Clinical research : from proposal to implementation / [edited by] Michael J. McPhaul, Robert D. Toto ; research ethics commentaries by Simon J. Craddock Lee and John Z. Sadler.

Format:

Book

Contributor:

McPhaul, Michael J.

Toto, Robert D.

Language:

English

Subjects (All):

Clinical trials.

Biomedical Research--methods.

Clinical Trials as Topic--methods.

Research Design.

Medical Subjects:

Biomedical Research--methods.

Clinical Trials as Topic--methods.

Research Design.

Physical Description:

xiii, 255 pages : illustrations ; 23 cm

Place of Publication:

Philadelphia : Wolters Kluwer/Lippincott Williams & Wilkins Health, [2011]

Summary:

"Clinical and translational research is a crucial link to the improvement of clinical care and practice. Many of the elements that are involved--physicians, nurses, pharmacists, laboratory testing, medical records--are also involved in the delivery of care to patients. Yet in the conduct of clinical research, these elements are arrayed in different configurations and constrained by rules and regulations that are distinct from those that guide the practice of medicine. In parallel with these considerations, the conduct of clinical research demands a specific skill set. Specialized tools are required to formulate and design informative clinical trials and to interpret the findings from such experiments"--Provided by publisher.

Contents:

Chapter 1. How to launch a successful career in clinical research: Tips on making the most of available resources / Robert D. Toto

Chapter 2. Institutional Review Board Approval / Suzanne M. Rivera

Chapter 3. Writing Informed Consent Documents and Obtaining Informed Consent / Anne Clark, Suzanne M. Rivera, Diane Sheppard, Darren K. McGuire, and Michael J. McPhaul

Chapter 4. Ethics of Data Sharing and Handling of Genetic Information / Bradley Malin, David Karp and Richard H. Scheuermann

Chapter 5. Writing a Statistical Analysis Plan / Beverley Adams-Huet and Chul Ahn

Chapter 6. Protocol Implementation Procedures / Tammy L. Lightfoot

Chapter 7. Screening and Evaluation / Robert D. Toto

Chapter 8. Recruitment and Retention / Tammy L. Lightfoot

Chapter 9. How to Set Up Your Database / Janet P. Smith

Chapter 10. Budgeting Process and Management / Deanna S. Adams

Chapter 11. Understanding Food and Drug Administration (FDA) regulatory requirements for investigational new drug applications (IND) for sponsor-investigators / M.E. Blair Holbein

Chapter 12. Collecting Data / Deanna S. Adams

Chapter 13. Data and Safety Monitoring / Andrea M. Nassen

Chapter 14. Presenting, Writing, and Publishing Challenges / Charles T. Quinn and A. John Rush.

Notes:

Includes bibliographical references and index.

ISBN:

9781605477480

1605477486

OCLC:

632070488