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Clinical Research Dictionary Result

Clinical Research Dictionary Result

Absorption

The route and rate that a compound gets into the system (bloodstream)


 

Active Ingredient

The pharmacolgically active part of any medication. Many pharmaceutical products contain inactive ingredients that create the formulation.


 

ADME

Absorption, Distribution, Metabolism and Excretion. This describes the four stages that a pharmaceutical product would go through when administered to a human.


 

Advanced Technology Medicinal Product (ATMP)

Any one of the following: A gene therapy medicinal product; a somatic cell therapy medicinal product; a tissue engineered product


 

Adverse Drug Reaction (ADR)

In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function


 

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally ssociated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product


 

Aetiology

The factors involved in causing a disease.


 

Algorithm

A procedure to assist the structured achievement of an outcome that involves a series of alternative decisions


 

Analgesic

Drugs to relieve or reduce pain


 

Analysis of Variance ANOVA

A statistical technique to determine whether the mean values of different treatment groups are the same or different.


 

Anaphylactic Shock

Severe generalised form of anaphylaxis which may lead to a sudden attack of wheezing, collapse, cardiac arrest and may lead to death


 

Anaphylaxis

Severe allergic reaction


 

Annexe 13

Annex to Eudralex Vol 4 – covers GMP requirements for Investigational Medicinal Products


 

Applicable Regulatory Requirement(s)

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.


 

Area Under Curve (AUC)

Plot of concentration of a drug against time. Used as a method of comparing bioavailability of different products


 

Audit

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).


 

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 (paper or electronic) that allows reconstruction of the course of events.


 

Batch Release Certificate

A document signed by the Qualified Person to certify that a batch of medicinal product has been manufactured to the appropriate standard for its intended use. See also QP Release


 

Bayesian Approaches

Approaches to data analysis that provide a posterior probability distribution for some parameter (e.g. treatment effect), derived from the observed data and a prior probability distribution for the parameter. The posterior distribution is then used as the


 

Bias

General term suggesting favouritism for one possibility over another


 

Bioavailability

A measure of the amount of active drug which enters the appropriate body system and is therefore available at the target site.


 

Bioequivalence Study

Bioavailability study to compare two products to determine whether they have the same bioavailability profile


 

Biometrics

This term can mean different things. It is generally used to refer to the process of the statistical analysis of clinical trial data. The definition can also mean the department of ‘Statistics’ within a pharmaceutical/CRO company and this can sometimes be broadened to include the department of ‘Data Management’.


 

Biostatistics

The branch of mathematics applied to the analysis of clinical trial data to test hypotheses


 

Biotechnology

A set of biological techniques developed through basic research and now applied to research and product development.In particular, the use by industry of recombinant DNA, cell fusion, and new bioprocessing techniques. Biotechnology products include antibiotics, insulin, interferon, recombinant DNA, and techniques such as waste recycling.


 

bis die (bd)

Twice a day


 

bis in die (bid)

Twice a day


 

Black List

List of investigators that the FDA considers not appropriate to conduct clinical trials. FDA will not accept studies conducted by these investigators


 

Blind Review

The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalising the planned analysis


 

Blinding

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the 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 assignment(s). Sometimes blinding is referred to as masking


 

Blister Packaging

Packaging used to separate individual doses of medication


 

Block Size

In a multicentre study subjects are randomly allocated to their study medication. Treatments are randomly organised in blocks so that an equal number of patients in each block will receive each of the treatments. The size of the block depends on the number of patients that each site is expected to recruit along with the number of treatment groups. For example, a 2 treatment group study with a block size of 4 could have blocks: AABB, ABAB, BABA, BBAA etc. Putting these together would give a randomisation schedule AABBABABBABA….. And therefore after every multiple of 4 subjects there will be an equal of subjects allocated to treatment A and treatment B. Randomisation schemes are made of randomly allocated blocks.


 

Brand Name

The trade name of a pharmaceutical product.


 

British National Formulary (BNF)

Guide to prescribing in the National Health Service with pharmacologically arranged notes for prescribers


 

British Pharmacopoeia (BP)

This document provides an authoritative standard for the quality of substances, preparations and articles used in medicine and pharmacy. Volume I deals with the medicinal and pharmaceutical preparations and gives the infra-red reference spectra needed for the identification of many of these materials. Volume II contains information of formulated preparations, blood and immunological products, radiopharmaceuticals and surgical materials. The appendices contain the procedures for testing compliance with the standards.


 

Carryover Effect

Any effect of a drug which lasts beyond the period of treatment


 

Case Report 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.


 

Categorical Data

Data which are evaluated by sorting the values into various categories (eg low, medium, high) or data that is only available in categories (eg ethnic origin, gender)


 

Causality

The relationship of an adverse event to the use of study medication. The likelihood of the event being caused by the study drug is often classified as: unknown, not related, possible, probably, definite


 

CDER

Center for Drug Evaluation and Research. This is a division of the FDA that deals with the approval of new drugs.


 

Central Laboratory

A single laboratory (often a contract laboratory) which is contracted to perform laboratory testing for some or all sites in a multicentre clinical trial


 

Central Office for Research Ethics Committees (COREC)

The body with day to day responsibility for the operation and governance of Research Ethics Committees in the UK


 

Centralised Monitoring

Montoring activities carried out without visiting the investigational site, usually at the sponsor or CRO offices. These activities would include data review, telephone and e-mail contact with site staff, analysis of data trends etc.


 

Certificate of Analysis

Document certifying the quality of a medicinal product


 

Certified Copy

A copy (irrespective of the type of media used) of the original record that has been verified (e.g. by a dated signature or by generation through a validated process) to to have the same information, including data that describe the context, content, and structure, as the original.


 

CFR: 21CFR part 11

US regulation governing electronic records and electronic signatures


 

CFR: 21CFR part 312

US regulation governing the conduct of clinical trials in medicinal products.


 

CFR: 21CFR part 50

US regulation governing informed consent for research subjects.


 

Challenge agent

A product given to a subject in order to elicit a response, such as an immunological reaction.


 

Chief Investigator (CI)

The main investigator for a clinical trial in the UK, and the person who applies via COREC for Main REC approval for the clinical trial


 

Clean Database

A database of data which is considered to be free from all errors


 

Clinical Research Associate (CRA)

Person who is responsible for recruiting investigators, initiating studies, monitoring and closing down sites at the end of studies


 

Clinical Significance

Any change in the patient’s clinical condition (which may or may not be due to treatment) which is regarded as being important. Sometimes changes observed in clinical studies may prove to he statistically significant but they may not be clinically significant (eg. changes in particular blood tests).


 

Clinical Trial Administrator (CTA)

A person, normally employed by a pharmaceutical company or CRO to perform administrative tasks associated with running clinical trials. The exact responsiblities of this role vary between organisations


 

Clinical Trial Agreement (CTA)

The agreement between the Sponsor and the Investigator on the conduct and financial aspects of the investigators participation in the study.


