Protocol Development and Implementation - Lecture 6

Explore protocol development and implementation in clinical and translational research through a 48-minute lecture from the NIH Clinical Center's summer course. Delve into drafting protocols, study agent overviews, and study design. Examine case studies on study populations, exclusion criteria, and scheduling procedures. Investigate the complexities of protocol logistics, safety oversight, and data capture. Gain insights into unique NIH resources, connect with researchers and program administrators, and discover potential NIH career opportunities. For further information about this comprehensive learning experience, contact the course coordinator at [email protected].

Intro
DRAFTING THE PROTOCOL
STUDY AGENT OVERVIEW
STUDY DESIGN
CASE QUESTIONS: STUDY POPULATION
CASE EXAMPLE: EXCLUSION CRITERIA
STUDY SCHEDULE AND PROCEDURES
CASE QUESTIONS: SCHEDULE OF PROCEDURES
CASE EXAMPLE: SCHEDULE OF PROCEDURES
PART 2: THE COMPLEXITY OF PROTOCOL LOGISTICS
SAFETY OVERSIGHT AND DATA CAPTURE
CASE QUESTIONS: LOGISTICS