A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.
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A case report is one in which three or fewer records are accessed. Case reports do not meet the definition for human subjects research and do not require submissions to the IRB if the project meets the following criteria:
Nothing was done to the patient(s) with prior research intent. The…A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors.
Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.
Centers for Disease Control and Prevention; an agency within the Public Health Service, Department of Health and Human Services.
A cell-line refers to a collection of a participant's white blood cells that are kept alive, usually stored in a freezer. Researchers are able to study these cells repeatedly for many years.
A document issued by NIH for certain types of research that provides additional protection of data from legal subpoena. The Certificate provides protection against compelled disclosure of identifying information or other identifying characteristics of a research participant enrolled in…
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted.
Use of a drug or medical device other than the use of an approved drug or medical device in the course of medical practice, when data will be gathered, submitted to, or held for inspection by the FDA in support of an FDA marketing permit for a food, including a dietary supplement that bears a…
An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.
Any experiment that involves a test article and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB.
A research study in which one or more human subjects are prospectively assigned to one or more interventions interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes…
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is…
The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
The U.S. Department of Health and Human Services (HHS) issues and enforces rules…
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished…
A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.
The real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships. A conflict of interest occurs when individuals involved with the conduct, reporting, oversight,…
Commonly referred to as the "ICF" or "Informed Consent Form". These are the documents presented to a subject or parent/guardian prior to beginning a study. Most studies will have this document submitted with the proposal, unless requesting a Waiver. The IRB has provided a template on the web…
A pattern of repeated actions or omissions to act that suggests a future likelihood of reoccurrence and that indicates a deficiency in the ability or willingness to comply with Federal regulations or the policy, requirements, and determinations of the IRB governing human subject research.
The group of individuals in a clinical trial assigned to a comparison intervention.
A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a historical…
Control subjects (followed at some time in the past or for whom data are available through records) who are used for comparison with subjects being treated concurrently. The study is considered historically controlled when the present condition of subjects is compared with their own condition on…
A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).
COPPA imposes certain requirements on operators of websites or online services directed to children under 13 years of age, and on operators of other websites or online services that have actual knowledge that they are collecting personal information online from a child under 13 years of age.…
Health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses (45 CFR 160.103). Covered Entities must comply with HIPAA regulations.
Several areas within the…
Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later…