 

Clinical Trial Authorisation (CTA)

Authorisation granted by the Competent Authority of a Member State to conduct a clinical trial in that Member State


 

Clinical Trial Coordinator

Person at a study site responsible for co-ordinating the study and ensuring that the CRFs are completed properly


 

Clinical Trial Materials

The supplies provided by a sponsor to an investigator in order that they can undertake a clinical trial. Examples include protocol, CRFs, laboratory kits etc.


 

Clinical Trial/Study

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 any 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 terms clinical trial and clinical study are synonymous.


 

Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report


 

Close Down/Close Out

The act of terminating a study. Sites may be closed down because the study has been completed.


 

Code Break

Revealing which medication a subject has been assigned during a blinded clinical trial. This is usually done in an emergency when the treatment of the emergency is dependent on knowing which treatment the subject has been taking.


 

Code of Federal Regulations (CFR)

American legislation: “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.” Definition taken from the US government information portal.


 

Cohort

A cohort is group of people who share a common characteristic in a defined time frame. Subjects in a randomised controlled trial are in essence a ‘cohort’ of people who all fulfil the prespecified criteria for entry to a trial. Groups of subjects followed over time, eg a group of children born in a specific year and followed from birth would also be a cohort.


 

Cohort Study

A cohort study is one in which a group of subjects (a cohort) are followed over a period of time for a specific reason, e.g. to assess their experiences in a period of time. A randomised controlled trial is a high level form of cohort study, at the other extreme is to follow a group of children from birth to 10 years old and see what medical conditions they encounter.


 

Committee on Proprietary Medicines for Human Use (CHMP)

Subcommittee of EMEA governing medicinal products for human use


 

Comparator

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.


 

Competent Authority (CA)

Competent Authority – a body which has the authority to act on behalf of the government of an EU Member State to ensure that the requirements of the Directives are carried out in that Member State. In respect of clinical trials this means the authority which grants the Clinical Trials Authorisation and Manufacturing Authorisation and conducts GCP, GMP and GLP inspections


 

Compliance

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.


 

Compliance (treatment)

A measure of whether patients have taken their study medication correctly in terms of dosing and timing.


 

Concomitant Medication

Medication taken by a patient in addition to the study medication. This may be a prescription drug or an over the-counter preparation that is bought by the patient and taken during the trial period.


 

Concomitant Treatment

Treatment which is undertaken by the patient at the same time as the study medication (examples include physiotherapy, diet, surgery).


 

Confidence Intervals

These define a range of values within which the true population parameter (e.g. the population mean) is likely to lie. Usually 95% confidence limits are quoted


 

Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.


 

Confounding

A confounding factor or variable is one that may have a causal relationship with the outcome but has either not been measured or not been controlled. Example, a treatment effect is noted between two groups in a trial. If there are differences in the demog


 

Consent Form

Document which is signed by the patient to indicate their agreement to participate in a clinical trial


 

Content Validity

The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure.


 

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.


 

Contract Research Organisation (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.


 

Control Group

In a study where a comparison is made between a group receiving treatment and a group that does not receive treatment, the latter group is the control group


 

Coordinating Committee

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.


 

Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.


 

Council for International Organizations of Medical Sciences (CIOMS)

The Council for International Organizations of Medical Sciences is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. Their main objective is to facilitate and promote international activities in the field of biomedical sciences


 

Cox Proportional Hazards

A statistical analysis technique to compare time to event (sometimes called survival data) between two or more treatment groups.


 

CRA Visit Log

Document kept in the investigators site file which signed by the CRA after each visit to provide evidence of the visit


 

Curriculum Vitae (CV)

Document outlining a person’s educational and professional history


 

Data

Observation of measurement that is recorded in a CRF


 

Data and Safety Monitoring Board (DSMB)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.


 

Data Handling

Process and procedure by which data is dealt with from its initial recording in a CRF to becoming clean data


 

Data Management

the development and execution of architectures, policies, practices and procedures in order to manage the information lifecycle needs of an enterprise in an effective manner.


 

Data Monitoring Committee (DMC)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.


 

Data Query

Query raised to ask for correction or clarification of a data point


 

Database

Software to store and manipulate data


 

Declaration of Helsinki

Guideline document drawn up by the World Medical Assembly which outlines the fundamental principles to be followed when conducting research using human subjects. The first version was issued in 1964.


 

Development Safety Update Report (DSUR)

Annual report containing all safety information for a product which is in development. More information can be found in ICH guideline E2F


 

Direct Access

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (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.


 

Discontinuation of a Trial

Stopping a clinical trial. This may occur for various reasons, such as lack of efficacy, slow subject recruitment, data from other studies which indicate that it is unethical or not cost effective to continue development of the product.


 

Discontinuation of a Trial Subject

A subject’s participation in a clinical trial may be stopped by the subject or the investigator at any time. Among other things this may because of side effects, intercurrent illness or withdrawal of consent.


 

Disease

Any alteration of the structure or function of organs or tissues may be called a disease


 

Distribution

Distribution describes how a compound is transferred around the body


 

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, and the actions taken.


 

Dose Response Curve

When the dose (x-axis) and the corresponding observed response is plotted on a graph the curve obtained is known as a dose response curve. The higher the administered dose the better the response.


 

Dosing Schedule

The amount, frequency and duration of the trial medication.


 

Double Blind Trial

A trial in which the patient and the investigator are both unaware of which treatment the patient is receiving.


 

Double Data Entry

Data are entered into the database independently by two different people. Electronic checks highlight any discrepancies which can then be resolved. Double data entry reduces the errors associated with data entry to extremely low levels.


 

Double Dummy Technique

A technique which enables a Trial comparing two drugs with different dose forms (eg. tablets and capsules) to be conducted double blind. For a trial comparing a tablet with a capsule each patient will have to take one tablet and one capsule at each dosing. One group of patients will take an active tablet and a placebo capsule. The other group will take an active capsule and a placebo tablet. By using this technique neither the patient nor the investigator is aware of which active medication the patient is receiving. This is a very common technique in comparative clinical trials.


 

Drop Out

A subject who leaves the trial for any reason.


 

Drug

Any substance in a pharmaceutical preparation which is used to modify or to explore physiological systems or pathological states.


 

Drug Accountability

A record of what happens to investigational medicinal product provided for a clinical trial. This may include receipt, storage, dispensing, return and destruction, and should be maintained at the smallest unit level, ie every tablet, vial, patch, etc should be accounted for.


 

Drug Development

The process in which a drug is discovered in a laboratory and subjected to a series of animal and clinical tests culminating in the granting of a Marketing Authorisation.


 

Drug Level

The level of a drug that is found in the blood, urine, faeces or which has been deposited in various bodily tissues.


 

Drug of Choice

The preferred drug treatment for a particular condition. It may also be known as the standard treatment.


