The Sourcebook for Clinical Research
  • Author : Natasha Martien
  • Release Date : 15 August 2018
  • Publisher : Academic Press
  • Genre : Medical
  • Pages : 256
  • ISBN 13 : 0128162422

The Sourcebook for Clinical Research Book Summary

A clinical trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines, and specific protocol instructions to follow. The Sourcebook for Clinical Trials provides a comprehensive overview of the clinical trial process covering the basics to more advances topics. The book discusses foundational elements defining clinical trials and types of research studies, research personnel and responsibilities, and understanding the role of HIPAA and PHI. The book also covers pre-trial preparation and regulatory requirements, subject recruitment, mechanics and trial conduct, review boards and agencies involved in the clinical trial process as well as post-trial study closeout. The inclusion of helpful resources, sample forms, and checklists make The Sourcebook for Clinical Trials an essential step-by-step resource for those involved in conducting, managing, or overseeing clinical trials. Offers guidance that is crucial for guaranteeing compliance to clinical trial protocols during each stage of the clinical trial process Lays out vital information in an easy, accessible format to keep investigative teams current on federal regulations and good clinical practice Provides up-to-date and extensive coverage of Federal and IRB regulations and helpful worksheets, templates, checklists, and protocol resources for clinical trial personnel to utilize

The Sourcebook for Clinical Research

The Sourcebook for Clinical Research

Author : Natasha Martien,Jeff Nelligan
Publisher : Academic Press
Genre : Medical
Total View : 3282 Views
File Size : 46,7 Mb
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A clinical trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines, and specific protocol instructions to follow. The Sourcebook for Clinical Trials provides a comprehensive overview of the clinical trial process covering the basics to more advances topics. The book discusses foundational elements defining clinical trials and types ...

The Sourcebook for Clinical Research

The Sourcebook for Clinical Research

Author : Natasha Martien,Jeff Nelligan
Publisher : Academic Press
Genre : Medical
Total View : 9184 Views
File Size : 51,8 Mb
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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference ...

Clinical Trials and Human Research

Clinical Trials and Human Research

Author : Fay A. Rozovsky, JD, MPH,Rodney K. Adams
Publisher : Jossey-Bass
Genre : Medical
Total View : 6439 Views
File Size : 40,5 Mb
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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies ...

The Fundamentals of Clinical Research

The Fundamentals of Clinical Research

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Genre : Medical
Total View : 8160 Views
File Size : 49,5 Mb
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This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. ...

The CRC s Guide to Coordinating Clinical Research

The CRC s Guide to Coordinating Clinical Research

Author : Karen E. Woodin
Publisher : Centerwatch Incorporated
Genre : Medical
Total View : 8542 Views
File Size : 44,8 Mb
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This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to ...

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Genre : Mathematics
Total View : 8678 Views
File Size : 42,8 Mb
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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to ...