Responsible Research A Guide for Coordinators.

Responsible Research A Guide for Coordinators By Carol A Fedor, Philip A Cola, and Christine Pierre, Eds. Remedica

Chapters 1 and 2: The Evolving Role of the Clinical Research Coordinator; Guiding Principles and Regulations

The authors present historical information regarding the identity of clinical research coordinators (CRC) and background of their emerging role in these respective chapters. These chapters provide research personnel with a framework describing a CRC's main responsibilities, activities, education, training, certifications and average compensation. They also show the impact of CRC training and certification on potential earning abilities. These chapters also provide a real world understanding of the difficulties facing the CRC and clinical research sites such as workload and turnover.

Also included in this area are contrasts and comparisons of regulatory authorities, i.e., the US Food and Drug Administration (FDA) and Code of Federal Regulations, and the European Union (EU) and Japan International Conference on Harmonization (ICH). Summations of the responsibilities and oversight of these regulatory bodies are given. A detailed reference list regarding these regulations and guidelines are provided. A brief discussion of the CRC's responsibilities and how they relate to these guidelines is also available.

Chapters 3, 4, 5 and 6: Ethics and Human Subjects Protection; Responsible Conduct of Research; The Informed Consent Process; Pediatric Informed Consent and Assent 

Chapters 3 through 6 focuses on the human subject providing historical information e.g., how the regulations and guidelines were established. These chapters also discuss components of ethical research and related responsibilities of the CRC providing examples for the research professional.

Seven areas of responsible research--conflicts of interest, mentoring, authorship and publication, data management, ethics and morality, research misconduct, and human subject protection--are discussed. These topics are reviewed in detail providing identifiable points for CRCs during their conduct of research.

As a CRC, the most important roles of the position is to ensure that research participants make a knowledgeable and educated decision to participate in the study that is being explained. Chapter 5 includes information regarding documentation and confirmation of understanding by subjects ensuring all parties are appropriately informed before the commencement of the clinical research study. The required elements of a consent document are listed, as well as the regulations describing each of these essential elements. Pediatric research poses additional difficulties as the authors explain. Assuring the parent is educated and knowledgeable regarding pediatric clinical trials may be a difficult task. However, the CRC's arduous task is to ensure that pediatric patients understands and agrees with their participation in the clinical research being presented to the best of their ability or cognitive level. Tables illustrate tips for child friendly language, questions to consider when preparing an assent and guidelines on how to handle compensation to the pediatric patient. Information in these chapters is clear, concise and can be practical tools.

Chapters 7, 8, 9, 10, and 11: Study Implementation and Startup; Recruitment and Retention of Research Subjects; Documentation; Assuring Quality in Clinical Trials: Monitoring, Audits; and Inspections, Communication

Chapters 7 through 11 address practical aspects of conducting clinical research. Study designs and phases of clinical trials are provided for background to assist in the protocol evaluation. These guidelines help the CRC and other research personnel to understand the feasibility, practical and financial implications of the study. The authors provide a table listing many documents usually submitted to the Institutional Review Board (IRB) to prepare for opening a research study. Although many of these documents require IRB review and approval, some may need to be reviewed by other departments within the organization. Note: This reviewer recommends that your institution's IRB policies and SOP's be reviewed and adhered to when completing the documents necessary for IRB review. The tables provided are functional and practical in organizing a CRC for initial study implementation. They also assist a CRC in determining aspects and departments that should be included and trained along with the CRC for initiation of a clinical research study.

Chapter 8 describes issues that surround recruitment and provides options to assist in this area. It also explains the consequences of not meeting the contracted goals. Subject recruitment is discussed in terms of how it is affected by the study contract. The authors provide insight into how the multidisciplinary approach within an organization can assist to ensure awareness and further participation. Tables that include questions and alternatives ways to recruit are included. The authors also provide information supporting advertising guidelines as well as discussing advantages and potential disadvantages of advertising and marketing the institution or research site. The necessary components to recruitment including screening, protected health information, informed consent, and randomization and blinding are neatly outlined. The detail provided is a practical guide to the mechanisms required to meet the obstacles that may prohibit meeting the goals of clinical research.

Chapter 9 provides an overview of documentation that is essential to the conduct of clinical research as well as associated definitions. This information is a realistic guide to all required documents indicating how best to set up files within the department of clinical research to guarantee compliance and aide in the monitoring and auditing processes. It further elaborates on the Adverse Event process and reporting, the differences in the classifications of Adverse Events and the necessary documentation needed from the CRC and Principal Investigator to ensure regulation compliance. Tables are included to simplify the information.

This chapter also discusses proper documentation, including how to correct errors and answer queries and data clarification forms. This topic is also addressed in relation to the monitoring and auditing process. In addition, this chapter addresses the important and costly issue of data retention and provides the reader with questions to ask the sponsor to ensure compliance and potential financial implications.

Chapter 10 also includes responsibilities of the clinical research team. The author lists and describes the regulations under which the monitor or Clinical Research Associate (CRA) is acting when visiting and reviewing the site. This information provides the CRC with the perspective of the CRA position that may enhance the working relationship. Differences between monitoring and auditing/ inspections are discussed and the potential consequences are reviewed. Recommendations are provided on ways to prepare for each process and to supplement the CRC's performance to provide quality data.

Chapter 11 emphasizes the importance of communication in the CRC's role. The authors discuss, accounting for institutional or organizational differences, possible departments and personnel where an important role to communicate and the information to communicate. They further provide input on the significance that is placed on the team effort that clinical research entails. This effort can be achieved through active and effective communication. Lastly, effective communication with study participants and the potential issues and concerns that should be included during discussions with them regarding their participation in the clinical trial are examined.

Chapters 12 and 13 Learning: A Continuous Journey and Future Trends: the Professionalization of the CRC

Chapter 12 evaluates the vision for the CRC. Different means of obtaining the most optimal training for the clinical research coordinator are assessed. Various professional organizations and websites are listed for reference. The importance of CRC certification is discussed. Other career opportunities for the clinical research coordinator are presented.

The importance of the humanistic side of the CRC's responsibilities are revealed and how it is maintained within the current environmental pressures set forth by regulations and sponsor demands. The authors emphasize the importance of the CRC's role in the protection of human subjects through appropriate and adequate communication. CRCs can obtain this information through adequate and required training.

The book's title, Responsible Research--A Guide for Coordinators, may lead the reader to believe that the focus and emphasis will be on the moral and ethical aspects of clinical research. Although ethics is the consistent underlying tone of why certain aspects of the position are necessary, the information included in the book encompasses a larger overview of the responsibilities of the clinical research coordinator that far surpasses the book's title. With many contributors to this book, there are wide varieties of perspectives included. The book is written clearly and succinctly and is a valuable resource for the clinical coordinator both in the practical aspects of performing the job duties as well preparation for the CRC certification exam. I highly recommend this book to all research professionals with any interest in clinical research who have oversight of CRCs and the clinical research process. This book should be on every research administrator or manager's credenza for understanding and reference!

Rosemary Stefiniw, RN, BS, CCRC 

Oncology Research Manager

Atlantic Health

Morristown, NJ