 

Dual energy X-ray absorptiometry (DXA)

DXA was previously referred to as DEXA. DXA is a method of measuring bone mineral density in humans through the use of x-ray technology. It is the most widely used and most thoroughly studied bone density measurement technology.


 

Due Diligence

The process of examining the information regarding another company with a view to merging with, taking over or purchasing specific assets from that company.


 

Duration of Treatment

The length of time each patient in the trial receives treatment.


 

Duration of Trial

The period from the start of a clinical trial to its completion by the investigator(s).


 

EDC – Electronic Data Capture

A means of capturing data for a clinical trial in an electronic format. This could include electronic Case Report Forms, Patient Diary Cards or other patient reported outcomes and Source Data


 

Efficacy

The ability of a drug to produce the purported beneficial effects of treatment on the course or the duration of a disease.


 

Eligible Subjects

Subjects who meet the inclusion and exclusion criteria laid down in the protocol. An eligible patient is not necessarily the same as an entered patient as they may not consent to take part in the trial.


 

Elimination

Elimination describes how a compound leaves the body


 

Endoscopy

A technique in which the interior of the stomach and the duodenum can be examined visually using a fibre optic endoscope (or gastroscope) which is inserted into the patient via the mouth.


 

Endpoints

A measurement of a specific parameter made on a patient within a clinical trial. These measurements provide data to answer the objectives of a trial. For example, in a trial to compare two treatments for reducing blood pressure, an endpoint could be the change in blood pressure from pre-treatment to 6 months after treatment commenced for each patient.


 

Enteric Coating

A coating which protects a medicine from the acidic content sof the stomach and allows it to pass into the intestine where the coating breaks down and the drug can be absorbed.


 

Equivalence Trial

A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and


 

Escape Medication

Medication which may be taken a patient in the event of a treatment failure of the Investigational Medicinal Product during a trial.


 

Essential Documents

Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced


 

ESUR

European Society of Urogenital Radiology


 

Ethical Drugs

Medicinal products which are only available as prescription medicines


 

Ethics Approval

The process of reviewing a trial protocol plus the associated Patient Information Sheet and the Patient Consent Form by a duly constituted ethics committee. The purpose of the review is to ensure that the rights, safety and well being of trial subject are protected.


 

Ethics Committee

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline.


 

EU Directive

A legal document produced by the European Parliament which has legal force across Europe, but which requires implementation in each Member State by means of local legislation


 

EU Guideline

A document produced by the European Parliament which has no official legal force, but which contains guidelines which inspectors expect to be followed


 

EU Regulation

A legal document produced by the European Parliament which has legal force and direct applicability across Europe


 

EudraCT

A European database containing details of all clinical trials in Europe. Every clinical trial which is subject to the Clinical Trials Directive must be entered onto this database


 

EudraCT Number

A number allocated by the EudraCT database which must be quoted on all correspondence with Competent Authorities and Ethics Committees


 

Eudralex vol 4

EU Guidelines detailing GMP Requirements


 

European Medicines Agency (EMA)

Formerly known as the EMEA, the Regulatory body governing medicinal products throughout Europe


 

European Medicines Evaluation Agency (EMEA)

Former name of the EMA, the Regulatory body governing medicinal products throughout Europe


 

Evidence Based Medicine (EBM)

The Centre for Evidence Based Medicine define this as “Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients”. EBM uses a combination of the expertise of an individual with the evidence provided through research which will include clinical trials, meta analyses as well as other sources of evidence like genetics and immunology. The prescriber needs to keep up-to-date with the latest evidence so that they can make an informed decision about treatment options. Failure to do so may result in effective treatments not being prescribed. Criticism of EBM revolves around the evaluation of medicine based on cost vs effectiveness to create a prescribing list based on financial rather than clinical interpretation.


 

Exclusion Criteria

A list of criteria, any one of which would exclude a patient from participating in a clinical trial.


 

Expert Report

A report required by the Regulatory Authorities regarding some aspect of a Pharmaceutical Preparation (eg. Toxicology, Chemistry and Pharmacy, Clinical). The author of such a report must be an expert in that particular field, but may be employed by the sponsor.


 

Expiry Date

The latest date which a product or a batch of material may be used.


 

FDA 1572

A Statement of Investigator Form which gives the investigators educational background and clinical expertise and appointments. It must be completed and submitted to the FDA for all investigators taking part in clinical trials under FDA regulations.


 

Feasibility

Assessment of whether a clinical trial is feasible to run, this would normally be done by collecting information from potential investigators about the numbers of subjects they would be able to enter and in some cases the potential investigators views on the proposed protocol design.


 

File note

A document usually added to the trial master file (TMF) to provide clarification of a situation or scenario. For example, to explain why an SOP has not been adhered to, or why a document is missing or a copy has been provided instead of a required original. A file note should be signed and dated.


 

Final Report

A complete and comprehensive description of the trial after its completion including a description of experimental materials, a presentation and evaluation of the results, statistical analyses and a critical statistical and analytical appraisal.


 

Financial Agreement

Agreement between the sponsor and the investigator or other parties conducting the clinical trial which outlines the payment for work done in conducting the trial.


 

Financial Disclosure

Disclosure by investigational site staff of any financial interest in the sponsor organisation or the outcome of the trial. Required by FDA for IND studies


 

First Patient in

A clinical trials term of art referring to the date and time the first subject meeting the trial’s inclusion or exclusion criteria is enrolled and randomised into a study


 

First-in-Man Trial

The first phase I trial in which a new drug is given to man.


 

Flow Chart

A diagram illustrating the overall design of a trial including the number of visits required and the evaluations to be undertaken at each visit.


 

Follow Up

A further consultation with an investigator to evaluate the efficacy and the safety of the trial medication or to obtain further information e.g. on SAEs.


 

Food & Drug Administration (FDA)

The American government body which governs food and drug products in the US. They also oversee clinical research and conduct GCP, GMP and GLP inspections.


 

Fraud

The deliberate falsification of forgery of clinical trial data with the intention to mislead.


 

Frequentist Methods

Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realisations of the same experimental situation.


 

Full Analysis Set

The set of subjects that is as close as possible to the ideal implied by the intention-to treat principle. It is derived from the set of all randomised subjects by minimal and justified elimination of subjects.


 

GCP Guidelines

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.


 

Generic Name

The non-brand name by which a chemical compound is commonly known.


 

Genomics

Is the study of the genes of an organism. Identifying the characteristics of genes can lead to new diagnoses and therapy for diseases.


 

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 Laboratory Practice (GLP)

Good Laboratory Practice refers to a system of management controls for laboratories and research organisations to ensure the consistency and reliability of results. GLP applies to non-clinical studies conducted for the assessment of the safety of chemical


 

Good Manufacturing Practice (GMP)

“the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use” GMP Directive (2003/94/EC)


 

Half Life

The time taken to eliminate halt the drug present in the body. It may be expressed as the time taken for the plasma concentration to fall by 50% when absorption and distribution has been completed.


