Guidance published by the ICH in the Federal Register on May 9, 1997 (62 FR 25692)
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(e)(5)]
Spouse, domestic partner or dependent children.
A stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
The pre-determined conditions of a clinical trial that allow or exclude participation. These criteria are factors such as age, gender, type and stage of a disease, previous treatment history, and/or other medical conditions.
Investigators withhold information from participants related to the specific purpose, nature, or other key aspect of the research.
Sponsor notifications to FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing a drug under its or investigators' INDs) which may include:
The identity of the research participant is or may readily be, ascertained by the investigator or associated with the information.
Information which either is labeled by name or other personal identifiers; or by virtue of sample size or other factors, be reasonably interpreted as referring to a particular private person.
A document that describes the rights of a study participant and provides 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.
Institution means any public or private entity, or department or agency (including federal, state and other agencies).
Individuals who:
Situations in which the University's beneficial relationship with corporate entities may place it in conflict with its responsibilities as a public institution of higher education. The conflict may involve equity interest in companies, receipt of significant financial donations from external entities, certain licensing situations and Board and other leadership positions held by University faculty or administrators.
A senior official named in the FWA who has the authority to commit the entire organization, as well as all of the components listed in the FWA, to a legally binding agreement. The Institutional Official (IO) also has the authority to assure compliance of the organization and all of its components to the Terms of the FWA. At the University, the IO is the Vice President of Research.
An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.
Procedures and policies that apply to research taking place outside the U.S. often differ from those set forth in the U.S. federal policies. U.S. federally funded research activities in a foreign country may be approved only if the ethical protections are equivalent to those in the U.S. This is also true for FDA approval of drugs/devices/biologics tested outside the United States.
A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes (45 CFR 46.102(f)). Interventions can also include noninvasive approaches such as surveys, education, and interviews.
In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product or "study drug" obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The purpose of the IB is to compile data relevant to studies of the study drug in human subjects gathered during preclinical and other clinical trials.
According to the Food and Drug Administration (FDA), an investigational device is a device, including a transitional device, that is the object of a [clinical] investigation involving one or more subjects to determine the safety or effectiveness of the device (21 CFR 812.3). Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
IDEs are exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations [21 CFR 812.20].
According to the Food and Drug Administration (FDA), investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous. (21 CFR 312.3)
Investigator is any WCM personnel, regardless of title or position, who is responsible for the design, conduct, or reporting of research.
Investigator includes, but is not limited to, the Principal Investigator(PI), Project Director (PD), Co-principal investigator (CO-PI), and may also include key personnel, a postdoctoral fellow, graduate student, trainee, staff member, collaborator, or consultant, depending on the person’s role in the research.
NOTE: For specific research projects funded by the U.S. Department of Energy (DOE), the relevant DOE program office may expand the definition of an investigator for Conflict of Interest disclosure purposes to include any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. This expansion will be noted in the applicable Funding Opportunity Announcement (FOA) and/or the terms and conditions of the awarding contract. The primary factor to be used in determining who is an investigator is based on the significance of the tasks assigned to the individual with regard to the design, conduct, and reporting of the Research and the degree of independence that individual may have in performing such Research-related tasks.
A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
Research that is initiated and conducted by an individual rather than a sponsor/pharmaceutical company. The investigator has the same responsibilities that a sponsor would have.
The review process for Full Board studies and, rarely, a few Expedited studies where the researcher renews their IRB approval once every 12 months (or more frequently as determined by the convened Full Board). 45 CFR 46.109(e) and 45 CFR 46.109(f)(1)
An Institutional Review Board (IRB) designated as the Reviewing IRB for human subject research as specified in an IRB Authorization Agreement, Cooperative Agreement, Memorandum of Understanding, or other contract between the University and an external institution. The IRB of Record assumes all of the IRB responsibilities for human research activities subject to the agreement.
