Speak the Language of Clinical Research: A Comprehensive Glossary of Common Acronyms and Definitions

The clinical research industry is a complex and constantly evolving field that can be daunting for those who are new to it. In addition to the technical and scientific knowledge required, the industry also has its own language, with acronyms and unique words that may be unfamiliar to newcomers. For individuals who are not yet familiar with these terms, navigating the clinical research industry can be challenging. Understanding the terminology used in clinical research is critical for effective communication and successful collaboration between various stakeholders.

In this article, we will discuss some of the most commonly used acronyms and terms in the clinical research industry, providing a useful guide for those new to this field.

clinical research project management

1571 FDA Form: A document that is required by the US Food and Drug Administration (FDA) for the submission of an Investigational New Drug (IND) application that provides information about the drug being tested, including its chemical composition, proposed clinical trial protocol, and information about the sponsor of the clinical trial.

1572 FDA Form: A form that must be filed by all investigators participating in a clinical trial that states the requirements and expectations of the US Food and Drug Administration (FDA) for the Principal Investigator (PI) and their oversight of the trial at their site.

ACRP: Association of Clinical Research Professionals. A nonprofit organization that represents the clinical research profession, with a mission to promote excellence in clinical research.

ACRPM: Association of Clinical Research Project Managers. A global professional organization dedicated to uniting clinical research professionals who employ project management tools and methodologies to ensure the successful completion of project deliverables on time and within budget.

ADR: Adverse Drug Reaction. An undesirable or harmful reaction resulting from the administration of a drug, typically occurring during a clinical trial or after a drug’s approval.

AE: Adverse Event. An unintended, harmful, or undesirable event or reaction experienced by a participant during a clinical trial, whether or not it is related to the investigational treatment.

AECA: Adverse Event of Clinical Interest. An adverse event identified prior to the clinical trial that warrants close monitoring and reporting due to its potential association with the investigational product or the patient population.

AESI: Adverse Events of Special Interest. Specific adverse events that are carefully monitored and reported during a clinical trial due to their potential significance or association with the investigational product.

ALCOA: Attributable, Legible, Contemporaneous, Original, and Accurate. A set of principles for ensuring that clinical trial data is reliable and of high quality.

Audit: A systematic and independent review of trial-related activities and documents to assess the compliance of a clinical trial with the study protocol, regulatory requirements, and good clinical practice (GCP) guidelines.

BIMO: Bioresearch Monitoring Program. A program run by the FDA to ensure the safety and protection of participants, data integrity, and compliance with regulatory requirements in clinical trials and nonclinical research.

BLA: Biologics License Application. A submission made to the FDA to request approval for a new biologic product after successful completion of clinical trials.

Blinding: A technique used in clinical trials to prevent bias by keeping either the participants, the investigators, or both unaware of the treatment assignment.

Break Blind: The unblinding of a clinical trial, which means revealing the treatment assignments to the study participants, investigators, or others involved in the trial who were previously blinded to the information.

CBER: Center for Biologics Evaluation and Research. An FDA center responsible for regulating biologic products, including vaccines, blood products, and gene therapies.

CDER: Center for Drug Evaluation and Research. An FDA center responsible for regulating prescription and over-the-counter drugs, including new drug applications and generic drug approvals.

CI: Confidence Interval. A range of values within which a population parameter is estimated to fall, with a specific level of confidence.

CIOMS: Council for International Organizations of Medical Sciences. An international organization that develops and promotes global standards and guidelines for the pharmaceutical industry, focusing on drug safety, pharmacovigilance, and ethical considerations in clinical research.

cIRB: Central Institutional Review Board. A type of Institutional Review Board (IRB) that provides a centralized review of the ethics and protocol compliance of clinical trials, instead of relying on local IRBs at individual sites.

Clinical Trial: A research study that is conducted in humans to evaluate the safety and effectiveness of a new drug or medical device.