 

Hawthorne Effect

The effect the experimenter may have on the outcome of a trial.


 

Hazard Ratio

A measure comparing two treatment groups with respect to the risk of having an event over a specific time period.


 

Heart Rate

The frequency of the heart beat.


 

Histogram

A chart which displays grouped data and in which the width of each bar is proportional to the class interval and the area of the bar is proportional to the frequency of that class.


 

Historical Control

In some circumstances it is not possible to randomise patients to different treatment groups. In this case a group of patients whose outcome is already known (historical) is selected and compared to the outcome of the current patients.


 

Holter Monitoring

24 hour ECG monitoring using portable recorders


 

Hypothesis

A statement that is to be tested to attempt to proved through means of an experiment


 

ICH GCP

The guideline, E6, produced by the International Conference on Harmonisation which covers Good Clinical Practice. See also GCP


 

Inclusion Criteria

The criteria which subjects must meet to be eligible to participate in a clinical trial.


 

Indemnity

The insurance cover provided by the company to the Investigator, (and if necessary, the hospital and the local area health authority for hospital physicians) in event of an untoward occurrence which may result in the patient suing the doctor and the local area health authority. It is only valid if the medication has been used in accordance with the protocol and it does not cover the doctor for acts of negligence. The investigator’s own medical insurance would cover such an event.


 

Independent Data Monitoring Committee (IDMC)

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.


 

Ineligible Patients

Patients who not meet the inclusion and exclusion criteria laid down in the trial protocol.


 

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. Informed consent is documented by means of a written, signed and dated informed consent form.


 

Initiation Visit

The visit at which the CRA trains with the investigator and site staff in the trial protocol, procedures, CRFs and if necessary GCP. Following this visit, the investigator should be able to recruit patients into the trial.


 

Inspection

The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).


 

Institutional Review Board (IRB)

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.


 

Intention to Treat (ITT)

The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. It has the consequence that subjects allocated to a treatment group should be followed up, assessed and analysed as members of that group irrespective of their compliance to the planned course of treatment.


 

Interaction

The situation in which a treatment contrast (e.g. difference between investigational product and control) is dependent on another factor (e.g. centre). A quantitative interaction refers to the case where the magnitude of the contrast differs at the differ


 

Interim Analysis

An analysis performed before all patients have completed the trial. The timing of such analyses should be pre-determined when the trial is being planned. They should not take place too frequently. One reason for undertaking an interim analysis is to terminate the trial early if the result is favourable or unfavourable. Termination should be done with due care and consideration for the trial patients.


 

Interim Clinical Trial/Study Report

A report of intermediate results and their evaluation based on analyses performed during the course of a trial.


 

International Conference on Harmonisation (ICH)

International Advisory group made up of representatives from The EU, The USA and Japan who produce guidelines for harmonised regulatory requirements for medicines across those three regions


 

International Conference on Harmonisation (ICH)

International Advisory group made up of representatives from The EU, The USA and Japan who produce guidelines for harmonised regulatory requirements for medicines across those three regions


 

Invasive Procedure

Any procedure which involves the insertion of a piece of equipment or apparatus into a subject


 

Investigational Medicinal Product (IMP)

Clinical Trials Directive article 2(d):“a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial…” GCP Directive article 10: “’types of medicinal products’ nclude blood products, immunological products, cell therapy products, gene therapy products, biotechnology products, human or animal extracted products, herbal products, homeopathic products, radiopharmaceutical products and products containing chemical active ingredients”


 

Investigational Medicinal Product Dossier (IMPD)

A document submitted as part of the Clinical Trial Authorisation application. The IMPD should give information on quality of any IMP to be used in the clinical trial, including reference products and placebos. It should also provide data from non-clinical studies and the previous clinical use of the IMP or justify in the application why information is not provided. Source: EU document: Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial


 

Investigational New Drug (IND)

Regulatory approval to conduct clinical trials using Investigational Medicinal Product where the trial is conducted in the US or the IMP is sourced from the US. An IND is granted by the FDA


 

Investigational Site

The location(s) where trial-related activities are actually conducted


 

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.


 

Investigator Meeting

A meeting which is attended by all the investigators who have agreed to participate in a multicentre trial. The purpose of the meeting is to inform the investigators about the investigational medicinal product and the clinical trial. There may also be some training in GCP and regulatory requirements It is most often conducted before the start of the trial, but there may be more than one investigator meeting.


 

Investigator Selection

The process of choosing the investigational sites to participate in a clinical trial. This is most often done by means of a site selection visit at which the investigator, staff and facilities are assessed by the CRA and the investigator is given information about the trial in order to decide whether they wish to participate.


 

Investigator Site File

The file, kept at the investigator site, which contains essential documents as outlined in ICH GCP chapter 8


 

Investigator’s Brochure (IB)

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects


 

Kaplan-Meier

A method of calculating the proportion of patients who are event free at a specific point in a trial. The estimates are usually presented as a graph with stepped descending lines showing the proportion event free as time progresses.


 

Labeling

The requirements for labeling of clinical trial material are laid down in various regulatory documentation including FDA Code of Federal Regulations and Annexe 13 to Eudralex Vol 4


 

Laboratory Data

The results of laboratory tests that are conducted as part of a clinical trial.


 

Laboratory Normal Ranges

A documented range of laboratory values which are considered to be normal for that patient population. Normal ranges are specific to the laboratory which publishes them.


 

Laboratory Normal Ranges

A documented range of laboratory values which are considered to be normal for that patient population. Normal ranges are specific to the laboratory which publishes them.


 

Lasagna’s Law

A well recognised phenomenon which states that as soon as a clinical trial begins all the subjects who were thought to be suitable for the study disappear.


 

Legally Acceptable Representative

An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial.


 

Liability

The state of being legally obliged or liable.


 

Loading Dose

The first dose which is larger than the usual dose to ensure that drug levels in the blood reach therapeutic levels quickly. The standard dose will then be sufficient to maintain the blood level of the drug within the therapeutic level.


 

Logistic Regression

A statistical analysis technique to compare two or more treatment groups for an endpoint that is of a Yes/No or response/no response format. The test is based around testing whether the odds ratio is significantly different from 1.


 

Lost to follow up

A subject who does not return for trial visits and cannot be contacted is described as lost to follow up.


 

Manufacturing Authorisation

Competent Authority permission to manufacture a medicinal product


 

Manufacturing Authorisation for Investigational Medicinal Product (MAIMP)

Competent Authority permission to manufacture an investigational medicinal product


 

Marketing Authorisation (MA)

System which provides approval to market a medicine within the European Union


 

Masking

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the 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 assignment(s). Sometimes blinding is referred to as masking.


 

Mean

Term usually used to refer to the average. Obtained by summing the observations and dividing this figure by the number of observations.


 

MedDRA

Medical Dictionary for Regulatory Activities – the internationally accepted medical terminology for use in drug regulation.


