The Protocol: The trial protocol is basically the rulebook for the trial, which describes what the research question is; clearly identifies the population of patients to be included in the study; and describes exactly how the treatment is to be given to eligible patients. Any physician involved in the study would have a copy of the protocol, and would have to adhere to all of the rules and procedures in it. More info on trial protocols

The Informed Consent: Each patient who considers taking part in a clinical trial must provide informed consent. Taking part in a clinical trial is voluntary, and patients who are eligible for a trial may choose to decline participation at any time before or during enrolment in a trial. To help a patient understand what is involved in a specific clinical trial, a physician uses a document, called an informed consent document, which tells the patient why the study is being done, what is involved, what risks and benefits might occur, what other options there are, what their rights are, how their confidentiality is maintained, and who they can talk to for more information before or during the study. There is a page for signatures, and if an individual chooses to participate in the study, they must sign this page. Usually the doctor and a witness not involved in the clinical trial would also sign this page at that time, and then any tests necessary to ensure that the patient is eligible to enter the study would be organized for them. The study treatment usually follows soon after. The patient is given a signed copy of the informed consent to refer to.

The informed consent is usually about 8-12 pages long, but may be shorter or longer, depending on the complexity of the information. More info on trial consents