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Terms Abbrv. Definition Remarks
Adverse Drug Reaction ADR All noxious and unintended responses to a medicinal product related to any dose should be considered as adverse drug reaction.
Adverse Reaction / Adverse Event AE Also known as side effects, adverse reactions include any undesired actions or effects of the experimental drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side
effects.
Advocacy and Support Group Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.
Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational product.
Approval A drug, device or biologic must be approved by a country’s regulatory
agency before it can be marketed. The approval process involves several steps including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) in the United States or Marketing Authorization Application (MAA) in Europe by the manufacturer, regulatory agency review of the application, and agency approval/rejection of application.
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, institution, Good Clinical Practice (GCP), and applicable regulatory requirement. in relation to Institutional Review Board (IRB)
Approved Drugs In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
In Malaysia, new drug application is to be submitted to the Drug Control Authority (DCA) http://www.bpfk.gov.my
Arm Any of the treatment groups in a randomized trial. Most randomized trials have two “arms,” but some have three “arms,” or even more.
Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the date were recorded analyzed and accurately reported according to the GCP and applicable regulatory requirement.
Audit Certificate A declaration of confirmation by the auditor that an audit has taken place
Audit Report A written evaluation by the sponsor’s auditor of the results of the audit.
Audit Trail Documentation that allows reconstruction of the course of events
Baseline Baseline information is gathered at the beginning of a study from which variations found in the study are measured. Baseline can also be described as a known value or quantity with which an unknown is compared when measured or assessed. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.
Baseline Imbalance Systematic error in creating intervention groups, such that they differ with respect to prognosis. That is, the groups differ in measured or unmeasured baseline characteristics because of the way
participants were selected or assigned. NOTE: Also used to mean that the participants are not representative of the population of all possible participants.
Bayesian Statistics Statistical approach named for Thomas Bayes (1701–1761) that has among its features giving a subjective interpretation to probability, accepting the idea that it is possible to talk about the probability of hypotheses being true and of parameters having particular values.
Belmont Report A statement of basic ethical principles that should govern research involving human participants issued by the National Commission for the Protection of Human Subjects in 1978.
Beta Error Probability of showing no significant difference when a true difference exists; a false acceptance of the null hypothesis.
Bias When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization
Bioanalytical Analysis Methods for quantitative measurement of a drug, drug metabolites, or chemicals in biological fluids.
Blind/ Blinded/ Blinding/ Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-binding usually refers to subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and in some cases, data analyst(s) being unaware of the treatment assignments. Extension of blinding to the investigator(s) are so that their patient observations are less likely to be biased by the awareness of the treatment the patient is receiving.
Case Control Study A scientific study that compares a group of people with a disease (such as leukemia) to a similar group of people without that disease. This type of study compares the levels of exposure (for example, radiation or chemical) each group had before appearance of the disease. Centers for Disease Control and Prevention. NIOSH Energy-Related Health Research Program, Glossary. Available at: http://www.cdc.gov/niosh/2001-133o.html.
Case History An adequate and accurate record prepared and maintained by an investigator that records all observations and other data pertinent to the investigation on each individual administered the investigational drug (device or other therapy) or employed as a control in the investigation. NOTE: Case histories include the case report forms and supporting data including, for example, signed and dated consent
forms and medical records including, for example, progress notes of the
physician, the individual’s hospital chart(s), and the nurses’ notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study
Applied Clinical Trials http://www.cdisc.org/glossary/clinicalterminologyv4.pdf
Case Report Form CRF A printed, optical, or electronic document designed to record all the protocol required information to be reported to the sponsor on each trial subject.
Case Reports Tabulation CRT In a paper submission, listings of data that may be organized by domain (type of data) or by subject. Applied Clinical Trials http://www.cdisc.org/glossary/clinicalterminologyv4.pdf
Certified Clinical Research Coordinator CCRC CRC with >2 years experience and with certification earned by passing required program and exam. Centrewatch
Clinical Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.
Clinical Endpoint/ Endpoint Overall outcome that the protocol is designed to evaluate.
Clinical Investigation A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product’s benefits relative to its risks. Centrewatch
Clinical Investigator A medical researcher in charge of carrying out a clinical trial’s protocol. Association of Clinical Research Organizations. Glossary of Clinical Trial Terms. Available at: http://www.acrohealth.org/glossary.php.
Clinical Research Associate CRA Person employed by the study sponsor or clinical research coordinator to monitor a clinical trial at one or more participating sites. The CRA is responsible for ensuring all clinical studies are conducted according to study protocol, within regulations and ICH guidelines. Clinical Data Interchange Standards Consortium. Glossary of Terms. Available at: http://www.cdisc.org/glossary/V6_Glossary2007.pdf.
Clinical Research Coordinator CRC Site administrator for the clinical trial who is responsible for coordinate administrative activities between field and home offices staff, such as the collection of essential documents, distribution of supplies and site selection. Also called research, study or health care coordinator, data manager, research nurse or protocol nurse West Coast Clinical Trials. Glossary. Available at: http://www.wcctrials.com/glossary.HTM.
Clinical Research Organization CRO A person or an organization (commercial, academic, or other) contracted by a research and development organization (sponsor) to perform one or more of a sponsor’s trial-related duties and functions
Clinical Study Materials Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator.
