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There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.
* Provides a practical overview of data monitoring in clinical trials.
* Describes the purpose, responsibilities and operation of data monitoring committees.
* Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
* Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
* Discusses issues pertinent to those working in clinical trials in both the US and Europe.
The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

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+++ Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health) reviews

Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health)

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"Statistical Monitoring of Clinical Trials: A Unified Approach (Statistics for Biology and Health)" Feature

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this book offers statisticians an accessible, incremental approach to understanding Brownian motion as related to clinical trials.

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Monitoring Clinical Trials: A CRAs job description Description

What is a clinical research associate?"... is a question I hear time and time again. In a nutshell, it is an exciting job in the healthcare industry and this book will break it down in easy to understand steps. The job of a clinical research associate can sometimes look complex. It does indeed have a lot of moving parts, but, it is straight forward and can be easily picked up. However, because it requires a detailed oriented and hard working individual to monitor trials, JP Holdasham decided to share his experiences with other folks interested in learning more about being a clinical research associate(CRA) or monitor.

Like every other career, you learn the core components; become an expert in them and as your experience increases by... “doing the job" you become an expert. BY working with for Contract research organizations (CRO) as a CRA you participate in new drug trials that could involve Phases I – Phase IV. You work with the principal investigator (PI), the clinical research coordinator (CRC) under GCP and ICH guidelines to ensure the well being of the trial subjects and integrity of the trial.

Monitoring Clinical Trials will introduce you to the core duties of a clinical research monitor, how they prepare for any of their monitoring visits

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The CRA's Guide to Monitoring Clinical Research, Third Edition Description

The CRA's Guide to Monitoring Clinical Research, now in its third edition, continues to be a key 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. With helpful tips and strategies, checklists, personal experiences, key takeaways and exercises, plus new chapters on clinical trial roles and responsibilities, monitoring for device and biologic trials, globalization of studies, EDC and more, The CRA's Guide is a must-have training and educational tool that you ll refer to again and again.

Topics include: -A comprehensive review of CRA roles and responsibilities
-Understanding regulations and GCPs
-Study initiation and monitoring plans
-Recruiting and retaining study subjects -The informed consent process
-Conducting adverse event and safety monitoring
-Preparing for audits and detecting fraud
-The future outlook
-Job descriptions and current academic programs
-Devices and Biologics
-Managing Multi-national Trials
-IRBs and Data Safety Monitoring Boards
-Exercises with Answers

Recommended for: -Novice and experienced CRAs
-Health professionals interested in pursuing a career as a study monitor
-Instructors conducting training and educational programs

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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

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