Clinical Trial Glossary
- Adverse Drug Reaction
- Adverse Event
- Bioavailability Study
- Bioequivalence Study
- Case Report Form
- Certified Research Coordinator
- Clinical Investigation
- Clinical Research
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Study Materials
- Clinical Trial/Study
- Consent Forms
- Control Group
- Controlled Study
- Crossover Study
- Declaration of Helsinki
- Demographic Data
- Dosage Regimen
- Drug Product
- Effective Dose
- Ethics Committee
- Exclusion Criteria
- Experimental Drug
- Food and Drug Administration (FDA)
- Food Drug and Cosmetic Act
- Generic Drug
- Good Clinical Practice
- Half-Life of a Drug
- Healthy Volunteer
- Human Pharmacology
- Human Subject
- ICH-International Conference of Harmonization
- Inclusion Criteria
- Informed Consent
- Institutional Review Board
- Investigational New Drug Application
- Investigational Product
- Investigator’s Brochure
- Marketing Studies
- MedWatch Program
- Multicenter Study
- Multicenter Trial
- National Research Act
- National Institutes of Health
- New Drug Application
- Nuremberg Code
- Off Label
- Open-Label Study
- Orphan Drug
- Parallel Group Study
- Pharmacokinetic Study
- Phase I Study
- Phase I Unit
- Phase II Study
- Phase III Study
- Phase IV Study
- Pilot Study
- Pivotal Study
- Pre-Clinical Testing
- Protocol Amendment
- Quality Assurance
- Random Allocation
- Recruitment Period
- Regulatory Affairs
- Research Team
- Run-in Period of Study
- Safety Reports
- Serious Adverse Event
- Side Effect
- Single Blind Study
- Source Data
- Standard Operating Procedure
- Standard Treatment
- Study End Point
- Subject/Study Subject
- Washout Period
Adverse Drug Reaction (ADR)
Any unintended reaction to a new treatment or drug when taken at doses typically used for diagnosis, therapy of disease, prophylaxis or for modification of physiological function, which may occur suddenly or develop over time.
Adverse Event (AE)
When a participant or patient has an undesirable or negative experience associated with a drug or treatment during a clinical trial. Adverse events can include the worsening of a pre-existing condition or the presence of symptoms that were previously unnoticed.
A study which tests the same drug manufactured by two different companies to show that the two drugs are bioequivalent (the two drugs do not significantly differ in similar studies under similar conditions with the same dosage).
A procedure in which one or more parties in a clinical trial are unaware of the treatment assignments in order to decrease biases and avoid the placebo effect. See also, Single Blind and Double Blind.
Case Report Form (CRF)
Certified Research Coordinator (CCRC)
The study of drugs or treatments in human subjects that can be separated into therapeutic (where personal benefit is expected by the subject) and nontherapeutic (where the research is conducted to advance knowledge without the expectation of providing any benefit to the subject).
Clinical Research Associate (CRA)
Clinical Research Coordinator (CRC)
Clinical Study Materials
A systematic study used to evaluate a drug, treatment or device in one or more human subjects in the treatment, prevention or diagnosis of a disease or condition. This investigation is used to determine or confirm the clinical, pharmacological, pharmacokinetic and/or other pharmacodynamic effects of the investigational products, as well as identify any adverse reactions to determine their safety and efficacy.
A document that outlines all the potential risks, benefits and relevant information about a clinical study to the volunteer or participant. This document also details the involved parties’ rights and responsibilities. This document is signed by the volunteer/participant.
The group of individuals in a clinical study who do not receive the new treatment or drug, but instead are administered no treatment, an existing treatment or placebo. The control group is the standard by which experimental observations are measured and evaluated.
A study in which a new drug or treatment is tested against a treatment with known effects. One group receives the new treatment, while the other group receives no treatment, a standard treatment or a placebo.
Declaration of Helsinki
The international standard of guidelines for the protection of clinical trial participants’ rights, adopted by the 18th World Medial Assembly in 1964. These basic principles are designed to guide physicians conducting biomedical research involving human subjects.
The schedule of doses, including the number of doses given in a time period; the elapsed time between each administered dose, or the time at which the doses are given; and the amount of medicine administered at each dosing time.
A clinical study in which neither the investigators nor the participants are aware of which treatment (the new treatment vs. the control) a subject is receiving as to produce objective results and reduce any potential biases from any involved parties.
A substance (other than food) used in the diagnosis, treatment, cure or prevention of disease; used to enhance mental or physical well-being; or used to affect the function or structure of the body in humans or animals.
