Clinical Research Terminology Fundamentals Flashcards
Amendment
A change to an approved clinical protocol which significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. May also include administrative or minor changes, such as changes in company personnel or spelling errors.
Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
Biologic
Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.
Code of Federal Regulations (CFR)
A codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Case Report Form (CRF)
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
Clinical Research Associate or The Monitor (CRA)
The individual appointed by the sponsor, responsible for carrying out on-site monitoring, verifying data, and reporting on the progress of the trial.
Clinical Research Coordinator/Study Coordinator (CRC)
The individual responsible for conducting clinical trials under the supervision of the investigator.
Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
Control Group
The group of subjects in a controlled study that receives no treatment, a placebo, or a standard treatment.
Device (Medical Device)
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or the cure, treatment, or prevention of disease or is intended to affect the structure of any function of the body. A device does not achieve its primary intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
Drug
As designed by the FD&C Act, drugs are “articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals.”
Electronic Medical Record (EMR)
A collection of a subject’s medical information in electronic form.
Food and Drug Administration (FDA)
An agency of the U.S. government which oversees the study of investigational drugs and grants marketing approval for new drugs. Sometimes referred to as the agency.
Form FDA 1571
Investigational New Drug Application (IND)
Form FDA 1572
Statement of Investigator
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Health Information Portability and Accountability Act (HIPAA)
USA law that protects health insurance for workers when they change/lose their jobs and addresses the security and privacy of health data, and requires national standards for electronic healthcare transactions and national identifiers for providers, health plans, and employers.
Human Subject
An individual participating in research, either as a recipient of the test article or as a control. A subject may be either a healthy volunteer (or a patient).
Investigator’s Brochure (IB)
A collection of preclinical and clinical data about the investigational drug. Also referred to as Clinical Investigation Brochure or Investigational Drug Brochure.
Informed Consent (IC)
A process by which a subject voluntarily confirms his or her willingness to participate in a trial.
Investigational New Drug Application (IND)
An official proposal through which a sponsor obtains FDA approval of its plan to test a new drug in human clinical trials.
Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. ICH 1.33
Protocol
A formal written document which states the rationale, objectives, and statistical design of the trial.
Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial, but who does not actually conduct the investigation.
Sponsor-Investigator
An individual who both initiates and actually conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
