Introduction

Research administration is much like an orange—remove the peel, and what appears to be simple is actually made up of many connected yet separate sections. Likewise, investigators conducting clinical research trials are responsible for managing the many administrative aspects, or sections, of their research enterprise. This process involves regular interactions with their institution’s administrative infrastructure and personnel in Sponsored Programs, finance, compliance, and the institutional review board (IRB).

This book demonstrates our strategy for managing our portfolio of clinical trials and running a small research enterprise. We will show you our tactics, as well as how we take business processes and examples from clinical or other professionals and adapt them for our use in research. We define and briefly explain important items, frame the items to demonstrate how they fit within the greater scope of work, and finally connect the items—through real-world examples—with what the research professional is seeing at the research site.

Business operations are as vital to a successful research enterprise as ethical decision-making, compliance with good clinical practice (GCP), and well-designed study protocols. We present the responsibilities for strategic planning, maintaining a positive operating margin, and putting the regulations into everyday practice as examples and “idea starters” for you.

New investigators typically focus on the clinical trial protocol and may not realize the time commitment and resources involved with administrative activities. Negotiating the study contract, navigating the regulatory approval process, and securing resources such as research staff, testing services, and investigational pharmacy support are immediate and necessary tasks. These tasks are just the beginning, because study activities typically involve preparing interim reports, reconciling grant accounts, supervising research staff, and processing time sheets and payroll. Compliance with internal and external regulatory authorities is required, and routine audits are regular events.

At academic medical centers, where research activities are a core function, administrative activities may be handled in a variety of ways. Some typical organizational strategies include having an investigator do everything, having a portion of a department’s administrator’s time dedicated to research, or creating a centralized administrative infrastructure for either multiple investigators or the institution’s personnel to use. Research professionals working within any of these structures should be able to adapt the content of this book for their use.

Let’s take a brief look at how this book is organized:

• We start in Chapter 1 with a look at the purpose and value of administrative infrastructure for the investigator’s research enterprise. The research enterprise, a scientific and business endeavor, benefits from careful planning and a solid understanding of the logistics needed to carry out the protocol and administrative responsibilities.

• Chapters 2, 3, and 4 present unique aspects for managing research-related information, workplace responsibilities, and professional relationships.

• The complex financial responsibilities for clinical research trials go far beyond negotiating a study budget. Managing a portfolio of studies happens when investigators makes deliberate choices to move from conducting “convenience” trials, the ones that randomly cross their paths, to strategically managing the direction and type of research they want to conduct. Chapter 5 will help you deconstruct your complex medical practice setting, understand ways to manage your grant accounts, and provide ideas for navigating through the research revenue cycle (RRC).

• Learning from and living with research guidance documents and regulations means translating them into everyday research practice. Chapter 6 takes you through a variety of common regulatory situations using explanations, examples, and related regulations.

Throughout these chapters, we’ve included various tips as well as real-world examples to help you better manage the administrative side of your research enterprise and to help you see what others who have gone before you have done. Just look for the boxes marked “Tip” and “Example” for easy reference.

Two additional features in each chapter include “Quality Connection” and “Key Take-Aways.” The purpose of “Quality Connection” is to help identify the role quality plays in every aspect of research activities. This section, which appears near the end of each chapter, will identify and, wherever possible, present some practical approaches for quality initiatives at the research site. The purpose of “Key Take-Aways” is to highlight the core concepts presented in the chapter.

This guidebook has been written for research professionals who want a deeper understanding of strategic planning, financial management, and regulatory implementation. We hope you find it useful.