CMP: Clinical Monitoring Plan. A document that outlines the monitoring activities that will be performed during a clinical trial to ensure the safety and well-being of participants, data integrity, and protocol compliance.

CRF: Case Report Form. A standardized document used to collect and record data from each participant in a clinical trial, ensuring that the data is consistent and accurate.

CRO: Contract Research Organization. A company that provides research services, such as clinical trial management, on behalf of pharmaceutical or biotechnology companies.

CSR: Clinical Study Report. A comprehensive document that summarizes the methods, results, and conclusions of a clinical trial, often submitted to regulatory authorities as part of a drug or biologic approval process.

CTA: Clinical Trial Agreement. A legal contract between a sponsor and a clinical trial site, outlining the responsibilities, rights, and obligations of each party during the study.

CTCAE: Common Terminology Criteria for Adverse Events. A standardized system used by clinical trial researchers and healthcare professionals to classify and grade the severity of adverse events (AEs) that occur in participants during a clinical trial.

CTD: Common Technical Document. A standardized format for submitting clinical and non-clinical data to regulatory authorities, such as the FDA and EMA, to support the registration of a new drug or biologic.

CTMS: Clinical Trial Management System. A software system used to manage, track, and report on clinical trials, including patient data, site management, and study progress.

Data monitoring committee (DMC): An independent group of experts who review the data from a clinical trial to ensure the safety of participants and the validity of the trial results.

Declaration of Helsinki: The Declaration of Helsinki is a statement of ethical principles for medical research involving human subjects by providing guidelines for researchers to follow when conducting clinical trials or other research involving human subjects.

DIA: Drug Information Association. A global nonprofit organization that provides a platform for collaboration and education in the life sciences industry.

DLT: Dose-Limiting Toxicity. An undesirable side effect or adverse event that occurs at a specific dose level of an investigational drug, limiting the ability to increase the dose further in a clinical trial.

DMC: Data Monitoring Committee. An alternative term for a Data Safety Monitoring Board (DSMB), an independent group of experts that reviews and monitors the safety and efficacy data of a clinical trial to ensure the ongoing protection of participants.

Dose Escalation: The gradual increase of the dose of an investigational product to evaluate its safety and efficacy.

Double Blind Clinical Trial: A double-blind clinical trial is a type of clinical trial in which neither the participants nor the investigators know which treatment group the participants are in. In a double-blind trial, the participants are randomly assigned to receive either the investigational treatment or a control treatment, which may be a placebo or an existing standard of care.

DSMB: Data Safety Monitoring Board. An independent group of experts that reviews and monitors the safety and efficacy data of a clinical trial to ensure the ongoing protection of participants.

eCRF: Electronic Case Report Form. An electronic version of the traditional paper CRF, used to collect and store clinical trial data in an electronic format for more efficient data management and analysis.

EDC: Electronic Data Capture. A technology used to collect and store clinical trial data electronically, improving the accuracy and efficiency of data management.

Efficacy: The ability of an investigational product to produce the intended beneficial effect in a clinical trial.

eISF: Electronic Investigator Site File. A collection of essential documents stored electronically that contains information related to the conduct of a clinical trial that are maintained by the investigator or site personnel responsible for conducting the trial at a specific site.

eISF Reference Model: Electronic Investigator Site File Reference Model. A standard framework for the organization and content of electronic ISFs, which helps to ensure consistency and completeness across different clinical trials.

EMA: European Medicines Agency. The European Union’s regulatory agency responsible for the evaluation, supervision, and monitoring of medicines, including the approval of new drugs and biologics.

Endpoint: The outcome measure that is used to determine the effectiveness of the investigational product in a clinical trial.

Endpoint Adjudication: The process of independent review of clinical endpoint events to determine if they meet the criteria for inclusion in the final analysis.

ePRO: Electronic Patient-Reported Outcome. A digital tool or platform used to collect patient-reported outcome data in a clinical trial, allowing for more accurate and efficient data collection.

eTMF: Electronic Trial Master File. A digital version of the Trial Master File, used to store, manage, and access essential clinical trial documents electronically.

