In order for every study to work appropriately and to answer a study specific question, every clinical trial must have a protocol. The protocol is the study plan on which a clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial (Study Population); the schedule of tests, procedures, medications, and dosages; and the length of the study.
The protocol will give guidance to our study coordinators and doctors on how to conduct the study at our site. This is why a volunteer are asked to follow specific rules, including coming in for study visits within a specific time frame. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
The study sponsor collects all of the data from Rochester Clinical Research and it’s volunteers and compiles it with other sites (just like RCR). The data they collect will determine if the treatment or vaccine is safe and effective. This will ultimately lead to the data needed to have the vaccine or treatment to be approved and available to the general public.