish Avenue, Winnipeg, MB, R3C 1A2, CA
    49.879592 -97.160425
  • St. John's College LibraryBorrow it
    92 Dysart Road, Winnipeg, MB, R3T 2M5, CA
    49.811242 -97.137156
  • Victoria General Hospital LibraryBorrow it
    2340 Pembina Highway, Winnipeg, MB, R3T 2E8, CA
    49.806755 -97.152739
  • William R Newman Library (Agriculture)Borrow it
    66 Dafoe Road, Winnipeg, MB, R3T 2R3, CA
    49.806936 -97.135525
Processing Feedback ...