Adverse Event (AE)

Any untoward medical occurrence that happens to a trial participant during the course of a clinical trial, regardless of whether it is related to the study treatment. (See also, Safety Management)

Allied Health Professionals (AHPs)

People who work in health care professions distinct from dentistry, nursing, medicine, and pharmacy. They provide a range of diagnostic, technical, therapeutic, and support services in connection with health care, for example, occupational therapists, dietitians, and podiatrists.

Association of the British Pharmaceutical Industry (ABPI)

A trade association for UK pharmaceutical companies.

Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA)

The five principles of data integrity. By embracing these principles across a company’s data management system, businesses can ensure that the data they’re collecting is accurate and that outlined processes are being correctly followed.

Biomedical Research Centres (BRCs)

Collaborations between world-leading universities and NHS organisations that bring together academics and clinicians to translate lab-based scientific breakthroughs into potential new treatments, diagnostics, and medical technologies.

Case Report Form (CRF)

A standardised document used to collect specific data required for the clinical trial, including participant demographics, medical history, treatment information, and study outcomes. (See also, Clinical Writing)

Clinical Research Associate (CRA)

A healthcare professional who helps to organise and monitor the different phases of clinical trials.

Clinical Research Committee (CRC)

The Clinical Research Committee oversees funding and endorsement of investigator-led clinical trials, and other research supporting or enabling clinical trials.

Clinical Research Facilities (CRFs)

Purpose built facilities in NHS hospitals where researchers can deliver early-phase and complex studies.

Clinical Research Nurse (CRN)

A specialised healthcare professional who provides patient-centred care during clinical trials.

Clinical Study

A scientific investigation involving human participants that aims to evaluate the safety, efficacy, or effectiveness of a medical intervention.

Clinical Study Report (CSR)

A document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study. (See also, Clinical Writing)

Clinical Trial

A research study that evaluates the safety and effectiveness of new drugs, treatments, or medical devices in humans.

Clinical Trial Authorisation (CTA)

The approval granted by the regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA), to conduct a clinical trial in the UK.

Clinical Trial Co-ordinator (CTC)

A healthcare professional that supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start-up to study closure

Clinical Trial Management System (CTMS)

A software system used to manage and track clinical research activities within an institution.

Clinical Trials Units (CTUs)

Specialist units with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. The NIHR provides support funding for a number of UKCRC registered units.

Clinical Trial of an Investigational Medicinal Product (CTIMP)

A clinical trial that involves testing an investigational medicinal product, which can be a drug, vaccine, or medical device, to evaluate its safety and efficacy.

Co-Investigator (CI)

A senior or key investigator involved in a clinical study who does not have the overall responsibility and authority of the Principal Investigator (PI).

Contract Research Organisation (CRO)

An organisation that provides support services to the pharmaceutical and biotechnology industries in conducting clinical trials, such as project management, monitoring, data management, and statistical analysis. (See also, About PHARMExcel)

Control Group

A group separated from the rest of the experiment such that the independent variable being tested cannot influence the results.

Corrective and Preventive Action (CAPA)

Corrective and preventive action consists of improvements to an organisation’s processes taken to eliminate causes of non-conformities or other undesirable situations. (See also, Study/Project Management)

Data Safety Monitoring Board (DSMB)

An independent committee appointed by the sponsor to periodically review the safety and efficacy data during a clinical trial and provide recommendations regarding the trial continuation or modifications. (See also, Biostatistics)


A study design in which neither the participants nor the researchers know which treatment the participant is receiving.


The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. Phase II clinical trials gauge efficacy, and Phase III trials confirm it.

Electronic Case Report Form (eCRF)

The digital version of a paper-based case report form. (See also, Clinical Writing)

Electronic Data Capture (EDC)

The use of electronic systems to collect, manage, and store clinical trial data, replacing traditional paper-based methods. (See also, Data Management)

Electronic Health Record (EHR)

An electronic version of a patients medical history, that is maintained by the provider over time, and may include all of the key administrative clinical data relevant to that persons care under a particular provider.

Electronic Trial Master File (eTMF)

An electronic version of a Trial Master File. (See also, Clinical Writing)


A specific outcome or measure used to evaluate the effectiveness of a treatment or intervention in a clinical trial.


The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.

Ethics Committee

A body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.

Exclusion Criteria

The characteristics or conditions that disqualify individuals from participating in a clinical trial.

First in Human (FIH)

A study during which a drug is administered to humans for the first time.

Food and Drug Administration (FDA)

The regulatory agency responsible for protecting public health by ensuring the safety and efficacy of drugs, vaccines, and medical devices in the United States.


