Book Series

Thompson CenterWatch (Boston) has released a set of five books that are excellent resources for the clinical trials industry and more particularly the clinical trial site. The series includes:

• A Guide to Patient Recruitment and Retention.
• Protecting Study Volunteers in Research.
• A CRC’s guide to Co-ordinating Clinical Research.
• Becoming a Successful Clinical Research Investigator.
• The CRA’s guide to Monitoring Clinical Research.

Each book in this series contains a test which is beneficial for training and assessment for trial site personnel.

• ‘A Guide to Patient Recruitment’ (Anderson, D. 2004) provides useful information and strategies on the recruitment and retention of clinical trial participants. This book extensively details the current issues driving the recruitment trend in the clinical trials sector. It outlines the privacy issues and various regulations and requirements that guide patient recruitment and retention approaches. This book introduces various strategies to accurately estimate and fulfil recruitment targets and suggests focusing on superior customer service to retain trial participants. ‘A Guide to Patient Recruitment’ (Anderson, D., 2004) is an essential resource for a Clinical Trial Site due to the demanding targets set for participant recruitment and retention.
• ‘A CRC’s Guide to Co-ordinating Clinical Research’ (Woodin, K., 2004) provides essential information for a Clinical Research Co-ordinator (CRC) and their manager. This book assists CRCs to clearly identify regulations governing clinical research such as ICH/GCP and their application to the CRC role as well as the tools and processes required to manage clinical trials from set-up to completion. All aspects of protocol adherence, informed consent, HREC communication, case report forms, SOPs, study processes, study closeout, adverse events and safety monitoring and audits are extensively reviewed throughout this book. The current, dynamic information provided in this book will be an invaluable resource to a CRC at any clinical trial site.
• ‘Protecting Study Volunteers in Research’ (McGuire,C., & Chadwick, G., 2004) is a manual targeted at Investigator Sites for all staff members including the Investigators, CRCs and support staff.   Privacy and protection of participant rights is a contemporary issue that needs to be addressed at a trial site level. This book reviews the human research process and history, legislative requirements, the roles and responsibilities of the HREC and the Investigator, privacy, conflicts of interests and special ethical concerns in Clinical Research. 
  This book provides all professionals in the Clinical Trial Industry, but particularly those at a Trial Site, with comprehensive guidelines to protecting study participants in the research process and explores the need for trial site personnel to become participant advocates.
• ‘Becoming a Successful Clinical Research Investigator’(Ginsberg, D., 2005) is an excellent resource particularly for potential, new or experienced investigators. This book explores the impact that clinical research will have on a doctor’s practice, patients and legal liabilities. It outlines an overview of the clinical trial process and recommends various techniques for business development, staffing and resources at a trial site. This is an excellent book for a trial site to be utilised as a reference tool for an experienced investigator and a training guide for the new or potential investigator.
• ‘The CRA’s Guide to Monitoring Clinical Research’ (Woodin, K., & Schneider, J. 2003) is a tool for a Clinical Research Associate (CRA) or conversely, it can be utilised by a trial site to gain a valuable insight into the role of a CRA. This book explores the CRA role, and the regulations they must adhere to in the research process. It closely examines each research process from initiation to close out and gives guidelines of how the CRA must interact with all parties including the trial site staff, the investigators, the HRECs and regulatory authorities.

References

Anderson, D., (2004). A Guide to Patient Recruitment and Retention. Boston: Thompson CenterWatch.

Ginsberg, D. (2005) Becoming a Successful Clinical Research Investigator. Boston: Thompson CenterWatch.

McGuire,C., & Chadwick, G. (2004) Protecting Study Volunteers in Research. Boston: Thompson CenterWatch.

Woodin, K., & Schneider, J. (2003)  The CRA’s Guide to Monitoring Clinical Research.  Boston: Thompson CenterWatch.

Woodin, K., (2004)  A CRC’s Guide to Coordinating Clinical Research. Boston: Thompson CenterWatch.

QCTN strives to deliver up-to-date, innovative resources to assist members to gain the information necessary to deliver quality clinical trial services. Through this initiative, members are able to order these books through QCTN. Please contact marketing@qctn.com.au for further information.

Standard Operating Procedures

To ensure continuity of quality trial procedures within a clinical trial site, it is imperative that a trial site creates, maintains and regularly educates staff on their Standard Operating Procedures (SOPs). QCTN offers a service that will create tailored SOPs for your site and train your staff on these procedures.  If you would like further information on this service, please contact sos@qctn.com.au.