What is a Protocol?
: On the Internet, the word “protocol” refers to a set of rules for communicating. Two programs or computers that follow the same rules are able to exchange information, even if they don’t run the same operating system and are not made by the same company. Sometimes protocols are “layered” on top of other protocols, taking advantage of what’s already there and adding additional capabilities. Examples of Internet protocols include the HTTP protocol spoken by web browsers and web servers, the FTP protocol for transferring files, and the TCP/IP protocols on which both of these are based.
A protocol is a study plan on which all clinical trials are 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; the schedule of tests, procedures, medications, and dosages; and the length of the study. 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.
All clinical trials must be conducted according to strict scientific and ethical principles. Every clinical trial must have a protocol, or action plan that describes what will be done in the study, how it will be conducted, and why each part of the study is necessary – including details such as the criteria for patient participation, the schedule of tests, procedures, and medications, and the length of the study. Additional Resource Information on clinical trials can be found at http://clinicaltrials.
All Clinical Trials are based on a set of rules called a protocol. A protocol describes the types of people who may participate in the trial; the schedule of tests, procedures, medications, dosages; and the length of the study. The factors that allow you to participate in a Clinical Trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criterions are used to identify appropriate candidates.