 

Median

This is the middle observation for a dataset ordered from lowest to highest. If there is an even number of observations the median is obtained by adding the two middle observations and dividing by 2. For an odd number of observations the median is the middle observation of an ordered dataset.


 

Medical Adviser

The person responsible for providing medical input into clinical trial programmes and providing medical expertise for one or more therapeutic areas in which clinical trials are being conducted. The medical adviser plays a major role in the evaluation of any adverse events occurring in clinical studies.


 

Medical History

Information on all previous and current medical conditions and treatments for a patient


 

Medicinal Product

Any product which may be given to a patient to produce a therapeutic improvement in the patient’s condition.


 

Medicines and Healthcare Regulatory Authority (MHRA)

Competent Authority for the UK, ie the government body which grants (among other things) licences for clinical trials and and manufacturing and marketing of medicinal products. The MHRA also conducts clinical trial inspections.


 

Member State

Any country which is part of the European Economic Area.


 

Metabolic Pathway

A series of chemical transformations that take place within cells in order to convert one compound into another.


 

Metabolism

Metabolism describes the biochemical modification or degradation of the compound in the body.


 

Metabolite

A chemical compound produced as a result of chemical changes to a drug which occur in the body. A metabolite may or may not produce therapeutic effect and adverse reactions.


 

Minimisation

A method of randomisation where the treatment allocation for each subject is centrally controlled in an attempt to balance the split of treatment allocation across numerous strata. This is an example of dynamic allocation that minimises the imbalance of patients in treatment groups and strata while still maintaining an element of chance in the allocation


 

Minimum Effective Concentration (MEC)

The lowest concentration of drug in the systemic circulation at which it can produce a therapeutic effect.


 

Minimum Toxic Concentration (MTC)

The lowest level of drug in the systemic circulation which produces toxic effects in patients.


 

Ministry of Health, Labour and Welfare (MHLW/MHW)

Regulatory Authority which governs medicines in Japan.


 

Missing Data

If entries in the CRF are left blank then they are known as missing data.


 

Mode

The most frequently occuring value or values in a dataset


 

Monitor

A person appointed by the sponsor or Contract Research Organisation (CRO) who is responsible for verifying the protection of subjects, the quality of the data and protocol and regulatory compliance. The monitor appropriately trained and experienced and thoroughly familiar with the clinical trial.


 

Monitor’s Visit Log

This is a sheet which is kept in the Investigator’s Trial File, It is signed and dated by all clinical research personnel visiting that site and provides a record of the visits made to the trial site by all clinical research staff from the pharmaceutical company (or CRO).


 

Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).


 

Monitoring Plan

A document that describes the strategy, methods, responsibilities and requirements for monitoring the trial.


 

Monitoring Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.


 

Monitoring Visit Report

A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.


 

Multicentre 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.


 

Mutagenicity Testing

All new drugs are subjected to a bacterial mutagenicity test (Ames Test) before being tested in man. An unequivocal positive result would prevent a new drug from being tested in man until further investigations have been conducted.


 

NABL

National Accreditation Board for Testing and Calibration Laboratories. The NABL undertakes the assessment and accreditation of Testing and Calibration Laboratories, in accordance with the international standard ISO / IEC 17025 and ISO 15189.


 

Named Patient Basis

An unlicensed (drug may be supplied to a physician for use in a particular patient on a named patient basis. Information about the patient’s experience with the drug should be reported to the sponsor.


 

National Research Ethics Service (NRES)

Has replaced COREC (Central Office for Research Ethics Committees) and is the managing body for Research Ethics Committees in the UK


 

New Chemical Entity

A new chemical compound which is being developed as a prescription medicine for the treatment or prophylaxis of a medical condition.


 

New Drug Application (NDA)

An application to the FDA for a licence to market a new drug in the United States of America.


 

Nominal Data

Another name for categorical data.


 

Non Investigational Medicinal Product (NIMP)

Medicinal product used in a clinical trial which does not come under the definition of Investigational Medicinal Product. Examples in EU guidance are rescue medication, allowed concomitant medication, background medication, challenge agents or medicinal


 

Non-Comparative Trial

A trial in which no comparative group is used


 

Non-Evaluable Patient

A patient whose trial data can not be included in the efficacy analysis


 

Non-Interventional trial

A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation.


 

Non-Invasive Procedure

A procedure which does not involve insertion of equipment or apparatus into a patient take readings or to undertake assessments.


 

Non-Therapeutic Trial

A clinical trial in which subjects are not expected to receive any medical benefit from the Investigational Medicinal Product. An example would be Phase I healthy volunteer studies.


 

Nonclinical Studies

Biomedical studies not performed on human subjects.


 

Nuremberg Code

Code of practice for research in human subjects drawn up following the Nuremberg trials of war criminals in 1947.


 

Objective Measurement

Any measurement which is not dependent on individual judgement (eg. height, weight. laboratory result etc).


 

Observational Study

A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).


 

Odds Ratio

Defined as the ratio of the odds of one treatment group compared to another. The odds are defined as the number of times more likely you are to have an event compared to not having it. If in one groupof 100 people 90 people have the event and 10 people do


 

Off-label

The use of a drug in patients which falls outside the terms of the Marketing Authorisation, for example for an unapproved indication or in a subject population not included in the MA.


 

On-site Monitoring

Monitoring activities carried out at the investigational site


 

Open Trial/Open Label

A clinical trial in which no blinding occurs and all participants are aware of which medication the subjects are taking.


 

Opinion Leader

A leading authority on a particular subject who is recognized as an international, national or local expert


 

Optimum Dose

The dose which produces the maximum effect in the majority of patients.


 

Ordinal Data

Any data that can be ordered or ranked.


 

Orphan Drug

A drug which is developed for the treatment of a rare condition or is effective in a therapeutic area with only a small number of patients Special dispensations exist for these drugs to encourage their development given the small potential for these drugs to be profitable.


 

Outlier

A data value which lies a long way from the main body of data. High outliers lie above the main body of the data whereas low outliers lie below it.


 

Over-the-counter (OTC)

Drugs which can he purchased in a Pharmacy without a prescription.


 

P-value

The output from a statistical test indicating whether a difference between two groups has been demonstrated or not. A p-value of less than 0.05 generally is interpreted as a good result and allows the claim of ‘a statistically significant difference’


 

Package Insert

A leaflet which is included with a proprietary medicine. It gives prescribing information for the drug and also the contraindications and precautions which must be undertaken when using the drug.


 

Paediatric Investigation Plan (PIP)

Plan outlining research to be done in the paediatric population for a new medicinal product. Now required by EU law unless a waiver or deferral is granted.


 

Paediatric Use Marketing Authorisation (PUMA)

Specific marketing authorisation for use of a marketed product in a paediatric population.


 

Parallel Group Trial

A trial in which two or more treatments are compared in parallel by patients being divided into groups. One group will be allocated to recieve one of the treatments for the duration of the trial and the other group to recieve the other treatment etc. At the end of the trial the groups are compared to determine differences between treatments.


