What is a Protocol?
A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.
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 study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
A protocol is a study plan to conduct clinical trials or investigations. The plan is carefully designed to safeguard the health of the subjects as well as answer specific research questions. A protocol describes who may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
Clinical trials use written guidelines called protocols. The protocol explains what the trial hopes to accomplish, how the trial will be carried out, and why each part of the trial is necessary. For example, the protocol includes: • The reason for doing the trial • How many people will be in the trial • Who is eligible to take part in the trial • What study drugs participants will need to take • What medical tests participants will have and how often • What information will be gathered Every doctor or research center that takes part in the trial uses the same protocol. This makes sure that patients are treated identically no matter where they are receiving treatment, and that information from all the centers taking part can be combined and compared. Protocols are written by the trial sponsors (those conducting the trial) and must first be reviewed by an Institutional Review Board (IRB) at each participating hospital or medical center before they can begin. IRBs are committees that over