FDA: Food and Drug Administration. The U.S. regulatory agency responsible for ensuring the safety and effectiveness of drugs, biologics, medical devices, and other healthcare products.

GCP: Good Clinical Practice. A set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects.

HIPAA: Health Insurance Portability and Accountability Act. A U.S. law that establishes national standards for the privacy and security of protected health information, including in the context of clinical trials.

HREC: Human Research Ethics Committee. An independent ethics committee responsible for reviewing and approving clinical research protocols to ensure the protection and welfare of human subjects, similar to an IRB but often used in countries outside the United States.

ICD: Informed Consent Document. A document provided to potential clinical trial participants that explains the purpose, procedures, risks, and benefits of the trial, as well as their rights and responsibilities as a participant.

ICF: Informed Consent Form. A document provided to potential clinical trial participants that explains the purpose, procedures, risks, and benefits of the trial, as well as their rights and responsibilities as a participant.

ICH: International Council for Harmonisation. An international organization that develops and promotes global standards and guidelines for the pharmaceutical industry, including clinical trials.

IDE: Investigational Device Exemption. An approval granted by regulatory authorities, such as the FDA, that allows a medical device to be used in a clinical trial to gather safety and efficacy data.

IEC: Independent Ethics Committee. Another term for an Institutional Review Board (IRB) or Human Research Ethics Committee (HREC), responsible for reviewing and approving clinical research protocols to ensure the protection and welfare of human subjects. IECs are more common in ex-U.S. countries, for the U.S. you will typically see IRB rather than IEC.

IEC: Investigational Event Committee. An independent committee of clinical experts who review and adjudicate clinical events (e.g., cardiovascular events, bleeding events) in a clinical trial to ensure consistent and unbiased event classification.

IMP: Investigational Medicinal Product. An alternative term for the Investigational Product, the drug, biologic, or medical device being studied in a clinical trial.

IMPD: Investigational Medicinal Product Dossier. A comprehensive set of documents submitted to regulatory authorities that provides information on the quality, manufacturing, and control of the investigational medicinal product (IMP), as well as data from nonclinical studies and previous clinical trials.

IND: Investigational New Drug. An application submitted to regulatory authorities, such as the FDA, seeking permission to conduct clinical trials for a new drug or biologic.

Individual Case Safety Reports (ICSRs). Reports that contain detailed information about individual cases of adverse events or reactions, submitted by healthcare professionals, pharmaceutical companies, and regulatory authorities to support post-marketing drug safety monitoring and pharmacovigilance.

Informed Consent: The process by which a participant is informed of the purpose, risks, and benefits of participating in a clinical trial, and agrees to participate voluntarily.

Interim analysis: An analysis of the data from a clinical trial that is conducted before the trial is complete, to evaluate the safety and efficacy of the investigational product.

IP: Investigational Product. The drug, biologic, or medical device being studied in a clinical trial.

IRB: Institutional Review Board. An independent ethics committee responsible for reviewing and approving clinical research protocols to ensure the protection and welfare of human subjects.

ISF: Investigator Site File. A collection of essential documents and information related to the conduct of a clinical trial that are maintained by the investigator or site personnel responsible for conducting the trial at a specific site.

ITT: Intention-to-Treat. An analysis approach in which all participants in a clinical trial are included in the final analysis, regardless of whether they completed the study or followed the protocol.

IVRS/IWRS: Interactive Voice/Web Response System. A technology used in clinical trials to automate and manage randomization, drug supply, and other study-related tasks.

MedDRA: Medical Dictionary for Regulatory Activities. A standardized medical terminology used by regulatory authorities and the pharmaceutical industry for data entry, retrieval, and analysis during the drug development process.

