Protocol Development and Execution: Beyond a Concept

When clinicians have a moment of clarity, a real-world form of inquiry surfaces and piques their curiosity. Perhaps, they are thinking of a new drug combination or a modification to an existing device, a novel genomic approach emerges in a discussion with preclinical colleagues, or a perceived trend in patient outcomes gives way to a longitudinal surveillance study. There has been renewed interest in investigator-initiated studies (IISs), with steady growth over the last decade. This module introduces investigator-initiated research, explains the steps in the protocol execution continuum, and provides learners with an overview of how to assemble a protocol execution roadmap. It concludes with important elements to help facilitate successful protocol development and execution and discusses common pitfalls and factors critical to the success of investigator-initiated research.

Recommended Use: Required
ID (Language): 20326 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Michelle Mack, PhD - Duke University School of Medicine

Grant writing and protocol development are vastly different functions. A grant application is a scientific outline that may include multiple studies, whereas a protocol represents a technical manual for a single study. Unlike a grant application’s audience and intent, which is to convey highly scientific concepts to expert scientific reviewers, a protocol provides a moderate level of detail to co-investigators, the Institutional Review Board (IRB) (or ethical review board), and the study team. A protocol guides study execution and helps researchers pace the conduct of the research elements to ensure scientific validity, subject safety, reproducibility, and regulatory compliance.

This module aims to demystify the art of protocol writing. It details the essential elements of a protocol, outlines supplemental protocol components, and promotes thoughtful consideration of the amount of information that a protocol should include. This module also includes templates and guides to assist in the development of key protocol sections.

Recommended Use: Required
ID (Language): 20327 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Michelle Mack, PhD - Duke University School of Medicine

Federal law (the Food, Drug, and Cosmetic Act of 1938) requires the U.S. Food and Drug Administration (FDA) to review and approve all investigational products, including new drugs, biologics, and medical devices in the United States. More specifically, the FDA reviews documented verification of the safety of a drug, biologic, or medical device prior to being marketed. The FDA reviews and evaluates regulated products through the evidence presented as a result of clinical investigations performed by sponsors.

In this module, learners will explore the various types of pre-IND meetings and the FDA meeting process. An overview of the different FDA centers or offices and their primary areas of jurisdiction is also presented. The module also provides an overview of the roles and responsibilities of the sponsor, investigator, and contract research organization (CRO) in the conduct of a clinical trial. The module concludes with a discussion of the different application types as well as the materials necessary for submitting a thorough and compliant investigational new drug and/or investigational device exemption package to the FDA, and the subsequent FDA review process for each application type.

Note: This module does not replace the comprehensive CITI Program courses on Good Clinical Practice (GCP) and Human Subjects Research (HSR).

Recommended Use: Required
ID (Language): 20328 (English)
Author(s): Carrie Thomas, BS MT(ASCP), CSSGB - Moffitt Cancer Center

The protection of subject safety is the most important responsibility for anyone engaged in the conduct of human subjects research. Safety depends on prompt, accurate, and thorough review and reporting of any event that may affect subject health as well as the routine assessment of data integrity.

This module will discuss the key components of a data and safety monitoring plan (DSMP) within a clinical trial and what factors investigators should consider during protocol development.

Recommended Use: Required
ID (Language): 20329 (English)
Author(s): Jennifer Hofecker-Burgess, MS - Erlanger Health System; Michelle Mack, PhD - Duke University School of Medicine

Research data are the tangible product that research subjects contribute throughout a study. A meticulous final dataset is the pinnacle of a research study and has the power to reveal patterns, answers, and insights. Aggregated, reproducible data that are methodically collected from reliable sources, preserved, and accessible are critical to a research study. Rich datasets often stimulate new ideas and inquiries, which further propel investigators on a journey toward discovery, comprehension, and knowledge. Research data can be complex and derive from a variety of sources and formats. Therefore, a concrete data management plan (DMP) is fundamental to preserving data integrity and ensuring that the data are comparable and sufficient to answer the research question. A DMP is a formal guide for the collection, analysis, dissemination, and retention of research data. This module discusses the data lifecycle, including key concepts, regulations, and best practices to ensure that data are reliable and reproducible. Learners will explore the key components of a DMP in detail.