 

Partial Responder

A patient who responds partially to treatment with a particular drug but who does not show a complete response. Many cancer patients may he classed a partial responders when they show partial remission of their disease.


 

Pathogenesis

The origin and the course of a disease


 

Patient Information Leaflet (PIL)

Patient Information Leaflet – leaflet supplied by the manufacturer of a licensed medicine, authorised by the MHRA in the UK, which is intended for the patient


 

Patient Pack/Treatment Pack

The packs of medication that are provided to a patient during a clinical trial.


 

Patient Recruitment

The act of entering a patient into a clinical trial by an investigator.


 

Per Protocol Set (Valid Cases, Efficacy Sample, Evaluable Subjects Sample)

The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerati


 

Pharmacist

A person qualified to prepare and dispense drugs.


 

Pharmacodynamics

The branch of pharmacology concerned with the action of drugs on the physiology of the body.


 

Pharmacokinetics

The branch of pharmacology concerned with the absorption, distribution, metabolism and elimination of a drug and its metabolites.


 

Pharmacologist

A pharmacologist is someone who studies how substances (including pharmaceuticals) interact with living organisms to produce changes in function. Clinical Pharmacologists are involved with the effects that medications have on human functions.


 

Pharmacology

The study of drugs including their characteristics, actions and uses.


 

Pharmacopoeia

A standard book giving information on the identity, purity and the identification of drugs. In most countries there is an official pharmacopoeia and drugs must comply with the standards laid down


 

Pharmacovigilance

A technical term used for identifying and responding to risk/benefit issues emerging for authorised medicines as used in clinical practice, and including the effective dissemnation of uch information to optimise the safe and effective use of medicines Source: MHRA Glossary


 

Pharmacy

The practice or the art of preparing and dispensing drugs. Also the place where drugs are compounded and dispensed.


 

Pharmacy Site File

The part of the invesitgator site file which is held in the pharmacy. This will include all relevant documentation regarding receipt, storage, dispensing, accountability and destruction of Investigational Medicinal Products


 

Phase 1 Trial

Search again using the term Phase


 

Phase 2 Trial

Search again using the term Phase


 

Phase 3 Trial

Search again using the term Phase


 

Phase I Trial

The first studies in man with a new drug. They are usually conducted in normal, healthy male volunteers. The primary aims are to determine the safety and tolerance of the new drug in man and to find the dose to be used in future clinical trials.


 

Phase I Unit

A unit which has been designed specifically for the conduct of studies involving normal healthy volunteers These units normally have access to crash facilities and medical personnel, and may be attached to a hospital or part of a pharmaceutical company or CRO facilities.


 

Phase II Trial

The first clinical studies with a new drug in patients with the condition being investigated. They are usually conducted in a small number of hospitalised patients so they can be monitored closely. The purpose of these studies are to confirm that the drug has a therapeutic effect, to assess the safety of the drug in patients and and to determine the optimal dose for further clinical trials.


 

Phase III Trial

The large multicentre comparative studies which are needed to show the safety and efficacy of the new drug compared to a standard drug or placebo. These studies are required for submission to the Regulatory Authorities in support of a Marketing Authorisation for the new drug, and are commonly referred to as “pivotal studies”.


 

Phase IIIa Trial

Those Phase III trials that are required by the Regulatory Authorities to determine the safety and the efficacy of the new drug.


 

Phase IIIb Trial

Phase III studies which are conducted following the Marketing Authorisation Application submission to provide further information about the drug, including data that can be used by the marketing department to promote the drug after the granting of a MA


 

Phase IV Trial

These are the clinical trials that are conducted with a drug after it has received a Marketing Authorisation.


 

Pivotal Trial

A trial which provides critical and statistically significant information to the Regulatory Authorities about the safety and efficacy of the new drug. These trials are essential to the granting of the Marketing Authorisation.


 

Placebo

This is an inactive substance (e.g. tablet, injection), which is administered as if it were aan active therapy, but which has no therapeutic value. Placebo controlled clinical trials are used to determine whether an investigational product has any benefit over a patient receiving no active therapy (ie the placebo). There is an effect known as placebo effect.


 

Placebo Effect

This is the phenomenon that a subject’s symptoms can be alleviated by an otherwise ineffective treatment, since the individual expects or believes that it will work.


 

Poisson Regression

A statistical analysis technique used to analyse endpoint data that is a count, eg number of exacerbations of asthma over a time period. The analysis technique compares two or more treatment groups and looks at whether one or more groups have a higher or lower rate of the event than the other group.


 

Post Marketing Surveillance (PMS)

These are observational studies of drug effects in a large number of patients following the granting of a Marketing Authorisation. The purpose of PMS studies are to evaluate the drugs as they are used to treat a wide spectrum of patients with particular focus on safety, although. additional data on efficacy may be obtained.


 

Power

This is the probability of getting the desired result of the trial given that the expected result is true. For example if prior to the trial you expect that the new treatment gives a response rate of 50% and the comparator gives a rate of 30%, a power level of 80% would suggest that if the estimates of response rates are true your trial would have an 80% chance of formally proving this difference.


 

Preclinical

Pertaining to the work that is undertaken before studies are conducted in man (ie, prior to Phase 1). This includes the animal testing that is necessary before the first dose can be given to a human volunteer.


 

Prescription Only Medicine POM

Medicine which is only available via a prescription from an appropriately qualified person such as a physician.


 

Prevalence

The incidence of a particular event in the population being studied.


 

Principal Investigator (PI)

Usually the main investigator at a trial site who has the overall responsibility for the conduct of the clinical trial at that site


 

pro re nata (prn)

Loosely translated from latin it is means “As the situation arises”. This is a dosing description that means that treatment should be taken as needed.


 

Product Specification File

“A reference file containing or referring to files containing all the information necessary to draft the detailed written instructions on processing, packaging, quality control testing, batch release and shipping of an investigational medicinal product” Annexe 13 to Eudralex Vol 4 – GMP requirements


 

Prognosis

A prediction of the duration and outcome of a particular disease and its response to medical treatment.


 

Project Manager

The leader of a project team who is charged with the responsibility of ensuring that the project is completed according to schedule and within budget.


 

Project Team

A group of individuals from different disciplines within the company who are charged with the responsibility for setting up and completing a specific project such as a clinical trial or product development programme.


 

Prophylactic

Any medication or device that prevents or helps to prevent the development of disease.


 

Prophylaxis

Measures taken to prevent the development or the spread of disease.


 

Proposal

Document detailing how an organisation would perform a specific service/project and how much they would charge.


 

Prospective Trial

A trial in which patients are recruited and followed according to criteria laid down in a protocol.


 

Proteomics

Is the large scale study of proteins. In the medical field proteomics is widely used to identify biomarkers that can be used as as a method to identify disease states.


 

Protocol

A document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.


 

Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol.


