The Ultimate PHARMExcel Glossary of Clinical Trials

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)

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.

A trade association for UK pharmaceutical companies.

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.

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.

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)

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

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

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

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

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

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)

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

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.

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

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

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.

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.

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

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)

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

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)

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.

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

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

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.

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.

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.

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

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

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)

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)

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

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)

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

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)

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

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

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

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)

A process where participants in a clinical trial are provided with detailed information about the study and voluntarily agree to participate.

A document that provides potential trial participants with detailed information about the study, including its purpose, procedures, risks, benefits, and their rights, and allows them to voluntarily provide their informed consent to participate. (See also, Clinical Writing)

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

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

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

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

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)

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)

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)

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.

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

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

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)

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.

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)

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.

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.

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.

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.

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)

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.

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)

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.

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

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.

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)

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)

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)

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

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)

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.

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)

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)

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)

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)

The organisation or individual responsible for initiating, managing, and financing a clinical trial.

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

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)

A result that is unlikely to have happened by chance.

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)

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)

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.

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