How to Conduct successful clinical trials: a step-by-step approach and quick reference. An excellent resource for physicians and professionals who want to break into the exciting world of clinical reserach.

The Investigator's Guide to Clinical Research (Second Edition)

Science & Math

Ginsberg, Dr. David

Research

CenterWatch

The CRC's Guide to Coordinating Clinical Research, 4th edition, is the most comprehensive, easy-to-read training guide for novice and experienced clinical research coordinators. The newly-released fourth edition includes industry facts, insights on the role and responsibilities, personal experiences to learn from, checklists to help you be successful and efficient as a CRC, key takeaways, case studies and much more on this important role in the clinical research industry. 
 The CRC Guide is the ideal go-to resource for professionals interested in pursuing a clinical research coordinator position as well as an easy-to-reference training guide for experienced CRCs, on-site professional development courses and professors teaching courses in this field.

The CRC's Guide to Coordinating Clinical Research, Fourth Edition

Medical Books

Sandra Sather

Nursing

Product Description As the clinical research enterprise continues to evolve at a rapid pace, the physician investigator is charged with meeting the demands of conducting faster clinical trials, adhering to stricter requirements from sponsors and regulatory bodies and managing increased competition in the market all while maintaining the highest quality and patient safety standards. The PI s Guide to Conducting Clinical Research, first published in 1997 and previously titled Becoming a Successful Clinical Research Investigator, is the only industry resource designed to assist both novice and experienced PIs in meeting these higher, more challenging expectations to conduct better, safer and more efficient clinical trials. Investigators will learn to: -Understand investigator responsibilities from practical and ethical study conduct to site and financial management -Secure new clinical studies, assess feasibility and create study budgets Comply with changing federal regulatory guidelines -Practice ICH-GCP guidelines Implement and adhere to strict standard operating procedures -Recruit and retain study volunteers Understand informed consent and human subject protection -Prepare for sponsor or IRB audits -Prepare for certification exams and more Recommended for: -Physician investigators, sub-investigators and clinical research scientists interested in or already conducting clinical trials for pharmaceutical or biotech companies -Instructors conducting clinical research training and educational programs -Professors or researchers developing college curriculums -Sponsors, CROs, SMOs and academic institutions interested in providing a reference manual for their investigators About the Author Elizabeth Weeks-Rowe, LVN, CCRA, has spent over 18 years in a variety of clinical research roles including study coordinator, CRA, CRA trainer, CRA manager and clinical research writer. She has developed training content and presented clinical research topics for leading industry training and education organizations. She has created marketing content, website content and clinical operations newsletters for European and U.S.-based clinical research organizations. She is a contributing writer for several leading industry publications, including a recurring clinical research column for a leading clinical research news publication. She has authored a white paper on best industry practices for co-monitoring assessments, and unblinded pharmacy monitoring/ monitoring practice. She is the author of a clinical research novella entitled, Clinical Research Trials and Triumphs; a heart warming novel following a nurse s journey into clinical research. She is an instructor for a well known clinical research training company and speaks at global industry clinical research meetings. For the last 7 years, she has worked in a critical site selection and training role for a leading CRO.

The PI's Guide to Conducting Clinical Research, Second Edition

Elizabeth Weeks-Rowe

Protecting Study Volunteers in Research: A Manual for Investigative Sites

Chadwick, Gary L.

The CRA's Guide to Monitoring Clinical Research is a valuable and practical educational resource for the individual readers and for group and staff training programs. Written by Karen E. Woodin, Ph.D., and John C. Schneider, this 400+ page CE-accredited book is an ideal resource for novice and experienced CRAs, as well as professionals interested in pursuing a career as study monitors. 
The CRA's Guide explains the role and responsibilities of a CRA, informs readers of the history of the regulations, explains in detail the research process and describes the regulations and GCPs that govern clinical research. 
Book topics: 
- Preparing for a study and selecting investigators - Obtaining and monitoring informed consent - Preparing for a monitoring visit - Recruiting and retaining study subjects - Conducting adverse event and safety monitoring - Preparing for audits and detecting fraud

The CRA's Guide to Monitoring Clinical Research

Schneider, John C.

Woodin, Karen E., Ph.D.

This well-organized and concise manual teaches organizations how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are critical to our system of human subject protection oversight. Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002) and has become required reading in many academic institutions, IRBs, investigative sites, and for many Biopharmaceutical and CRO companies. Written by Cynthia Dunn, M.D. of Western Institutional Review Board and Gary Chadwick, Pharm.D., M.P.H. of the University of Rochester, this manual has been developed in accordance with ACCME. Readers can apply for CME credits or nursing contact hours. An exam is provided with each manual and is also available online. Topics covered include: *Conflicts of interest in research *Participant recruitment and retention in clinical trials *Research with secondary subjects, tissue studies, and records review *Historical perspectives on human subject research *Updated ethics and federal regulations *Roles and responsibilities of institutions and independent sites *Roles and responsibilities of investigators and the study process

McGuire-Dunn, Cynthia, M.D.

