Glossary results: I
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
A document that describes the rights of the study participants and includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
1. A committee of physicians, statisticians, researchers, community advocates and others who ensure a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.
Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized (see Randomization) even if they never received the treatment.
The generic name of the precise intervention being studied.
Primary interventions being studied. Types of interventions are drug, gene transfer, vaccine, behavior, device or procedure.
A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
A document required in a clinical trial, along with the clinical trial protocol. It contains both clinical and nonclinical data pertaining to the new drug. The company sponsoring the trial provides a copy to each principal investigator before the trial begins.
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Information included in the Glossary is from Clinicaltrials.gov, which uses content from AIDSinfo, CenterWatch, Inc., ECRI, Eli Lilly and Company, MediStudy.com, Inc. and National Cancer Institute.