Navigating Clinical Trials: Essential Knowledge for Dermatologists-Clinical Research Site Operations

Video Transcription

Video Summary

Dr. Ted Lane, a board-certified dermatologist and CEO/CMO of Sanova Dermatology, presents on clinical research site operations, emphasizing the complexity of launching clinical trials. A clinical trial, often overseen by a CRO (Contract Research Organization) on behalf of a pharmaceutical sponsor, involves various steps, starting with an NDA and a feasibility questionnaire to gauge a site's capability. Essential roles include feasibility, contracting, and regulatory specialists who handle logistics, contract negotiations, and compliance with regulations. Standard Operating Procedures (SOPs) are vital, acting as the "bible" for site operations, ensuring consistency, compliance, and efficiency, and must be kept updated. Dr. Lane advises on personnel involvement, maintaining updated SOPs aligned with current regulations, and underscores the importance of adhering to them, particularly during FDA audits. His comprehensive overview is designed to demystify the process and offer insights into successful clinical trial operations.

Asset Subtitle

by Ted Lain, MD, FAAD

Keywords

clinical trials

dermatology

SOPs

FDA audits

contract negotiations

regulatory compliance