Books

Clinical Research Management: Complimentary Materials

The complementary materials in this book have been created based on years of teaching and working in the clinical research management field. The original book A CLINICAL TRIAL WORKBOOK: Material to Complement Research Education and Training Programs was published in 2016. The intent was to provide tools and resources to assist in the training and education of present and future professionals in the field. The materials in that book have been used in many different courses including ethical conduct of research, contracts and budgets, scientific review boards, clinical research operations, monitoring of clinical trials, leadership and project management.

Since 2016, we have received many requests for additional materials. This new book is a compilation of materials from the original book (many revised) and additional materials requested. Materials include multiple protocols (including medical device), consent forms (including an assent form), clinical trial study site and sponsor budgets, clinical trial agreements, data management materials, recruitment ads, case report forms (CRFs), and other study documents. This book includes a study site Business Plan. The Plan includes study roles, facility information, site background, equipments, staff backgrounds and qualifications, staff training program, pay rates and more. It can be used to create assignments and activities such as developing a study budget; determining feasibility of a site for a study based on qualifications, resources, and space; data management plans; recruitment plans and activities; CRFs; and more.

Feedback from faculty and trainers that have used the materials in the previous book include:

“Until I found this book, I struggled to find materials to use in my budget management course. I have used the protocol for students to develop clinical trial budgets. I look forward to the new book with its additional materials and site business plan to incorporate more activities in my course.”

“We have used the protocol to have students create CRFs for various visits. It is a practical, hands-on experience for them. They learn much more than they would by just reviewing a CRF.”

“I have included this book in my research ethics course for the past 3 years. The materials are relevant to human subject research and demonstrate how to be compliant and ethical with study documents. Students also review the documents in relation to FDA CFRs to determine if they are compliant and how they might be improved.”

Managing Clinical Trial Budgets & Contracts

This textbook is designed for use in clinical trial management and regulatory programs for courses covering budgeting for clinical trials and and clinical trial agreement review, negotiation and management. It provides the reader with a roadmap to building budgets and reviewing contracts. It provides a step-by-step process for creating a budget  and a comprehensive review of clinical trial agreements including definitions, clauses, contract terms and language, and applicable laws and regulations. The authors provide tips throughout the books and each chapter concludes with review questions and scenarios for application of knowledge.

Pfeiffer, JoAnn and Windshciegl, Marilyn with guest author Garhan, Hailey. (2021). LAD Custom Publishing, Inc. ISBN #: 9 780840 174000

A Practical Guide to Managing Clinical Trials

A comprehensive guide to conducting clinical trials. This textbook is designed clinical research management academic programs and for individuals working in research site operations. This user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and study close-out. Topics include staff roles and responsibilities, budget and contract review and management, subject study visits, data management, event reporting, research ethics, audits and inspections, consenting process, IRB oversight, FDA regulations and GCPs. 

Pfeiffer, JoAnn & Wells, Cris. (2016) CRC Press. ISBN: 978-1-138-19650-6 

Making the Case for a Project: Needs Assessment

Jones, C.T.,Roussel, L. (2018). Chapter 9: Making the Case for a Project: Needs Assessment. In: Harris, J.L., Roussel, L., Dearman, C., Thomas, P.L. Project Planning and Management: A Guide for Nurses and Interprofessional Teams; 3^rdEdition. Jones & Bartlett Learning. ISBN:978-1-284-14705-6.

Instructor’s and Trainer’s Exercise Guide: Clinical Research Operations

Pfeiffer, J and Shah, K, Edited by: Wells, C. (2018) Instructor’s and Trainer’s Exercise Guide: Clinical Research Operations

A Practical Guide to Managing Clinical Trials

Pfeiffer, J and Wells, C (2017). A Practical Guide to Managing Clinical Trials. CRC Press. ISBN: 978-1-138-1965.

A Clinical Trial Workbook to Complement Clinical Trial Education & Training

• Shah, K., Wells, C., Pfeiffer, J. (2017) A Clinical Trial Workbook to Complement Clinical Trial Education & Training. Second Edition. LAD Custom Publishers.

Evidence-Based Practice: An Integrative Approach to Research, Administration and Practice

Buckner, E., Hall, H.R., Roussel, L.A., Jones, C.T.(2016). Chapter 5: Navigating the Institutional Review Board (IRB).  In: Hall, H.R. & Roussel, L.A.(2016, August). Evidence-Based Practice: An Integrative Approach to Research, Administration and Practice: 2^ndEdition. Jones & Bartlett Learning. ISBN-13:978-1284098754

Clinical Research Nursing: Scopes and Standards of Practice

American Nurses Association & International Association of Clinical Research Nurses (2016). Clinical Research Nursing: Scopes and Standards of Practice. Silver Spring, MD: ANA & IACRN (Contributor: Carolynn Thomas Jones). ISBN: 9781558106758

Managing and Negotiation Budgets and Clinical Trial Agreements

• Pfeiffer, J. and Windschiegl. (2016). Managing and Negotiation Budgets and Clinical Trial Agreements. LAD Custom Publishers. Available in electronic and hard copy. LAD Publishers.