Clinical Trial Agreement CTA A written and legally binding agreement between the involved parties. It sets out arrangements on delegation and distribution of tasks and obligations and includes the protocol and study budget as appropriate. The CTA should be reviewed by the legal department and signed by an organizational official who has been explicitly delegated with research contracting authority.
Clinical trial Certificate CTC now incorporated in CTA www.tmn.ac.uk
Clinical Trial Exemption CTX An Approval by the Drug Control Authority (DCA) authorizing the applicant to manufacture any local product for the purpose of clinical trial.
Clinical Trial Import License CTIL A license in Form 4 in the schedule of The Control of drugs and Cosmetics Regulations of 1984, authorizing the licensee to import any product for the purposes of clinical trials, notwithstanding that the product is not a registered product.
Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic, diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. See the ICH Guideline for Structure and Content of Clinical Study Reports
Clinical Trial/Study/Research Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify adverse reactions to an investigational product(s) and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The term Clinical trial and clinical study are synonymous
Code of Federal Regulations CFR The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
Cohort In epidemiology, a group of individuals with some characteristics in common.
Collaborative Group A group of clinicians collaborating in a clinical trial www.tmn.ac.uk
Collaborator Clinician collaborating in a clinical trial www.tmn.ac.uk
Combination Product 1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit. 3. A product that is packaged separately but is used only with another product
Common Technical Document CTD A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use.
Community-Based Clinical Trial CBCT A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
Comparator (Product) An investigational or marketed product (i.e. active control), or placebo, used as a reference in a clinical trial.
Compassionate Use A method of providing experimental therapeutics prior to final regulatory agency approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained by the patient’s physician from the regulatory agency for “compassionate use” of an experimental drug or therapy.
Complementary and Alternative Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc.
Compliance Adherence to all the trial-related requirements, GCP requirements and the applicable regulatory requirements. in relation to trials
Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.
Confidentiality Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants’ consent to the use of records for data verification purposes must be obtained prior to the trial and assurance must be given that confidentiality will be maintained. The Informed Consent Document will explain how personal health information and study data will be used in accordance with pertinent data protection laws and regulations. in regard to trial participants
Consent Form A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.
Contract A written, dated, and signed agreement between two or more involved parties, that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Contraindication A specific circumstance in which the use of certain treatments are not allowed usually because they could be harmful or fatal.
Control Group A control is the standard by which experimental observations are evaluated. A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
Controlled Trial A control is a standard against which experimental observations may be evaluated. In a controlled clinical trial, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo
Cooperative Research Group A network of researchers at public and private institutions under which research protocols are designed and made available to evaluate treatment methodologies. Examples are Southwest Oncology Group (SWOG), Gynecologic Oncology Group (GOG), Children’s Cancer Group (CCG), etc.
Coordinating Community A committee that a sponsor may organize to coordinate the conduct of a multi-centre trial.
Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multi-centre trial.
Crossover Trial A clinical trial in which all participants receive both treatments, but at different times. At a predetermined point in the study, one group is switched from the experimental treatment to the control treatment (standard treatment), and the other group is switched from the control to the experimental treatment.
Curriculum Vitae CV Document prepared by an investigator to summarize his/her education, training, and expertise.
Data Management The process of handling the data gathered during a clinical trial. May also refer to the department responsible for managing data entry and database generation and/or maintenance.
Data Queries Questions or inquiries from the sponsor for clarification of the data on the case report forms (CRFs).
Data Safety Monitoring Board DSMB A committee, independent of the sponsor, composed of clinical research experts that reviews trial data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved and further continuing the study would not benefit the patients.
Data Safety Monitoring Plan This plan is meant to assure that each clinical trial has a system for appropriate oversight and monitoring of the conduct of the trial. This oversight ensures the safety of the participants and the validity and integrity of the data
Deception Intentionally misleading or withholding information about nature of experiment.
Declaration of Helsinki A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964. The Declaration addresses ethical issues for physicians conducting biomedical research involving humans. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.
Delinquencies Data that have not been sent in a timely manner or data queries from the sponsor that have not been answered.
Demographic Data The characteristics of participant group or populations. This could include data on race, age, sex and medical history, all of which can be relevant to the clinical trial study findings.
Designee A qualified individual, such as a pharmacist, research nurse, or study coordinator, delegated in writing by the PI to manage investigational drugs. “Qualified” means that the individual has been trained and has a comprehensive knowledge of the study protocol, the investigational drug (including the basic pharmacology of the drug)
Device An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, that is used to diagnose, cure, treat, or prevent disease. A device does not achieve its intended purpose through chemical action or metabolism in the body.
Diagnostic Trial Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.
Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any part (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects’ identities and sponsor’s proprietary information.
Documentation All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, adverse events, and the actions taken.
Dose response The effect of a specific dose of drug, chemical, or ionizing
radiation.
Dose tolerance Determination of the dose that can be tolerated in humans without
serious side effects.
Dose-Ranging Study A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.
Drug As defined by the Food, Drug and Cosmetic Act, drugs are “articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals.”
Drug Control Authority DCA A regulatory authority established for the purpose of regulating the Control of Drugs and Cosmetics Regulations, 1984
Drug or Device Accountability Records DAR Required documentation for material accountability, quantity used and left over, and date of disposal.
Drug Product A finished dosage form (e.g. tablet, capsule, or solution) that contains the active drug ingredient usually combined with inactive ingredients.
Drug-Drug Interaction A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.