Investigational New Drug Application - The IND is the legal mechanism under which experimental drug research is performed in the United States (Ref. 21 CFR 312). An IND is submitted to the Food and Drug Administration in order to receive an exception from premarketing approval requirements so that experimental clinical trials may be conducted.
Use of a drug in a research study that meets the criteria outlined in the Code of Federal Regulations 21 CFR 312.2. See also COMMERCIAL DRUG.
The verification of a person’s willingness to participate in a research project. Prior to enrollment onto a clinical trial, researchers inform participants about all relevant study details. Participants are provided an informed consent document that details all important study information, including purpose, duration, risks, potential benefits, required procedures, and key contacts. Patients will be asked to sign this document if they agree to participate in the trial. The informed consent document is not a contract. Participation in the clinical trial is voluntary and the participant may withdraw from the trial at any time without penalty. The research team actively maintains informed consent throughout the trial by providing the participant with any new or developing information.
A university, hospital, or clinic. Institutions may be SWOG members, affiliates, or NCORP members (see related entries above and below). Institutions are also referred to as “sites.”
Any physician who assumes full responsibility for the treatment and evaluation of patients on research protocols as well as the integrity of the research data