Clinical Trial Glossary
Clinical Trial Glossary Final - FDA
Clinical Trials: What Patients Need to Know > Glossary of Terms - FDA
Adverse Event - drug reaction is also known as a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life- threatening, result in hospitalization or death, or are birth defects.
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Boxed Warning - This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.
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Cardiovascular disease– also called heart disease is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both.
CDRH– (Center for Devices and Radiological Health) assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
ClinicalTrials.Gov- is an online registry of clinical trials that are being conducted around the world. ClinicalTrials.gov is operated by the National Library of Medicine at the National Institutes of Health and can be accessed by anyone who has access to the internet.
Comparison– To learn more, researchers compare results from patients in the experimental groups with results from patients in the control groups.
Compassionate Use - Expanded access, also called “compassionate use,” provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Investigational drugs and devices have not yet been approved by the FDA and they have not been proven to be safe and effective. Therefore, they may be effective in the treatment of a condition, or they may not. It is important to remember that the drug/biologic/medical device may have unexpected serious side effects and that patients need to consider all the possible risks when seeking access to an investigational medical product.
Clinical Trials Glossary of CommonlyUsed Terms
The ability of a drug or treatment to produce a beneficial result. A drug demonstrates efficacy if it is effective at the dose tested against the illness for which it is prescribed.Eligibility criteriaThe key standards that people who want to participate in a clinical study must meet or the characteristics they must have.
criteria include both inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
The number of participants in a clinical study.
Exclusion and inclusion criteria
The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, pregnancy status, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants to ensure the integrity of the study and to keep them safe.
Health Insurance Portability and Accountability Act of 1996 (HIPAA)HIPAA established national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addresses the security and privacy of health data. All clinical trial data and activities performed by covered entities must comply with HIPAA regulations.
CDISC Clinical Research Glossary
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary]
Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharm-aceutical company). [ICH E6 Glossary]
audit report. A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary]
audit trail. A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI]
back translation (natural language).
The process of translating a document that was translated from one language to another back to the original language. Used to ensure that consent forms, surveys, and other clinical trial documents will be clear and accurate in the translated form.
Information pertinent to the understanding of a protocol. NOTE: Examples include investigator brochure, literature review, history, rationale, or other documentation that places a study in context or presents critical features. [PR Project]
Trial in which a particular type of subject is equally represented in each study group.
NIA Glossary of Clinical Research Terms
Clinical Research – NIH defines clinical research as:
Clinical Trial – The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, nutritional supplements, surgical intervention, or devices). Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.