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Terms Abbrv. Definition Remarks
Effective Dose The dose of an investigational agent that produces the outcome
considered “effective” as defined in the study protocol. This could mean a cure of the disease in question or the mitigation of symptoms.
Effectiveness Whether a drug achieves its desired effect in the real world.
Efficacy The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. Efficacy is measured by evaluating the clinical and statistical results of clinical tests. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. (in regards to drug or treatment)
Electronic Data Capture EDC The process of collecting clinical trial data into a permanent electronic form. NOTE: “Permanent” in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail.
Eligibility Criteria Summary criteria for participant selection; includes Inclusion and Exclusion criteria. Refer to Exclusion/Inclusion Criteria
Emergency Use The single use of an investigational drug in a life-threatening or severely debilitating situation for a specific individual when there is not sufficient time to obtain prospective IRB approval before treatment.
Empirical Based on experimental data, not on a theory
Endpoint Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
Enrolling Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.
Epidemiology The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.
Equipoise A state of true uncertainty on the part of a researcher about which
treatment (investigational or standard) will achieve a better result.
Essential Documents Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Ethics Committee An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants. Also referred as Institutional Review Board (IRB)
European Medicines Agency EMEA The European regulatory agency responsible for the scientific evaluation of applications for European marketing authorization for medicinal products (centralized procedure). EMEA’s main mission is to protect and promote public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
Exclusion/ 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.
Expanded Access Refers to any of the regulatory authority procedures, such as compassionate use, parallel track, and treatment Investigational New Drug Application (IND) that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
Experimental/ Investigational Drug A drug that has been authorized for use in a clinical trial but has not been granted marketing approval as a treatment for a particular use.
FDA Form 1572 A list of commitments and requirements by the FDA for each investigator performing drug/biologics studies. Also referred to as a statement of the investigator.
First Subject Screened First subject who signs the informed consent form and is screened for potential enrollment and randomization into a study, but has not yet been determined to meet the inclusion/ exclusion criteria for the trial.
First Subject Treated First subject who receives the test article or placebo in a clinical trial.
First-in-Human Study The first Phase I study in which the test product is administered to human beings.
First-in-Human/Man Study A clinical trial where a medical procedure or medicinal product, previously developed and assessed through laboratory model or animal testing, or through mathematical modeling is tested on human subjects for the first time
Food and Drug Administration FDA The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. The FDA also works with the blood banking industry to safeguard the nation’s blood supply.
Food Drug and Cosmetic Act (FD & C Act ) States only drugs, biologics and devices proven safe and effective can be marketed.
Formulation The mixture of chemicals and/or biological substances and excipients used to prepare dosage forms.
Generic Drugs A medicine with the same active ingredient, but not necessarily the same inactive ingredients, as a brand-name drug. A generic drug may be marketed only after the original drug’s patent has expired
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.
Good Manufacturing Practice GMP A set of principles and procedures that assures that products are consistently produced and controlled in conformity with quality standards appropriate for their intended use and as required by the product specification.
Guardian An individual who is legally appointed by a court under applicable state law to make personal and financial decisions for the care and management of an incapacitated person. State laws differ on whether or not a guardian can consent to an individual’s participation in research.
Healthcare Provider 1. One who directly or indirectly administers interventions that are designed to improve the physical or emotional status of patients. 2. A person licensed, certified or otherwise authorized or permitted by law to administer health care in the ordinary course of business or practice of a profession, including a health care facility.
Healthy Volunteer Subject (not a patient) in a clinical trial. NOTE: Usually healthy volunteers serve as subjects in Phase I trials.
Herbal/Animal Medicinal Products Plant/animal-derived materials or products with therapeutic or other human health benefits which contain either raw or processed ingredients from one or more plants/ animals
Human Subject A patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction.
Huriet Law France’s regulations covering the initiation and conduct of clinical trials.
Hypothesis A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.