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Clinical investigation of medical devices for human subjects : good clinical practice

https://libcat.nshealth.ca/en/permalink/provcat34842
International Organization for Standardization. (Second edition) --Geneva, Switzerland: ISO , 2011.
Call Number
W 20.5 I61c 2011 c.2
Location
Dickson Building
Call Number
W 20.5 I61c 2011 c.2
Corporate Author
International Organization for Standardization
Edition
Second edition
Alternate Title
ISO 14155
Place of Publication
Geneva, Switzerland
Publisher
ISO
Date of Publication
2011
Physical Description
v, 58 pages
Subjects (MeSH)
Equipment Safety - standards
Technology Assessment, Biomedical - standards
Clinical Trials as Topic - standards
Ethics, Clinical
Notes
"International standard".
Reference number ISO 14155:2011(E)
Format
Book
Location
Dickson Building
Copies
2
Loan Period
3 weeks
Less detail

Clinical trials and human research : a practical guide to regulatory compliance

https://libcat.nshealth.ca/en/permalink/provcat22768
Rozovsky, Fay A. --San Francisco, CA: Jossey-Bass , 2003.
Call Number
W 32.5 R893c 2003
Location
Dickson Building
Call Number
W 32.5 R893c 2003
Author
Rozovsky, Fay A.
Other Authors
Adams, Rodney K.
Place of Publication
San Francisco, CA
Publisher
Jossey-Bass
Date of Publication
2003
Physical Description
639 p.
ISBN
0787965707
Subjects (MeSH)
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - standards
Ethics Committees, Research
Ethics, Research
Human Experimentation - legislation & jurisprudence
Human Experimentation - standards
Other Subjects
United States
Format
Book
Location
Dickson Building
Loan Period
3 weeks
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The CRA's guide to monitoring clinical research

https://libcat.nshealth.ca/en/permalink/provcat22643
Woodin, Karen E. --Boston, MA: Thomson CenterWatch , 2003.
Call Number
W 20.5 W891c 2003
Location
Halifax Infirmary
Dickson Building
Call Number
W 20.5 W891c 2003
Author
Woodin, Karen E.
Other Authors
Schneider, John C.
Place of Publication
Boston, MA
Publisher
Thomson CenterWatch
Date of Publication
2003
Physical Description
448 p.
ISBN
1930624379
Subjects (MeSH)
Clinical Trials as Topic - standards
Clinical Trials Data Monitoring Committees
Drug Approval - organization & administration
Ethics, Research
Guideline Adherence
Research Design
Research Support as Topic - organization & administration
Format
Book
Location
Halifax Infirmary
Dickson Building
Copies
2
Loan Period
3 weeks
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The CRC's guide to coordinating clinical research

https://libcat.nshealth.ca/en/permalink/provcat22642
Woodin, Karen E. --Boston, MA: Thomson CenterWatch , 2004.
Call Number
W 20.5 W891c 2004
Location
Halifax Infirmary
Dickson Building
Call Number
W 20.5 W891c 2004
Author
Woodin, Karen E.
Place of Publication
Boston, MA
Publisher
Thomson CenterWatch
Date of Publication
2004
Physical Description
411 p.
ISBN
1930624468
Subjects (MeSH)
Biomedical Research - organization & administration
Clinical Trials as Topic - legislation & jurisprudence
Clinical Trials as Topic - standards
Drug Approval - organization & administration
Ethics, Research
Guideline Adherence
Research Design
Other Subjects
United States
Format
Book
Location
Halifax Infirmary
Dickson Building
Copies
2
Loan Period
3 weeks
Less detail

Good clinical practice : a question and answer reference guide

https://libcat.nshealth.ca/en/permalink/provcat22968
edited by Mark P. Mathieu. --Media, PA: Barnett International , c2006.
Call Number
W 20.5 G646 2006
Location
Dickson Building
Call Number
W 20.5 G646 2006
Author
Mathieu, Mark P.
Responsibility
edited by Mark P. Mathieu
Place of Publication
Media, PA
Publisher
Barnett International
Date of Publication
c2006
Physical Description
586 p.
ISBN
1882615786
Subjects (MeSH)
Biomedical Research - standards
Clinical Trials as Topic - standards
Guideline Adherence - organization & administration
Notes
"May 2006".
Format
Book
Publication Type
Handbook
Practice Guideline
Location
Dickson Building
Loan Period
3 weeks
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Good practice of clinical drug trials

