Clinical Trial Terminologies

Abbreviated protocol A summary protocol containing brief information about the study which may be used as a concept document to get internal approval to start the planning phase of a study. It may also be used as an initial discussion document for a meeting with a prospective Principal Investigator.

Action Letter The letter from regulatory authority to the sponsor company, in response to an application submission to do a clinical study. It may be an “Approval letter” with some minor modifications recommended or a “Non Approval Letter” indicating that significant changes will be needed before the application can be considered.

Admission criteria Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study.

Adverse Drug Reaction (ADR) In case of approved pharmaceutical products: A noxious and unintended response at doses normally used or tested in human. In case of new unregistered pharmaceutical products ( or those products which are not yet approved for the medical condition where they are being tested): A noxious and unintended response at any dose(s). In clinical studies, an untoward medical occurrence seemingly caused by overdosing, abuse / dependence and interactions with other medicinal products is also considered as an ADR.

Adverse Event/ Experience (AE) Any untoward medical occurrence (including a symptom/ disease or an abnormal laboratory finding) during treatment with a pharmaceutical product in a patient or a human volunteer that does not necessarily have a relationship with the treatment being given. When an Adverse Event has been assessed and there is reasonable grounds for suspicion that it is causally related to the investigational product(s) established, it must be considered as an Adverse Drug Reaction.

Aim of Study The objective of the clinical study. Each study should only have one main objective. If additional objectives are required then a separate study should be undertaken for each objective. Amendment A document that describes changes or additions to an Investigational New Drug (IND) filed with the Regulatory Authority a supplement to a pending New Drug Application (NDA) such as a safety or data update or changes to a existing protocol.

Ascending Doses Subjects are dosed with increasingly higher doses of a drug until the maximum tolerated dose is reached. This usually applies to a Phase- I study. Archiving of Clinical Study Data According to GCP Guidelines, clinical study data should be stored for at least five years by the investigator/ CRO and for the lifetime of the drug by the pharmaceutical company.

Assent Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Assurance A formal written, binding commitment that is submitted to a Regulatory Agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.

Audit of a Study A systematic verification of the study, carried out by persons not directly involved, such as: Study related activities to determine consistency with the Protocol. Studies data to ensure that there are no contradictions on Source Documents. The audit should also compare data on the Source Documents with the interim or final report. Compliance with the adopted SOPs.

Baseline Measurements that are taken at the beginning of a study to serve as a reference for subsequent measurements or observations. Belmont Report A statement of basic ethical principles governing research involving human subjects issued by the U.S. National Commission for the Protection of Human Subjects in Bias When a point of view prevents impartial judgment on issue relating to the subject of that point of view. In clinical studies, this is controlled by blinding and randomization.

Case History Record The hospital chart or medical office file containing medical and demographic information on the study subject. Causality The relationship between the adverse experience and the test agent in terms defined in the protocol.

Case Report/Record Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH) A document designed in consonance with the Protocol, to record data and other information on each study subject. The Case Record form should be in such a form and format that allows accurate input, presentation, verification, audit and inspection of the recorded data. A CRF may be in printed or electronic format.

Certificate of Destruction All returned and unused medication has to be destroyed at the end of the study. Normally this material is returned to the sponsor together with the appropriate inventory. Certificate of destruction is issued which lists the drugs and the quantity destroyed on a given date. This certificate is filed in the clinical study Master File.

Clean database (or file) One from which errors have been eliminated and in which measurements and other values are provided in the same units. Clinical research associate (CRA) Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study. At some (primarily academic) sites, clinical research coordinators are called CRAs.

Clinical research coordinator (CRC) Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit. Synonyms: trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse, protocol nurse.

Clinical trial Systematic study of a test article (treatment, drug, device) In one or more human subjects. Synonyms: clinical study, clinical investigation. Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity. (ICH)

Contract research organization (CRO) A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions. (ICH) Control group The group of subjects in a controlled study that receives no treatment, a standard treatment, or a placebo.

Controlled study A study in which a test article is compared with a treatment that has known effects. The control group may receive no treatment, standard treatment, or placebo.

Database Data stored in computer form for retrieval, processing, and/or analysis. Data monitoring Process by which case report forms are examined for completeness, consistency, and accuracy.

Declaration of Helsinki A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. It was originally adopted by the 18th World Medical Assembly (Helsinki, Finland,1964); Demographic data Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.

Double-blind study A study in which neither the subject(s) nor the investigator(s) know what treatment a subject is receiving. Ethics Committee An independent review board or committee comprising of medical, scientific and non-medical/non-scientific members, whose responsibility is to verify the protection of the rights, safety and wellbeing of human subjects involved in the study.

Food and Drug Administration (FDA) The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.

Informed consent A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.

Impartial witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject. (ICH)

Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. (ICH). Monitor Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol.

Multicenter trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. New Drug Application (NDA) An application to FDA for a license to market a new drug in the United States.

Nuremberg Code Code of ethics for conducting human medical research set forth in Open study A trial in which subjects and investigators know which product each subject is receiving; opposite of double blind study.

Pharmacovigilance Term used for adverse event monitoring and reporting in some countries. Prospective study Investigation in which a group of subjects is recruited and monitored in accordance with criteria described in a protocol.

Randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH)

Source documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). (ICH)

Sub investigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial related decisions (e.g., associates, residents, research fellows). (ICH)

Subject/trial subject An individual who participates in a clinical trial, either as recipient of the investigational product(s) or as a control. (ICH) Subject identification code A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in place of subject’s name when the investigator reports adverse events and/or other trial- related data. (ICH)

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