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Developing a Successful Clinical Research Program (2018 Edition) Paperback
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物品細節
- 物品狀況
- Title
- Developing a Successful Clinical Research Program
- Topic
- Economic Strategy, Finance, Health, Industry, Management, Management Techniques, Marketing, Medical Services, Medicine, Money, Negotiating, Network, Networking, Recruitment Tests, Relationships, Setting up Business, Success, Time Management, Becoming a Clinical Research Team
- Subjects
- Health, Treatments & Medicine
- ISBN
- 9783319546926
關於產品
Product Identifiers
Publisher
Springer International Publishing A&G
ISBN-10
3319546929
ISBN-13
9783319546926
eBay Product ID (ePID)
240236921
Product Key Features
Number of Pages
Xix, 270 Pages
Language
English
Publication Name
Becoming a Clinical Research Team : How to Start, Continually Improve and Excel
Subject
Clinical Medicine, General
Publication Year
2018
Type
Textbook
Subject Area
Medical
Format
Trade Paperback
Dimensions
Item Weight
18.2 Oz
Item Length
8 in
Item Width
5 in
Additional Product Features
Reviews
'"Developing a Successful Clinical Research Program' is a compact but comprehensive primer for the new investigator or clinical research site. The book includes practical, clearly written material, such as the beginning of the chapter on starting a clinical research team." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 15 (2), February, 2019)
Number of Volumes
1 vol.
Illustrated
Yes
Table Of Content
Why Do Clinical Research?- How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect.- Choosing Studies.- Starting Clinical Research.- Developing a Budget.- Negotiating a Contract.- Writing a Great Informed Consent (IC).- Starting the Study.- Regulatory Startup.- Recruiting.- Getting Subjects through the Door.- The Screening Visit.- Follow-up Visits.- Maintaining Subject Retention and Avoiding Study Fatigue.- Adverse Events (AE's) and Protocol Deviations.- Contact Research Organizations (CRO's) and Monitors.- Annual Review and Financial Disclosures.- Finishing a Study.- Staff Training and Incentives.- Study Closeout.- Acing an Audit.- Expanding the Team.- Epilogue: Watching Medicine Evolve.- Appendices.
Synopsis
This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal ofthis book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting., This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.
LC Classification Number
R1
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