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 apply them in clinical trials and organizing a clinical practice.

New chapters, updated content, more tips, helpful exercises and more! 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

This book is divided into 25 chapters covering more than 300 topics. This book will serve as a training guide to make your routine tasks more efficient, compliant and easy. After reading this book, Clinical Research Coordinators, clinical research personnel and aspirants would get: # Step by step in-depth training on roles and responsibilities of a clinical research coordinator before, during and after the completion of a clinical trial. # Discussion on day-to-day challenges and their solutions. # Training through real-time examples and ready-made checklists to conduct each activity more efficiently and correctly. # Guidance through strategies and measures to execute critical clinical trial activities. # Training on regulatory and ICH-GCP guidelines. # Tips on effective communication and coordination with site staff, investigator, sponsor, and IRB. # Assistance to become a better and successful clinical research coordinator. # Knowledge on other essential topics of clinical research.

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Since 1995, more than 150,000 students and researchers have turned to The Craft of Research for clear and helpful guidance on how to conduct research and report it effectively . Now, master teachers Wayne C. Booth, Gregory G. Colomb, and Joseph M. Williams present a completely revised and updated version of their classic handbook. Like its predecessor, this new edition reflects the way researchers actually work: in a complex circuit of thinking, writing, revising, and rethinking. It shows how each part of this process influences the others and how a successful research report is an orchestrated conversation between a researcher and a reader. Along with many other topics, The Craft of Research explains how to build an argument that motivates readers to accept a claim; how to anticipate the reservations of thoughtful yet critical readers and to respond to them appropriately; and how to create introductions and conclusions that answer that most demanding question, "So what?" Celebrated by reviewers for its logic and clarity, this popular book retains its five-part structure. Part 1 provides an orientation to the research process and begins the discussion of what motivates researchers and their readers. Part 2 focuses on finding a topic, planning the project, and locating appropriate sources. This section is brought up to date with new information on the role of the Internet in research, including how to find and evaluate sources, avoid their misuse, and test their reliability. Part 3 explains the art of making an argument and supporting it. The authors have extensively revised this section to present the structure of an argument in clearer and more accessible terms than in the first edition. New distinctions are made among reasons, evidence, and reports of evidence. The concepts of qualifications and rebuttals are recast as acknowledgment and response. Part 4 covers drafting and revising, and offers new information on the visual representation of data. Part 5 concludes the book with an updated discussion of the ethics of research, as well as an expanded bibliography that includes many electronic sources. The new edition retains the accessibility, insights, and directness that have made The Craft of Research an indispensable guide for anyone doing research, from students in high school through advanced graduate study to businesspeople and government employees. The authors demonstrate convincingly that researching and reporting skills can be learned and used by all who undertake research projects. New to this edition: Extensive coverage of how to do research on the internet, including how to evaluate and test the reliability of sources New information on the visual representation of data Expanded bibliography with many electronic sources

Designated a Doody's Core Title! "This is a valuable resource for readers seeking basic to advanced information on measurement. It should be on the bookshelf of all researchers, and a requirement for graduate nursing students."Score: 100, 5 stars--Doody's Medical Reviews "...this book is a wonderful shelf reference for nurse researcher mentors and investigators who may need to explore content or use content to design, test, select, and evaluate instruments and methods used in measuring nurse concepts and outcomes."--Clinical Nurse Specialist This fourth edition presents everything nurses and health researchers need to know about designing, testing, selecting, and evaluating instruments and methods for measuring in nursing. Thoroughly updated, this fourth edition now contains only the latest, most cutting-edge measurement instruments that have direct applicability for nurses and health researchers in a variety of roles, including students, clinicians, educators, researchers, administrators, and consultants. Using clear and accessible language, the authors explain in detail, and illustrate by example, how to conduct sound measurement practices that have been adequately tested for reliability and validity. This edition is enriched with topics on the leading edge of nursing and health care research, such as measurement in the digital world, biomedical instrumentation, new clinical data collection methods, and methods for measuring quality of care. Key features: Provides new and emerging strategies for testing the validity of specific measures Discusses computer-based testing: the use of Internet research and data collection Investigates methods for measuring physiological variables using biomedical instrumentation Includes information on measurement practices in clinical research, focusing on clinical data collection methods, such as clinimetrics Identifies the challenges of measuring quality of care and how to address them

This guidebook will show how supervisors can ensure support staff to deliver quality services for people with disabilities whose quality of life is heavily dependent on how well those services are provided. Supervisors must ensure staff receive necessary training in their job duties, are actively supported to stay motivated to work proficiently and, at times, effectively assisted to improve their work performance. Supervisors have to overcome many challenges to fulfill these critical duties, often involving frequent changes in their staff work force and varying or limited resources. Complicating the job of staff supervisors is a lack of formal training necessary to perform their supervisory duties effectively. When supervisors do receive training in how to supervise staff work performance, the training is not always very useful. The training is frequently too general to equip supervisors with knowledge and skills to affect staff work performance on a routine basis. The training also is commonly based on unproven means of promoting quality staff performance, stemming from current fads or ideology that has little if any hard evidence to support the training content. Over the last five decades, a technology for supervising staff work performance in the human services has been evolving, derived from applied research conducted in many human service agencies. However, most supervisors have not had opportunities to become aware of these evidence-based means of fulfilling their supervisory duties. The purpose of The Supervisor’s Guidebook is to describe the existing evidence-based approach to supervision. Description of the approach is supplemented with practical suggestions based on the authors’ combined experience encompassing over 100 years of supervising staff performance in the human services. The intent is to provide supervisors with detailed information about tried and tested means of promoting diligent and proficient staff performance and to do so in a way that maximizes staff enjoyment with their work.