 

Protocol Deviation

The act of a patient deviating from the requirements of a protocol, for example a patient not taking trial medication at the correct time


 

Protocol Violation

The act of a patient violating the demands of a protocol. For example, being recruited into a patient even though they do not fulfil the inclusion or exclusion criteria, eg being outside the specified age range.


 

QP release

Document signed by the Qualified Person indicating that a batch of medicinal product is suitable for use


 

Qualified Person (QP)

A person, named on the manufacturing licence with responsibility for the quality of a medicinal product


 

Qualitative Data

These are data which are classified by subjective rather than objective measurement.


 

Quality Adjusted Life Year

A standardised method of assessing health care on the basis of cost and benefit which takes into account both life expectancy and quality of life.


 

Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).


 

Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.


 

Quality of Life

An assessment of the depth as well as the length of life. The quality of life can be assessed at a functional level (eg. social, physical emotional and intellectual activities) and at a perceptual level (eg. the patient’s well being and health status).


 

Quantitative Data

Data measured by objective means and classified by a numerical value


 

Quaque in die (qd)

Four times a day


 

Quarantine

Separation of Investigational Medicinal Product which may not yet be used for the clinical trial.


 

quarter in die sumedus (qds)

Four times a day


 

quater in die (qid)

Four times a day


 

Randomisation

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. Randomisation schedules are often made of blocks (see block) and can be stratified (see stratified) or can be performed using dynamic methods like minimisation (see minimisation).


 

Randomised Controlled Trial (RCT)

Long considered the gold standard for clinical research this is a trial with random allocation to treatment and at least one control group which may be active comparator, placebo or no treatment


 

Rapporteur

A rapporteur in pharmaceutical development refers to a regulatory authority (and individuals thereof) which is appointed or selected to initially review and evaluate a scientific dossier to determine whether a product should be considered suitable to receive a marketing authorisation. In the European regulatory environment one member state may be chosen as the rapporteur to conduct the initial review of the dossier and report their findings to other member states after the initial review. A rapporteur can sometimes be considered as a liaison between a pharmaceutical company and a group of regulatory authorities.


 

Reference Safety Information

A list of the previously recorded adverse reactions seen in clinical trials with the product. This forms the basis for expectedness assessment of adverse reactions and is most commonly found in the Investigators Brochure.


 

Registration trial

A clinical trial required to enable a product to be granted a marketing authorisation, ie one of the trials that is required to demonstrate efficacy and safety prior to the new product being made available for presecribing to patients outside of clinical trials. See Phase I, II and III trials.


 

Regulatory Affairs

The department within a pharmaceutical company that deals with submissions to the regulatory authorities.


 

Regulatory Affairs Manager

The person responsible for managing the regulatory activities of the Regulatory Affairs Department.


 

Regulatory Approval

The approval to undertake a particular process, such as conducting a clinical trial, marketing a product or manufacturing a product.


 

Regulatory Authority

The organisation, usually a government body, which grants approval (e.g. Clinical Trials Authorisation) for a clinical trial to proceed in a country. Examples are the FDA in the US and the MHRA in the UK.


 

Relative Risk

The risk of having a specific event for one treatment group expressed relative to the risk for the comparator group, ie what is the % increase or % decrease in the chance of having an event in one group compared to another.


 

Remote Monitoring

Montoring activities carried out without visiting the investigational site, usually at the sponsor or CRO offices. These activities would include data review, telephone and e-mail contact with site staff, analysis of data trends etc.


 

Request for Information (RFI)

A document asking for specific information about another organisations services. These are used by Pharmaceutical companies to evaluate CROs before asking them to bid on specific projects. RFIs can include information such as financial performance, quality systems, personnel, therapeutic area experience.


 

Request for Proposal (RFP)

When an organisation wants to contract out a piece of work (eg require a CRO to conduct a clinical trial for them) the request for proposal document details the specification, timelines, services required etc. that the company requires the CRO to perform. This information may be sent to many different CROs all of which will use the RFP document to develop their own proposal in an attempt to win the ‘bid’. The proposal document will detail the CROs price, process, personnel etc. and will be submitted to the company to allow them to select who will perform the requested services.


 

Rescue Medication

Medication which may be taken by a patient if the trial drug is not effective in controlling some symptom of the patient’s illness.


 

Research Ethics Committee (REC)

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.


 

Research Nurse

A nurse employed at an investigational site who functions as part of the clinical trial team and is delegated specific tasks by the investigator.


 

Resistance

The failure of a patient to respond to a therapeutic drug. An examples of this is resistance to antibiotic drugs which become ineffective due to genetic mutation and natural selection of bacteria.


 

Responder

A patient who successfully responds to the trial medication


 

Retrospective Trial

A trial where an investigator uses historical data for specific patients to assess aspects of the condition or treatment.


 

Reversible Effect

An effect of a drug which disappears after treatment so that the patient returns to an equivalent state to that before they took the medication.


 

Risk/Benefit Ratio

The balance between the anticipated risks and benefits of conducting the clinical trial. The Regulatory Authorities and Ethics Committees will take the Risk/Benefit ratio into account when deciding whether to approve the trial.


 

Route of Administration

The way in which the medication is given to the subject, for example orally (by mouth); intravenously (by injection into a blood vessel); by inhalation etc.


 

Routine Monitoring Visit

Routine visits that are made by a monitor or CRA to each investigating centre during the subject recruitment phase of the study up until the close of the trial at that site.


 

Run In Period

A treatment free period at the beginning of a study in order to wash out existing treatment. Placebo may be used during this period.


 

Safety

This relates to the incidence of adverse events and in particular the serious adverse events that may be associated with the use of drug treatment.


 

Screening

A process in which an investigator assesses patients for possible entry into a clinical trial. Screening logs can provide useful information in studies where subject recruitment is slower than expected.


 

Seeding

Trials which are conducted exclusively for marketing purposes. They are usually open evaluations which are seldom conducted to GCP standards. These should not be confused with true post-marketing surveillance studies.


 

Self-Assessment Questionnaire

A questionnaire that is completed by a patient as part of a clinical trial.


 

Sequelae

Long term consequences resulting from a particular disease or treatment.


 

Serious Adverse Event (SAE)

Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect


 

Serious Breach

A term used by the MHRA to indicate a deviation from the protocol or GCP which affects subject safety or data quality for clinical trial sites in the UK. The sponsor is required to report these breaches to the MHRA within 7 days regardless of whether the the breach occurs in the UK or in another country


 

Signature Sheet

A sheet which contains sample signatures and initials of all site staff who are involved in the conduct of the trial at that site.


 

Significance Test

The statistical method used to assess how strong the evidence is for a genuine difference in response to treatment.


 

Signs

Physical abnormalities which are found by a doctor on examining a patient.


 

Single Blind Trial

A trial where one party (investigator or patient) is unaware of what treatment the patient is taking.


 

Single Centre Trial

A trial which is only being conducted at one investigational site.


 

Site

The location(s) where trial-related activities are actually conducted.