Food and Drug Administration (FDA)
The United States regulatory authority within the Department of Health and Human Services responsible for enforcing the safety and efficacy of all drugs, medical devices, biologics and vaccines and granting IND and NDA approvals.
Food Drug and Cosmetic Act (FD & C Act)
A drug with the same molecular structure and active ingredient, but not necessarily the same inactive ingredients, as a brand-name drug. A generic drug can only be marketed after the original drug’s patent has expired and typically costs less than the proprietary brand.
Good Clinical Practice (GCP)
Half-Life of a Drug
ICH-International Conference of Harmonization
The patient’s confirmation of his or her willingness to participate in a clinical trial, along with written, signed and dated documentation. This verification is requested only after all key aspects of the clinical trial have been explained objectively by doctors and nurses.
Institutional Review Board (IRB)
An independent group of both medical and non-medical professionals who ensures a clinical study’s safety and efficacy for human participation. The IRB ensures that the clinical trial is ethical, that the rights of subjects are protected and that the study complies with the FDA’s regulations.
Investigational New Drug Application (IND)
An active ingredient or placebo in pharmaceutical form being tested in a clinical trial, which includes a marketed product used in a dissimilar manner than the approved form, when used for an unapproved indication or when used to acquire more information about an approved use.
Studies (most commonly Phase IV studies and some Phase III studies) which are executed to deliver clinical trial data to promote the product in the marketplace after the drug has been granted a license.
FDA program designed to monitor adverse events (AE) from drugs marketed in the U.S. through the online database known as the Adverse Event Reporting System (AERS). With MedWatch, health professionals and consumers can send adverse event reports voluntarily to the FDA. Drug manufacturers are obliged by regulations to report all AEs brought to their attention. The fundamental goal of AERS is to provide the tools for storing and analyzing safety reports to improve public health.
Person employed by the sponsor or CRO who verifies that a clinical study is being conducted in accordance with the protocol by assisting with the planning and initiation of a study and reviewing reports to assess the conduct of studies, among other duties. See also, CRA.
The act of supervising a clinical study, ensuring all aspects of the trial are conducted as stated in the clinical protocol, standard operating procedures, good clinical practice and by regulatory requirements.
National Research Act
An act that created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 to supervise and control the use of human experimentation in medicine and required the review of studies and participant’s protection by informed consent.
National Institutes of Health (NIH)
New Drug Application (NDA)
A request from the manufacturer of a drug to the FDA for a license to market a new drug in the U.S. Within this application, a comprehensive collection of all information about the new drug that was compiled in the clinical trial must be presented.
An FDA category which refers to drugs and treatments for rare diseases and conditions, or those which affect less than 200,000 people in the U.S. Orphan drugs have little financial incentive because they will help such a small population of people, so the U.S. government offers other incentives to drug companies for the development of these drugs.
Parallel Group Study (Trial)
A study in which two or more treatments are compared by randomly assigning participants to one of two treatment groups, which will receive the allocated medication throughout the duration of the study.
Phase I Study
Phase I studies are conducted on healthy volunteers to establish the effects of a new drug in humans. These initial studies are conducted to determine the safety and tolerability of a drug, as well as the drug’s toxicity, absorption, distribution and metabolism.
Phase I Unit
Phase II Study
Phase III Study
Phase III studies are large, multicenter studies of afflicted patients which test the new drug in comparison with a placebo or the standard therapy most commonly used to treat the condition or disease. Phase III studies gather additional information to further evaluate the efficacy and safety of a new drug.
Phase IV Study
Phase IV studies are post-marketing studies conducted to gain additional information about a drug’s safety and efficacy and to compare the drug to competitors in the market – after the drug has been approved by the FDA.
A controlled, randomized study conducted to good clinical practices and subjected to intense monitoring to ensure its validity in order to provide critical information to authorities about the efficacy and safety of a new drug.
A document that sets forth the objective(s), design, organization, statistical considerations and methodology for a clinical trial. A protocol must be approved by an IRB before the study can be conducted.
Run-in Period of Study
The period of time used to take patients off their existing medications in order to prepare them to be treated with a new drug. This may be accomplished through the administration of a placebo for up to two weeks.
Serious Adverse Event (SAE)
Single Blind Study
All information contained in original records and certified copies (source documentation) of findings, observations or other activities in a clinical trial mandated for the reconstruction and evaluation of the study.
Standard Operating Procedure (SOP)
Study End Point
The period of time in a clinical trial when patients are given a placebo or no drug at all to eliminate the effects of the first treatment before starting the second active treatment.