A complication or side effect that may occur during the research study. An anticipated adverse event is known to occur from past experience with the treatment. An unanticipated adverse event is an unexpected complication. These events may or may not be related to participation in the research study, but are closely monitored and recorded by the principal investigator (PI).
A medical researcher in charge of carrying out a clinical trial's protocol. Researchers are usually doctors, nurses, pharmacists, or other healthcare professionals.
The 1991 agreement to cover all federally-sponsored research by a common set of regulations.
Declaration of Helsinki
A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964. The declaration addresses ethical issues for physicians conducting biomedical research involving human subjects. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.
The process used in research studies in which neither you nor your doctor will know if the medication you receive is the investigational drug or a placebo. This is done to ensure no bias occurs.
Food and Drug Administration (FDA)
The federal government agency that enforces laws on the manufacture, testing, and use of drugs and medical devices. In the United States, all prescription drugs and medical devices must be approved by the FDA before they can be used by the general public.
Good Clinical Practice (GCP)
An international ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. GCP insures that the data reported is credible and accurate, and that the subject's rights and confidentiality are protected.
Predetermined criteria that are established in order to select the appropriate participants for the study. The presence or absence of certain conditions, the medications, or physical characteristics that determine a subject's ability to participate in a given study.
The process by which a subject verifies his voluntary participation in a study. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternate therapies available, and the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.
Institutional Review Board (IRB)
A board of physicians, scientists, and non-medical persons, often from the community, who must review and approve all clinical research (and written informed consent documents), The board scrutinizes all trial activities including recruitment, advertising, and potential risks. The IRB also makes sure that FDA regulations are being followed in trials. Research may not commence without IRB approval.
Being researched. The FDA will allow certain drugs to be studied for a specific disease or condition, but not for general use. These are called investigational medications.
National Research Act
An act created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent.
As a result of the medical experimentation conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants
Office for Human Research Protection (OHRP)
A federal government agency that issues Assurances and oversees compliance of regulatory guidelines by research institutions.
A substance containing no active medication. Placebos are often used in clinical trials to compare with investigational medications.
Commonly referred to as the "P.I.", this person conducts the clinical research, and may have either designed the study or been chosen to help conduct it by a sponsor.
A written procedure describing, in detail, the steps to conduct a controlled study (usually a preclinical study or clinical trial) to ensure the collection of valid data.
The procedure to assign patients to treatment groups so that every person has an equal chance of being in any of the groups (like flipping a coin).
This is the primary location where the research is being conducted. This institution retains the ultimate responsibility for human subject regulation compliance.
The participants in a clinical research study. The individuals voluntarily agree to participate in the study. Research subjects, also referred to as human subjects have been more recently designated as research study participants.
The pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocols.
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