 

Site Management Organisation (SMO)

An SMO is an organisation that is involved in the recruitment of subjects into a clinical trial. An SMO can be a single centre that recruits subjects and conducts the trial on these subjects or a collection of centres that performs these tasks.


 

Site Specific Assessment

An assessment by an Ethics Committee of the facilities and the capabilities of an investigator and a site to undertake a clinical trial. This may be done by a central or a local Ethics Committee.


 

Site Visit Log

A log which is kept in the investigators site file and which is signed and dated by any member of the clinical research staff who visits the trial centre. It acts as a permanent record of site visits.


 

Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).


 

Source Data Verification (SDV)

The process of comparing entries in the CRF with Source Data to identify and resolve any discrepancies or missing data.


 

Source Data Verification (SDV)

The process of comparing entries in the CRF with Source Data to identify and resolve any discrepancies or missing data.


 

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).


 

Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.


 

Stability Tests

All clinical trial materials are subjected to stability testing under standard conditions. ‘These mimic the stability of the drug in real time. Accelerated stability tests are conducted at elevated temperatures to give information on the likely long term stability of a batch of clinical trial material.


 

Standard Deviation

A measure of how spread out data are. It is calculated by taking the average of the squared distances of each data point from the mean.


 

Standard Medical Treatment

The treatment for a particular condition which is regarded as the standard therapy. These medications are often used as the comparator drug in comparative studies involving new drugs.


 

Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.


 

Statistical Analysis Plan (SAP)

A document detailing the statistical methods to be used to analyse the data from a clinical trial.


 

Statistician

A person who is skilled in the area of statistics


 

Storage Requirements

Specific requirements for storage of IMP., eg. temperature, light and humidity requirements.


 

Stratified Randomisation (Stratification)

A method of randomisation where each strata (eg each centre, or each gender within centre) has an individual randomisation scheme in an attempt to ensure a balance of subjects allocated to each treatment group in a trial.


 

Study Site Coordinator

An appropriately qualified and experienced person nominated by the investigator to assist with the administration of the trial at the investigational site.


 

Subinvestigator

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).


 

Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.


 

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and/or other trial related data.


 

Subjective Measurement

A measurement which depends mainly on individual judgement.


 

Sublingual

Medication given under the tongue.


 

Summary of Product Characteristics (SMPC)

Document which provides summary information about a marketed medicine for prescribing purposes


 

Supportive Data

Information on the efficacy and safety of a drug which has been generated in a non-pivotal trial.


 

Suspected Serious Adverse Reaction (SSAR)

An Adverse Event which fulfills one or more of the criteria for a serious event and which is suspected to have a causal relationship with the medication


 

Suspected Unexpected Serious Adverse Reaction (SUSAR)

An adverse event which fulfills the criteria for a serious adverse event, is suspected to have a causal relationship with the medication, and the nature, or severity of which is not consistent with the applicable product information (e.g. investigator’s brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).


 

Symptom

A physical or mental disturbance which occurs in a patient, and indicates the presence of a disease


 

ter die sumendus (tds)

Three times a day


 

Test Article

Another name for the drug or device that is being tested in a clinical trial.


 

Therapeutic Area

Conditions associated with a particular body system. For example, the cardiovascular therapeutic area is the one that is concerned with the treatment of conditions associated with the cardiovascular system, such as heart disease, angina, hypertension etc.


 

Time Point (Timepoint)

A prescribed time in a clinical trial that a specific measurement should be taken. For example, blood pressure should be measured on each subject at 3 weeks after randomisation, in this case this the timepoint is 3 weeks.


 

Tolerance

A reduction in the therapeutic response to a drug in a patient who has been treated continuously with the medication.


 

Topical

Medications given via the skin, usually in the form of a cream, lotion or patch.


 

Toxicity

Any adverse effect produced by a drug which is detrimental to health.


 

Transdermal Patch

Patch, applied to the skin which delivers medication which is then absorbed through the skin.


 

Trial Initiation

The point at which an investigator can start to enter patients into a clinical trial as all the pretrial procedures have been completed satisfactorily, and all essential regulatory documentation is in place.


 

Trial Master File

A copy of all the documentation relating to a clinical trial which contains the essential documents listed in chapter 8 of ICH GCP.  The TMF can be paper based, electronic or a combination of the two.  The term TMF in ICH GCP covers both the sponsor and investigator files, but in practice the term is often used to refer to the sponsor files and the term Investigator Site File is used to refer to the files held at the investigational site.


 

Trial Number

The unique number which will identify the trial unambiguously


 

Type I Error

An error that is made when a correct null hypothesis is rejected.


 

Type II Error

An error that is made when an incorrect null hypothesis is not rejected.


 

UK Ethics Committee Authority (UKECA)

A UK government body with legal responsibility for the operation, recognition and governance of UK Research Ethics Committees.


 

Unblinding

Revealing which medication a subject has been assigned during a blinded clinical trial. This is usually done in an emergency when the treatment of the emergency is dependent on knowing which treatment the subject has been taking.


 

Unexpected Adverse Reaction

An adverse reaction, the nature, or severity of which is not consistent with the applicable product information (e.g. investigator’s brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).


 

Unrestricted Randomisation

A method of randomisation that does not use blocks. This could lead to an imbalance in the number of patients in each treatment group especially in small trials.


 

Validation of computerized systems

A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results


 

Variance

The square of the standard deviation. A measure of variability (ie how spread out is the data)


 

Verification of Data

The procedures carried out to ensure that the data contained in the final clinical trial report (Final Report) match the original observations. These procedures may apply to raw data, hard copy or electronic CRFs, computer print-outs and statistical analyses and tables (cf. Audit, Inspection, Quality Control)


 

Visit

In a clinical trial that requires a patient/subject to attend the site/centre on numerous occasions each separate attendance is referred to as a visit.


 

Visual Analogue Scale (VAS)

A scale which is used to provide quantitative measures of subjective parameters. A VAS usually consists of a 10cm line, with definitions attached to each of the two ends, on which the subject places a mark to indicate their perception of that particular parameter.


 

Volunteer

A subject, usually a normal, healthy male, participating in a Phase I clinical trial.


 

Vulnerable Subjects

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory
personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.


 

Washout Period

The period before a clinical trial or between two active treatments during which time the patient receives either no medication or a placebo. The purpose of a wash-out period is to allow the previous treatment to be excreted and prevent carry over effects in the next treatment phase.


 

Well-being (of the trial subjects)

The physical and mental integrity of the subjects participating in a clinical trial.


 

Withdrawals

The patients who are withdrawn from clinical studies by the investigator due to the presence of intolerable adverse effects, lack of efficacy or poor compliance with the trial protocol.


 

Witnessed Verbal Consent

If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed and personally dated the informed consent form, the witness should sign and personally date the consent form. By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject’s legally acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.


 

World Medical Association (WMA)

Association of physicians who publish and amend the Declaration of Helsinki


 

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