MHRA: Medicines and Healthcare products Regulatory Agency. The United Kingdom’s regulatory agency responsible for ensuring the safety and effectiveness of medicines, medical devices, and other healthcare products.

Monitoring: The process of overseeing the conduct of a clinical trial to ensure compliance with the protocol, regulations, and ethical standards.

MTD: Maximum Tolerated Dose. The highest dose of an investigational drug that can be administered without causing unacceptable side effects, often determined during early-phase clinical trials.

NCI-CTCAE: National Cancer Institute-Common Terminology Criteria for Adverse Events. A standardized classification system developed by the National Cancer Institute for reporting adverse events in cancer clinical trials, providing a common language for researchers to describe the severity of events consistently.

NDA: New Drug Application. A submission made to regulatory authorities, such as the FDA, to request approval for a new drug or biologic after successful completion of clinical trials.

PD: Pharmacodynamics. The study of the biochemical and physiological effects of a drug on the body and the mechanisms by which those effects are produced.

PDUFA: Prescription Drug User Fee Act. A law that allows the FDA to collect fees from drug manufacturers to fund the review and approval process for new drugs.

PI: Principal Investigator. The lead researcher responsible for the overall design, conduct, and management of a clinical trial.

PIP: Pediatric Investigation Plan. A development plan aimed at ensuring that the necessary data is obtained through studies in children to support the authorization of a medicinal product for pediatric use.

PIVOTAL trial: Pivotal Clinical Trial. A large-scale, late-phase clinical trial that provides the primary evidence for the safety and efficacy of a drug or medical device, which is then used by regulatory authorities to decide whether to approve it for marketing.

PK: Pharmacokinetics. The study of how a drug is absorbed distributed, metabolized, and excreted by the body. PK studies are conducted to determine the pharmacokinetic properties of a drug, such as its bioavailability, half-life, and clearance rate.

Placebo: A substance that looks like the investigational product but does not contain any active ingredients, used in a clinical trial as a control.

PP: Per Protocol. An analysis approach in which only participants who completed the clinical trial and followed the protocol as planned are included in the final analysis.

PRA: Patient-Reported Adherence. A measurement of a patient’s adherence to a prescribed treatment regimen, as reported directly by the patient, without interpretation by a healthcare professional.

PRO: Patient-Reported Outcome. A measurement of a patient’s health status, symptoms, or quality of life, as reported directly by the patient, without interpretation by a healthcare professional (usually in the form of a study diary).

Protocol: A detailed plan that outlines the design, objectives, methodology, and statistical analysis of a clinical trial.

PSUR: Periodic Safety Update Report. A comprehensive report submitted periodically to regulatory authorities during the post-marketing phase of a drug, providing an updated evaluation of its safety profile.

QoL: Quality of Life Survey. A multidimensional concept that evaluates a person’s physical, mental, and social well-being, often used as an outcome measure in clinical trials.

Randomization: The process by which participants are assigned to different treatment groups in a clinical trial using a random method.

Randomization Code: A unique code that is used to assign participants to different treatment groups in a clinical trial.

RBM: Risk Based Monitoring. A strategy for monitoring clinical trials that focuses on identifying and managing the most critical risks to the trial’s objectives and to the safety and well-being of the participants. With RBM, the monitoring strategy is tailored to the specific risks associated with the clinical trial. This involves identifying the critical data elements that are most important to the trial objectives, as well as the potential risks associated with those elements.

RCT: Randomized Controlled Trial. A study design in which participants are randomly assigned to receive either the experimental treatment or a control (placebo or standard treatment), minimizing biases and ensuring the validity of the results.

RDE: Remote Data Entry. A process in which clinical trial data is entered directly into an electronic data capture (EDC) system at the study site, allowing for real-time data access and monitoring.

RECIST: Response Evaluation Criteria in Solid Tumors. A set of standardized criteria used to assess tumor response to treatment in clinical trials, helping to ensure consistency in the evaluation of treatment outcomes.

