Adverse Drug Reaction
An unintended reaction to a drug taken at normal doses.
Adverse Event (AE)
Any untoward occurrence (physical, psychological, social or economic) in a human subject participating in research, it does not necessarily have a causal relationship to the investigation treatment.
Doing no harm. Maximizing benefits while minimizing risks.
A virus, toxin, antitoxin, blood product, therapeutic serum or similar material for the prevention, treatment or cure of disease or injury in humans.
Any technique that uses living organisms or substances from living organisms, biological systems or processes to make or modify a product or process, to change plants or animals, or to develop microorganisms for specific uses.
The process through which study subjects, the investigator and/or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects.
Case Report Form (CRF)
A record of pertinent information collected on each subject during a clinical trial, based on the protocol.
Clinical Investigator (CI)
An individual who conducts a clinical investigation.
Clinical Trial (clinical study, clinical investigation)
Any experiment that involves a test article (drug, device, biologic) and one or more human subjects.
Clinical Research Associate (CRA)
The sponsor monitor who visits sites periodically during a study to monitor the data and assess progress.
Clinical Research Coordinator (CRC) (Study coordinator)
The person at an investigational site who manages the daily operations of a clinical investigation and is under the direction of the Principal Investigator.
Clinical Research organization (CRO)
CRO – A person or an organization contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.
A group of subjects who are not treated with the investigational product. This group is used as a comparison to the treatment group
The process of handling the data generated and collected during a clinical trial, usually including data entry and database management.
The characteristics of study subjects, including age, sex, medical history and other information relevant to the study.
An instrument, apparatus, implement, machine, contrivance, implant, in vitro (in a test tube, etc. rather than in the body) reagent or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
The design of a study in which neither the investigator nor the subject knows which treatment the subject is receiving.
An article (other than food) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.
A test product’s ability to produce a beneficial effect on the duration or course of a disease.
The United States Food and Drug Administration.
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. They are meant to protect the safety, rights and welfare of the subjects in addition to ensuring the accuracy of the data collected during the trial.
An individual who participates in research, either as a recipient of the test article or as a control. A subject may be either a healthy subject or a patient.
Inclusion and Exclusion Criteria
The characteristics that must be present (inclusion) or absent (exclusion) in order for a subject to qualify for a clinical trial, as per the protocol for the trial.
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.
Institutional Review Board (IRB)
Any board, committee, or group formally designated to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research.
Investigator (Clinical Investigator [CI], Principal investigator (PI])
An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is dispensed, or, in the case of an investigation conducted by a team of individuals, is the responsible leader of that team.
A compilation of all information known to date about the test product, including chemistry and formulation information and preclinical and clinical data. It is updated at least annually. Once the product is marketed, it is replaced by the labeling (package insert) for the product.
Investigational New Drug
A new drug or biologic that is used in a clinical investigation.
Investigational New Drug Application (IND)
The application to start clinical testing of a new drug, biologic or device in humans.
In Vitro Testing
Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.
The determination of the IRB that the clinical investigation has been reviewed and may be conducted within the constraints set by the IRB and applicable regulations.
Legally Authorized Representative (LAR)
An individual or judicial or other body authorized under applicable law to consent on behalf of a potential subject to the subject’s participation in research.
Medical Monitor (Sponsor Medical Monitor)
The physician for the sponsor who is responsible for the clinical investigation of a test product.
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or in the performance of routine physical or psychological examinations or tests.
New Drug Application (NDA)
The marketing application for a new drug submitted to the FDA. The NDA contains all the non-clinical, clinical, pharmacological, pharmacokinetic and stability data required by the FDA.
Open Label Study
A study in which the subjects and the investigator are aware of the drug/device that is being administered.
An inactive substance designed to resemble the drug being tested.
Studies conducted on animals to determine that the drug is safe to use in studies on humans.
A document that describes the objective(s), design, methodology, statistical consideration, and organization of a clinical trial.
Systems and procedures designed to ensure that a study is being preformed in accordance with Good Clinical Practice (GCP) guidelines and that the data being generated are accurate.
A method in which study subjects are randomly assigned to treatment groups. It helps to reduce bias in a trial by ensuring that there is no pattern in the way subjects are assigned to treatment groups.
Serious Adverse Event (SAE)
Any untoward medical occurrence in a drug study that results in death, is life-threatening, requires hospitalization (or a prolongation of hospitalization in a patient who is already hospitalized), results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of performance of a specific function. SOPs ensure that research is carried out in a consistent and efficient manner.
Study Coordinator (Clinical Research Coordinator)
The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator or study coordinator.
Any individual member of the clinical trial team designated and supervised by the Principal Investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions.
Any drug, biologic, or device being tested for use in humans.
Problem involving risks to human subjects participating in a clinical research study, e.g., breach of confidentiality, incorrect labeling of study drug. These need to be collected and reported.