What is a trial protocol?
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the clinical study. While in a trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Related Questions
- I am an investigator developing a protocol for a gene transfer clinical trial. What are the first things I need to do to prepare for a review of my trial by the RAC?
- Is there potential overlap in what might be considered for a clinical management trial protocol and a proof of concept study?
- Please give an overview of the trial protocol?
