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

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. The so-called B-value approach to monitoring allows us to use, for different types of trials, the same boundaries and the same simple formula for computing conditional power. Although Brownian motion may sound complicated, the authors make the approach easy by starting with a simple example and building on it, one piece at a time, ultimately showing that Brownian motion works for many different types of clinical trials.

The book will be very valuable to statisticians involved in clinical trials. The main body of the chapters is accessible to anyone with knowledge of a standard mathematical statistics text. More mathematically advanced readers will find rigorous developments in appendices at the end of chapters. Reading the book will develop insight into not only monitoring, but power, survival analysis, safety, and other statistical issues germane to clinical trials.

Michael Proschan, Gordon Lan, and Janet Wittes are elected Fellows of the American Statistical Association. All have spent formative years in the Biostatistics Research Branch of the National Heart, Lung, and Blood Institute (NHLBI/NIH). While there, they were intimately involved in the design and statistical monitoring of large-scale randomized clinical trials, developing methodology to aid in their monitoring. For example, Lan developed, with DeMets, the now widely-used spending function approach to group sequential designs, whose properties were further investigated by Proschan. The B-value approach used in the book was introduced in a very influential paper by Lan and Wittes. The statistical theory behind conditional power was developed by Lan, along with Simon and Halperin, and was the cornerstone for the conditional error approach to adaptive clinical trials introduced by Proschan and Hunsberger. All three authors have expertise in adaptive methodology for clinical trials.

Michael Proschan is a Mathematical Statistician at the National Institutes of Health; Gordon Lan is Senior Director of Biometrics at Johnson & Johnson Pharmaceutical Research and Development, L.L.C.; Janet Wittes is President of Statistics Collaborative, a statistical consulting company she founded in 1990.

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

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




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

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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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Main Features : The CRA's Guide to Monitoring Clinical Research

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