The CRC's Guide to Coordinating Clinical Research has been one of the foremost training tools and reference guides for novice and experienced coordinators since the first edition was released in 2004. Now with new chapters on investigational product accountability, device and biologics trials and data safety monitoring boards, along with key takeaways and newly added case studies, The CRC's Guide is the most comprehensive resource available for on-site training staffs, professors or individuals interested in a step-by-step approach to coordinating successful clinical trials. Topics include: -A comprehensive review of CRC roles and responsibilities -Understanding regulations and GCPs -Preparing for a study -Working with study subjects -The informed consent process -Case report forms and EDC -Study closure -The future outlook -Job descriptions and current academic programs -Adverse Events and Safety Monitoring -Sample Forms, Checklists and Logs Recommended for: -Novice and experienced CRCs -Health professionals interested in pursuing a career as a study coordinator -Instructors conducting training and educational programs

The CRC's Guide to Coordinating Clinical Research, Second Edition

Karen E. Woodin

PH.D.

CenterWatch introduces the most concise, yet comprehensive resource available on the major global regulatory systems including the most relevant and pertinent regulatory facts and guidelines consolidated into one, must-have and easy-to-read resource. This strategic road map takes the reader through a dynamic and complex landscape while providing a fundamental understanding and application of global regulatory principles to ensure successful product development and registration.

Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration

Dr. Henrietta Ukwu

As the clinical research enterprise continues to evolve at a rapid pace, the physician investigator is charged with meeting the demands of conducting faster clinical trials, adhering to stricter requirements from sponsors and regulatory bodies and managing increased competition in the market all while maintaining the highest quality and patient safety standards. The PI s Guide to Conducting Clinical Research, first published in 1997 and previously titled Becoming a Successful Clinical Research Investigator, is the only industry resource designed to assist both novice and experienced PIs in meeting these higher, more challenging expectations to conduct better, safer and more efficient clinical trials. Investigators will learn to: -Understand investigator responsibilities from practical and ethical study conduct to site and financial management -Secure new clinical studies, assess feasibility and create study budgets Comply with changing federal regulatory guidelines -Practice ICH-GCP guidelines Implement and adhere to strict standard operating procedures -Recruit and retain study volunteers Understand informed consent and human subject protection -Prepare for sponsor or IRB audits -Prepare for certification exams and more Recommended for: -Physician investigators, sub-investigators and clinical research scientists interested in or already conducting clinical trials for pharmaceutical or biotech companies -Instructors conducting clinical research training and educational programs -Professors or researchers developing college curriculums -Sponsors, CROs, SMOs and academic institutions interested in providing a reference manual for their investigators

The PI's Guide to Conducting Clinical Research

Editor)

Cheryl Rosenfeld

The CRA's Guide to Monitoring Clinical Research, fourth edition, continues to be a vital resource for both novice and experienced CRAs seeking to learn more about the field of monitoring or to better understand their roles and responsibilities as the industry becomes more global and technologically focused. This edition includes helpful tips and strategies, checklists, personal experiences, traveling tips, key takeaways and exercises. With new and updated chapters on the evolving CRA roles and responsibilities, monitoring for device and biologic trials, risk-based monitoring, globalization of studies, EMR, web-driven data collection, the sub-PI role, and more, The CRA's Guide is a must-have training and educational tool that you'll refer to time and time again.

The CRA's Guide to Monitoring Clinical Research, Fourth Edition

Karen E. Woodin Ph.D.

John C. Schneider

See the best price to sell, buy or rent books by the CenterWatch publisher. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by CenterWatch

See the best price to sell, buy or rent books by the CenterWatch publisher. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

The Investigator's Guide to Clinical Research (Second Edition)

The CRC's Guide to Coordinating Clinical Research, Fourth Edition

The PI's Guide to Conducting Clinical Research, Second Edition

Protecting Study Volunteers in Research: A Manual for Investigative Sites

The CRA's Guide to Monitoring Clinical Research

Protecting Study Volunteers in Research: A Manual for Investigative Sites

The CRC's Guide to Coordinating Clinical Research, Second Edition

Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration

The PI's Guide to Conducting Clinical Research

The CRA's Guide to Monitoring Clinical Research, Fourth Edition