https://libcat.nshealth.ca/en/permalink/provcat22769
Spriet, Alain. (3rd ed., rev. and expanded) --Basel, Switzerland: Karger , 2005.
Call Number
QV 771 G646 2005
Location
Dickson Building
Call Number
QV 771 G646 2005
Author
Spriet, Alain
Other Authors
Dupin-Spriet, Thérèse
Edition
3rd ed., rev. and expanded
Place of Publication
Basel, Switzerland
Publisher
Karger
Date of Publication
2005
Physical Description
273 p.
ISBN
3805577249
Subjects (MeSH)
Clinical Trials as Topic - standards
Drug Evaluation - standards
Contents
Clinical trials and quality -- Bad clinical practices -- Standards of good clinical practices -- Protection of participants -- Writing the investigator's brochure -- Writing the protocol -- Designing the case report forms -- Monitoring a clinical trial -- Data management -- Computerized data processing and security -- Statistical analysis -- Using the investigational medicinal product -- Clinical laboratory data -- Adverse events -- Clinical study report -- Filing and archiving -- Audit of a clinical trial -- Systems audit -- Outsourcing -- Crisis management -- Preparation for inspection -- Management of suspected fraud.
Format
Book
Location
Dickson Building
Loan Period
3 weeks
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A guide to good clinical practice

https://libcat.nshealth.ca/en/permalink/provcat22764
Kanarek, Alex D. (2nd ed.) --Westborough, MA: D&MD Publications , 2005.
Call Number
W 20.55 .H9 K16g 2005
Location
Dickson Building
Call Number
W 20.55 .H9 K16g 2005
Author
Kanarek, Alex D.
Edition
2nd ed.
Place of Publication
Westborough, MA
Publisher
D&MD Publications
Date of Publication
2005
Physical Description
212 p.
Series
Guide #9192 ; August 2005
ISBN
1579363377
Subjects (MeSH)
Biomedical Research - standards
Clinical Trials as Topic - standards
Guideline Adherence - organization & administration
Format
Book
Publication Type
Practice Guideline
Location
Dickson Building
Loan Period
3 weeks
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Quick Guide to Good Clinical Practice : How to Meet International Quality Standard in Clinical Research

https://libcat.nshealth.ca/en/permalink/provcat41519
Cemal Cingi, Nuray Bayar Muluk. --Cham: Springer , 2017.
Available Online
View e-Book
Location
Online
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard, Good Clinical Practice, provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC reg…
Available Online
View e-Book
Author
Cingi, Cemal
Other Authors
Bayar Muluk, Nuray
Responsibility
Cemal Cingi, Nuray Bayar Muluk
Place of Publication
Cham
Publisher
Springer
Date of Publication
2017
Physical Description
1 online resource (xviii, 237 pages)
ISBN
9783319443447
9783319443430 (print ed.)
Subjects (MeSH)
Biomedical Research - standards
Clinical Trials as Topic - standards
Data Accuracy
Ethics, Research
Internationality
Total Quality Management - standards
Specialty
Research
Abstract
This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard, Good Clinical Practice, provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.
Contents
1. Clinical Trials: Historical Aspects and Importance and New Drug Developments -- 2. The Definition of GCP -- 3. The Principles of GCP -- 4. The Drug Development Process and Evolution of Regulations -- 5. Planning Clinical Research -- 6. Preparation of Ethics Committee (IRB) Proposal -- 7. Preparation of Informed Consent -- 8. Preparation of Findings Tables -- 9. Setting the Ideal Statistical Methods -- 10. The Duties of a Clinical Research Coordinator -- 11. The Duties of Clinical Researchers -- 12. The Phases of Clinical Studies -- 13. Safety in Clinical Trials -- 14. Setting the Size -- 15. Setting the Ideal Method -- 16. Ethics of Clinical Research -- 17. Recruitment and Enrolment -- 18. Why we need Clinical Consent and Other Documentation -- 19. Monitoring the Trial -- 20. Inspection -- 21. Ethics: Institutional Review Board/Independent Ethics Committee(IRB/IEC) -- 22. Responsibilities of the Investigator -- 23. Responsibilities of the Sponsor -- 24. Clinical Trial Protocols.
Format
e-Book
Location
Online
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Selected documents on conducting clinical research in Canada

https://libcat.nshealth.ca/en/permalink/provcat22941
--Philadelphia, PA: Clinical Research Resources , 2006.
Call Number
W 20.5 S464 2006
Location
Dickson Building
Call Number
W 20.5 S464 2006
Alternate Title
Clinical research in Canada
Place of Publication
Philadelphia, PA
Publisher
Clinical Research Resources
Date of Publication
2006
Physical Description
1 v. (various pagings)
Subjects (MeSH)
Biomedical Research - standards
Clinical Trials as Topic - standards
Other Subjects
Canada
Contents
ICH Guideline (Step 5, Canada). Good Clinical Pactice: Consolidated Guidance (ICH-E6) -- ICH Guideline (Step 5, Canada). Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A) -- ICH Guideline (Step 5, Canada). Guidance on General Considerations for Clinical Trials (ICH-E8) -- Health Canada. Division 5 Regulations and Extract from Regulatory Impact Analysis Statement -- Extract from Tri-Council Policy Statement: Ethical Conduct for Research Involving Humanss, 1998 (with 2000, 2002 updates) -- World Medical Association. Declaration of Helsinki -- The Belmont Report.
Format
Book
Publication Type
Practice Guideline
Location
Dickson Building
Copies
2
Loan Period
3 weeks
Less detail

9 records – page 1 of 1.