There are many critical facts to consider before enrolling in a clinical study. The following are a few common terms used in clinical research.
Adverse Drug Reaction (ADR) – An adverse drug reaction is any harmful or unintended response to a drug.
Adverse event (AE) – An adverse event is any harmful or unintended effect, finding or symptom that may be possibly linked with the use of a medicine or treatment.
Assent – Assent is when a child agrees to participate in research. Federal law requires, when appropriate, for children to assent to participate in a study.
Blinding/Masking – Blinding/masking is when one or more parties to a clinical trial are not aware of the treatment assignment(s). Single blinding is when the subject is not told what treatment they received until after the trial ends. Double blinding is when the subject(s), investigator(s), monitor, and/or data analyst(s) will not know which treatment a participant received until the end of the trial. Blinding/masking is typically used when a placebo (inactive substance) or second drug is used in the study.
Clinical Protocol – The clinical trial protocol is a document that describes how a clinical trial will be conducted while also meeting scientific and ethical standards.
Clinical Trial/Study – A clinical trial/study helps determine if a drug or treatment works.
Compensation – Compensation is any money or value offered for participation in a study. Compensation does not include expenses such as travel, parking or time away from work, etc.
Compliance – Compliance means following all requirements related to the trial.
Confidentiality – Confidentiality means protecting information from disclosure to unauthorized individuals.
Disability – A disability is anything that majorly disrupts a person’s ability to complete normal life functions.
Guardian – A guardian is an individual legally authorized to give consent for a child’s medical care.
Human Subject – A human subject is any living individual enrolled in a research study.
Informed Consent –Informed consent is when the investigator or study team member discuss the study and review the informed consent document with the prospective subject and/or legal authorized representative; and they are provided sufficient opportunity to consider whether or not to participate in a study. Informed consent is usually documented by signing an informed consent document.
Institutional Review Board (IRB) – The Institutional Review Board is an independent committee made up of medical, scientific and non-scientific members who protect the rights and safety of human subjects involved in a clinical trial.
Intervention – A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines and noninvasive approaches, such as education or modifying diet and exercise.
Investigational New Drug (IND) Application – An application submitted to the U.S. Food and Drug Administration (FDA) by the sponsor to conduct an investigational drug trial. The FDA must approve the IND before the study can start enrolling participants.
Investigational Device Exemption (IDE) – An IDE is submitted to the FDA by the sponsor to conduct an investigational device trial. The FDA must approve the IDE before the study can start enrolling participants.
Investigational Product (IP) – An investigational product is an active ingredient or inactive ingredient (placebo) being tested or used in a clinical trial.
Investigator – An investigator is a person in charge of the conduct of the clinical trial. This person may also be called the principal investigator.
Legally Authorized Representative (LAR) – The legally authorized representative is the individual authorized under law to consent to a subject’s participation in the clinical trial.
Minor – A minor is a person under 18 years of age who is not married.
Minor Authorized to Consent – A minor authorized to consent is a person of at least 16 years of age.
Multi-center Trial – A multi-center trial is a clinical trial following a single protocol but carried out by more than one investigator at multiple sites.
Principal Investigator (PI) – A principal investigator is responsible for all aspects of the clinical study, including the protection of the rights and safety of each human subject.
Protected Health Information (PHI) – Private information about an individual that could possibly identify them and is protected by law.
Protocol – A protocol is the document that describes all elements of the clinical trial and details how it will be conducted.
Protocol Amendment – A protocol amendment is the written description of a change(s) to a protocol.
Qualified Bilingual Assistant – A qualified bilingual assistant is an employee or other credentialed person who can provide foreign language translation.
Randomization – Randomization is the process that uses chance to reduce bias in assigning trial subjects to treatment or control groups.
Regulatory Authorities – Regulatory authorities are those bodies that have the power to regulate clinical trials. For example, the FDA.
Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Serious Adverse Event (SAE) – A serious adverse event is any event that results in life-threatening situations, hospitalization, disability, incapacity, birth defect or death.
Sponsor – An individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial.
Sponsor-Investigator – An individual who is responsible for meeting the obligations of both the sponsor and the investigator.
Stipend – See Compensation.
Study Team Member - Any person who is authorized to assist the investigator with the conduct of the study.
Trial Site – The trial site is the location(s) of the clinical trial.
Witness – A witness is a person independent of the clinical trial who cannot be influenced by anyone involved with the clinical trial. The witness verifies that the information discussed in the informed consent process is consistent with the informed consent document.