A branch of medicine focused on the digestive system and its disorders. (See also, Gastroenterology/Inflammatory Bowel Diseases)

Good Clinical Practice (GCP)

A set of ethical and scientific standards that ensure the design, conduct, and reporting of clinical trials are consistent and protect the rights, safety, and well-being of trial participants. (See also, Study/Project Management)

Good Documentation Practice (GDP)

A set of guidelines that dictate how to record raw data entries. (See also, Study/Project Management)

Good Laboratory Practice (GLP)

A quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development. (See also, Study/Project Management)

Good Manufacturing Practice (GMP)

A system for ensuring that products are consistently produced and controlled according to quality standards. (See also, Study/Project Management)

Good Pharmacovigilance Practice (GVP)

A quality standard for monitoring the safety of medicines and if necessary, taking action to reduce the risks and increase the benefits of medicines. (See also, Study/Project Management)


A branch of medicine concerned with the study of the cause, prognosis, treatment, and prevention of diseases related to blood. (See also, Oncology/Haematology)


A branch of medicine concerned with the study, prevention, diagnosis, and management of diseases that affect the liver, gallbladder, biliary tree, and pancreas. (See also, Hepatology)

Inclusion Criteria

The characteristics or conditions that participants must have to be eligible for enrolment in a clinical trial.

Individual Participant Data (IPD)

The data collected from each individual participant in a clinical trial, which is anonymised and used for analysis and reporting. (See also, Data Management)

Infectious Diseases

Disorders caused by organisms such as bacteria, viruses, fungi or parasites. (See also, Infectious Diseases and Vaccines)

Inflammatory Bowel Diseases (IBD)

A term for two conditions (Crohn’s disease and ulcerative colitis) that are characterized by chronic inflammation of the gastrointestinal (GI) tract. (See also, Gastroenterology/Inflammatory Bowel Diseases)

Institutional Review Board (IRB)

An independent committee that reviews and approves the ethical aspects of a clinical trial before it can begin.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

An international organisation that develops and promotes harmonised guidelines for pharmaceuticals, including guidelines on good clinical practice (GCP) and other regulatory aspects.

International Organisation for Standardisation (ISO)

An independent, non-governmental, international organisation that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. (See also, ISO 9001 Quality Management)


The person responsible for conducting a clinical trial, including recruiting participants, collecting data, and overseeing the study.

Investigational Medicinal Product

Investigational Medicinal Product – A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.

Investigational New Drug (IND)

A regulatory submission to the FDA providing information about a new drug before it can be tested in humans.

Investigator Site File (ISF)

A file containing essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements throughout the clinical trial. (See also, Clinical Writing)

Medicines and Healthcare products Regulatory Agency (MHRA)

The UK regulatory authority responsible for ensuring the safety, quality, and efficacy of medicines and medical devices, including overseeing clinical trials. (See also, MHRA Corporate Plan 2023-2026)

Medical Device

Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.


The process of overseeing a clinical trial to ensure participant safety, data integrity, and protocol adherence. (See also, Monitoring)

National Health Service (NHS)

Government-funded medical and health care services that everyone living in the UK can use without being asked to pay the full cost of the service.

National Institute for Health and Care Research (NIHR)

The British government’s major funder of clinical, public health, social care, and translational research.

National Institute for Health and Clinical Excellence (NICE)

Makes recommendations on which treatments should be provided by the NHS.

Observational Study

An investigation of health outcomes amongst groups of people in the course of their everyday life at home, work, or the doctor’s office, where assignment of treatments or other procedures is as part of their regular medical care.


A branch of science concerned with tumours and cancers. (See also, Oncology/Haematology)


A branch of medicine and surgery which deals with the diagnosis and treatment of eye disorders. (See also, Ophthalmology)

Out of Specification (OOS)

A term used to describe a result that does not meet predefined acceptance criteria or falls outside the expected range, requiring investigation to determine its significance for the clinical trial.

Participant Information Sheet (PIS)

A document that provides potential trial participants with a concise summary of the key information about the trial, including its purpose, procedures, risks, benefits, and their rights. (See also, Clinical Writing)

Phase I

The initial stage of clinical trials that primarily focuses on assessing the safety, dosage, and side effects of a new treatment in a small group of healthy volunteers or patients.

Phase II

The second stage of clinical trials that involves a larger group of participants to further evaluate the safety and effectiveness of a treatment, as well as to determine optimal dosing.

Phase III

The third stage of clinical trials that involves a larger population to confirm the effectiveness of a treatment, monitor side effects, and compare it to existing standard treatments.

