Building a Clinical Research Handbook: A Guide for Principal Investigators in Healthcare Settings
Perez-Torres, Nancy Yanira
MetadataShow full item record
Clinical research refers to studies conducted on humans to determine the safety and effectiveness of diagnosis and treatment. In clinical research it is necessary to adhere to federal regulations to protect human subjects. Clinical research conducted at medical centers provides a higher number of medical participants. These human clinical studies must be conducted with the appropriate consent given to participate in medical research. The purpose of this Capstone Project was to build a clinical research handbook to be used as a reference guide for physicians and principal investigators of regulations and ethical policies throughout medical research at Wilma N. Vazquez Medical Center. This handbook provides a clinical research framework following federal guidelines and legal policies for principal investigators (PI) in medical research. The handbook must use clear language and organizational structure to present clinical research design topics, which explain best practices for creating an ethical framework. Once approved by the author’s Capstone Project instructor, the clinical research handbook will be submitted for review to the institutional medical director. After approval, the clinical research handbook will be available for physicians and PIs starting in January 2021. This clinical handbook starts by discussing various ways for the clinical studies to be organized and executed, including a step-by-step approach to research documentation while managing regulatory and ethical concerns in research. As a result, the handbook is intended to provide accessible information about clinical practice standards and administrative topics to increase clinical research compliance.