This course provides a tactical approach to clinical protocol development and implementation. The course includes evidence-based strategies, best practices from field experts, and standard tools to aid the protocol authoring process. A well-thought-out and well-written protocol ensures high-quality science and strengthens the quality of the endpoints. With an effective protocol, investigators can accelerate development and study completion, ensure regulatory and data compliance, and avoid unnecessary financial drain.
- Ideal for investigators new to creating and executing their own protocols.
- Covers key topics including parts of a protocol, data management, considerations for multi-center activities, and financial management.
- Includes videos, visual aids, and case examples.
Clinical Investigators, Faculty, Sponsor-Investigators, Recently awarded grant recipients with concepts in the clinical trial setting, Project Scientists, Project Managers, Program Manager, Advanced Research Coordinators, Research teams charged with assisting researchers with proposal execution, Students
Meet the Authors
Heather Chen, MPH, CCRP – Cedars-Sinai Medical Center
Heather Chen has 15+ years of clinical research experience in oncology. She is a Research Program Administrator in Metrics and Analytics at Cedars-Sinai Medical Center. Heather works with Cancer Clinical Trials Office leadership to establish policies and procedures for quality control and quality assurance of operational data.
Jennifer Hofecker-Burgess, MS – Erlanger Health System
Jennifer Hofecker-Burgess has 15+ years of clinical trials experience, management of clinical research operations for investigational drug and device, industry and academia clinical trial management/oversight experience, proposal/contract development and negotiations, financial direct oversight of clinical trials, including pre/post award, invoice and payment receipt, and accounts receivable reconciliations.
Michelle Mack, PhD – Duke University School of Medicine
Michelle Mack currently serves as an Associate Director for Clinical Research within the Duke Office of Clinical Research, and works with Investigators in the Duke University School of Medicine to develop and manage their research initiatives.
Therica Miller, MBA, CCRP – Hartford HealthCare, MSK Cancer Alliance
Therica Miller is nationally recognized research executive with over 15 years of experience in research administration in both industry and academia. She has dedicated her career to simplifying the clinical research system to accelerate the discovery of new therapies. She holds an MBA and is a Certified Research Professional. She developed CITI Program’s course: Protocol Development and Execution: Beyond a Concept.
Carrie Thomas, BS MT(ASCP), CSSGB – Moffitt Cancer Center
Carrie serves as the FDA Regulatory Liaison at Moffitt Cancer Center (MCC) in Tampa, FL. She provides FDA regulatory oversight for all clinical trial activities conducted under MCC Investigator held Investigational New Drug and Investigational Device Exemptions.