Clinical Research

Blinded trial - A trial in which the clinical research investigator and the patient do not know which of the discussed treatment options will be administered to that particular patient. The purpose of a blind trial is to be sure that expectations do not influence the outcome of the trial. The opposite of a blind trial is an "open label" study.

Clinical research investigator – This is usually a physician, but always a specialist trained in the management of clinical research.

Clinical research coordinator - This is a health care professional, often a nurse, who assists the investigator in managing the trial.

Consent form – Contains all relevant study information explained in lay terms and documents voluntary participation of subject. Presented to and signed by subject.

Informed consent – A discussion required by the FDA to take place before a participant can enroll in a trial. It is an information exchange that includes subject recruitment materials, verbal instruction, written materials, question and answer sessions and signature documenting consent with date.

Institutional Review Board (IRB) - The committee which regulates the way in which Guthrie clinical trial research may be conducted . The IRB reviews research and consent forms to determine if the rights and welfare of subjects are protected.

Investigational materials - A drug or device not yet approved by the FDA.

Open label study - A trial in which the clinical research investigator and the patient know which of the discussed treatment options will be administered to that particular patient.

Placebo – A drug that will have no effect or medical activity, used in a blind trial to ensure that expectations of outcome do not influence the clinical result.

Sponsor – A company, a research entity or individual who wishes to investigate the effectiveness of a new treatment and provides the funding required to conduct the investigation.

Subject – A patient or healthy individual who volunteers to participate in a clinical trial, or who will be participating in a research study. Also called a participant.