Recommended Use: Required
ID (Language): 20330 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Michelle Mack, PhD - Duke University School of Medicine

Subject recruitment, engagement, and retention are critical to clinical research. Yet, subject participation in clinical research remains low and dropout rates remain high. Various factors can impact whether a trial successfully meets its recruitment goals. This module discusses important protocol design considerations that can significantly impact the potential for reaching recruitment goals. Further, it details strategies, tools, and techniques for the recruitment and retention of subjects in clinical research studies.

Recommended Use: Required
ID (Language): 20331 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Michelle Mack, PhD - Duke University School of Medicine

Every successful project starts with a carefully crafted roadmap (or project plan) and involves effective project management. A key tenet of project management is that time spent planning saves time during the execution of a project. In the research context, a project plan serves as the framework from which all corresponding study activities are set, including protocol development, study conduct, subject enrollment, and data management. Project planning should coincide with protocol development so that researchers can consider and capture key targets, timelines, and deliverables throughout all stages of development.

This module explores the principles of project management and how they apply to a research project, the value of planning, project management best practices, and tips and tools for planning beyond the protocol and study design when developing a research study and the corresponding documents. Further, it combines important components discussed throughout this course such as variety in data management plans, statistical analysis, monitoring, and recruitment and retention.

Recommended Use: Required
ID (Language): 20332 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Michelle Mack, PhD - Duke University School of Medicine

This module provides a practical approach to multi-site study implementation in the United States. It explores planning steps, strategies, best practices, and helpful tips for multi-site activities. With appropriate and careful planning, researchers can mitigate delays and avoid a compromise in quality and unnecessary financial drain. The module also discusses the challenges and benefits of multi-site research; describes effective collaborations; and outlines coordinating center (CC) activities, responsibilities, and the associated structure required to make such endeavors successful.

Recommended Use: Required
ID (Language): 20333 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Heather Chen, MPH, CCRP - Cedars-Sinai Medical Center

The current research environment demands an effective financial management strategy; yet, many researchers shun the daunting task even when compelling evidence informs them otherwise. Control of costs and accounting during study management is a well-known challenge for researchers, small and large sites, contract research organizations, and sponsors.  This module covers various elements associated with the financial management of research studies. Specifically, it focuses on basic principles and regulations, the determination of study costs versus standard of care, federal and private payer coverage, ethical considerations, budget calibrations, cost-sharing principles, and industry partnerships.

Recommended Use: Required
ID (Language): 20334 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Jennifer Hofecker-Burgess, MS - Erlanger Health System

As the healthcare industry shifts to value-based care and the increasing costs of clinical research face tremendous public scrutiny, the need for effective financial management in clinical research is more crucial than ever. Often, however, researchers have neither the time nor the background to account for the financial nuances of a clinical research study. Financial management of a research study may be difficult due to its inherent complexity and constant changes in the protocol.

Few researchers have access to sophisticated systems to manage the financial aspects of a project. Often, projects require manual tracking in a spreadsheet, the clinical and financial languages are distinct, and cross-education is essential for the successful management of funds. Researchers who understand basic accounting principles and establish reliable activity-tracking mechanisms can prevent common errors, increase transparency, and ensure informed decision-making.

This module describes useful approaches for monitoring clinical research financial activity after the project has been awarded. These approaches include the responsible stewardship of dollars, recording of payments and expenditures, and financial reporting. While the specific requirements may vary slightly by the funding source (such as federal, private, and not-for-profit), the underlying principles, concepts, and common practices serve as a foundation with broad applicability.

Recommended Use: Required
ID (Language): 20335 (English)
Author(s): Therica Miller, MBA, CCRP - Hartford Healthcare, MSK Cancer Alliance; Jennifer Hofecker-Burgess, MS - Erlanger Health System