Phase IV

The post-marketing phase of clinical trials that occur after a treatment has been approved by regulatory authorities, focusing on long-term safety, effectiveness, and real-world usage.


Different stages of clinical trials that evaluate a treatment’s safety, efficacy, and side effects before it can be approved for widespread use. Phase I focuses on initial safety in a small group, Phase II evaluates efficacy and side effects in a larger group, Phase III compares the treatment to existing standards, and Phase IV involves post-marketing surveillance.


An inactive substance or treatment given to some participants in a clinical trial, often used as a control group for comparison.

Pre-Study Qualification Visit

A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped to run a specific clinical trial. (See also, Study/Project Management)

Principal Investigator (PI)

The person responsible for the overall conduct of a clinical trial at a study site, including participant recruitment, data collection, and ensuring compliance with the protocol and regulatory requirements.


Live bacteria and yeasts promoted as having various health benefits (See also, Probiotics)


A detailed plan that outlines the objectives, design, methodology, and analysis of a clinical trial. (See also, Clinical Writing)


Detailed subjective evaluation, used to capture views of individuals’ and groups.

Quality Assurance (QA)

Systematic activities implemented to ensure that the clinical trial is conducted, and data are generated, recorded, analysed, and reported in compliance with applicable regulations, guidelines, and standards. (See also, Quality and Compliance)

Quality Control (QC)

Activities and procedures undertaken to ensure that the products, processes, and data generated during a clinical trial meet defined quality standards. (See also, ISO 9001 Quality Management)


Numerical evaluation of an intervention.


The process of assigning participants to different treatment groups in a clinical trial randomly, to minimise bias and ensure fairness.

Research and Development (R&D)

The process of scientific investigation, testing, and development of new drugs, therapies, or medical devices.

Research Ethics Committee (REC)

An independent committee that reviews and approves the ethical aspects of a clinical trial protocol and ensures the rights, safety, and well-being of trial participants are protected.

Research Site Initiation (RSOI)

The process of preparing and organising a research site for the initiation of a clinical trial, including obtaining necessary approvals, setting up infrastructure, and training site staff. (See also, Study/Project Management)

Risk Based Monitoring

The process of ensuring the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study. (See also, Study/Project Management)

Risk Management Plan (RMP)

A document that outlines the strategies and procedures to identify, assess, minimise, and communicate the risks associated with the use of a medicinal product in a clinical trial or post-approval. (See also, Clinical Writing)

Root Cause Analysis

The process of discovering the root causes of problems in order to identify appropriate solutions. (See also, Study/Project Management)

Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. (See also, Safety Management)

Side Effects

Any undesired actions or effects of a drug or treatment.


A study design in which the participants do not know which treatment they are receiving, but the researcher does.

Site Initiation Visit (SIV)

A meeting between the sponsor, investigator, and study site staff to initiate a clinical trial at a particular site, ensuring that the site is ready to start enrolling participants and following the protocol. (See also, Study/Project Management)

Site Master File

The file held by the site Principal Investigator containing the essential documents that demonstrate that the trial has been conducted in accordance with regulatory requirements and ICH GCP, enabling both the conduct of a clinical trial and the quality of the data produced to be evaluated. (See also, Clinical Writing)

Site Qualification Visit

A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped to run a specific clinical trial. (See also, Study/Project Management)

Site Selection Visit

A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped to run a specific clinical trial. (See also, Study/Project Management)

Standard of Care

The medical treatment that is normally provided to people with a given condition.

Standard Operating Procedure (SOP)

Detailed written instructions that describe the steps and processes to be followed in conducting various aspects of a clinical trial, ensuring consistency and compliance. (See also, Clinical Writing)

Statistically Significant

A result that is unlikely to have happened by chance.

Summary of Product Characteristics (SPC)

A document that provides comprehensive and up-to-date information about a medicinal product, including its indications, contraindications, dosage, adverse reactions, and precautions. (See also, Clinical Writing)

Suspected Unexpected Serious Adverse Reaction (SUSAR)

A serious adverse reaction that is unexpected based on the known safety profile of the investigational medicinal product and needs to be reported to regulatory authorities. (See also, Safety Management)

Trial Master File (TMF)

A comprehensive collection of essential documents that provides a complete and accurate record of a clinical trial, including the protocol, investigator brochure, informed consent forms, monitoring reports, and regulatory correspondence. (See also, Clinical Writing)


A preparation that is used to stimulate the body’s immune response against diseases. (See also, Infectious Diseases and Vaccines)


Information collected during a clinical trial either from direct or indirect data.

World Health Organization (WHO)

A specialised agency of the United Nations responsible for international public health.