RTSM: Randomization and Trial Supply Management. A technology system used in clinical trials to manage patient randomization, drug supply, and other study-related tasks, which may include an Interactive Voice/Web Response System (IVRS/IWRS).

SADR: Serious Adverse Drug Reaction. A serious adverse reaction that is suspected to be related to the use of a drug or biologic, resulting in significant risks to the patient’s health, such as death, life-threatening events, or hospitalization.

SAE/AE reconciliation: Serious Adverse Event/Adverse Event Reconciliation. A process of comparing and reconciling the serious adverse event and adverse event data reported in a clinical trial to ensure accuracy and completeness.

SAE: Serious Adverse Event. An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent or significant disability or incapacity, or leads to a congenital anomaly or birth defect.

SAP: Statistical Analysis Plan. A comprehensive document that outlines the statistical methods, data handling procedures, and planned analyses for a clinical trial.

SC: Steering Committee. A group of experts and stakeholders responsible for overseeing the strategic direction, management, and decision-making in a clinical trial or research program.

SDR: Source Data Review. A re­view of source documentation to check quality of source, review pro­tocol compliance and ensure criti­cal processes and source documen­tation are adequate. This does not typically include a review of the source data against CRF (case report form) data.

SDV: Source Data Verification. A process of verifying that the data collected and reported in a clinical trial accurately reflects the original source data (e.g., medical records, laboratory results, etc.).

Single-Blind Clinical Trial: A single-blind clinical trial is a type of clinical trial in which either the participants or the investigators are blinded to the treatment group assignment, but not both. In a single-blind trial, the participants are randomly assigned to receive either the investigational treatment or a control treatment, which may be a placebo or an existing standard of care.

SIV: Site Initiation Visit. A meeting conducted by the sponsor or CRO at a clinical trial site before the study begins to ensure that the site is prepared and equipped to conduct the trial according to the protocol and regulatory requirements.

SOC: System Organ Class. A classification system used in MedDRA to group adverse events by the organ system or physiological system affected.

SOCRA: Society of Clinical Research Associates. A non-profit, international organization that represents clinical research professionals, including clinical research coordinators, investigators, project managers, and regulatory professionals.

SOP: Standard Operating Procedure. A set of written instructions that document a routine or repetitive activity, ensuring that clinical trials are conducted consistently and in compliance with regulations.

SPIRIT: Standard Protocol Items. Recommendations for Interventional Trials A set of guidelines and recommendations for the content of clinical trial protocols, aimed at improving the quality and completeness of study documentation.

Stopping Rules: Predefined criteria that are used to make decisions about the early termination or continuation of a clinical trial that are put in place to ensure the safety of study participants and the validity of trial results.

SUSAR: Suspected Unexpected Serious Adverse Reaction. A serious adverse reaction that is both unexpected (not consistent with the known safety profile of the drug) and suspected to be related to the investigational drug.

TGA: Therapeutic Goods Administration. The Australian regulatory agency responsible for the evaluation, supervision, and monitoring of therapeutic goods, including the approval of new drugs and biologics.

TLF: Tables, Listings, and Figures. A set of data summaries and visualizations that are generated during the statistical analysis and reporting of clinical trial results, providing a comprehensive view of the study outcomes.

TMF: Trial Master File. A collection of essential documents that demonstrates the proper conduct of a clinical trial and the quality of the data generated, used for regulatory inspection and audit purposes.

TMF Reference Model:  Trial Master File Reference Model. A standard developed by the Drug Information Association (DIA) for the organization and management of Trial Master Files (TMFs) in clinical trials.

Treatment arm: One of the different groups of participants in a clinical trial who are receiving different treatments or doses of an investigational product.

TQT: Thorough QT/QTc Study. A clinical trial designed to assess the effect of a new drug on the QT/QTc interval, an electrocardiogram measurement used to evaluate the potential risk of cardiac arrhythmias.

UAT: User Acceptance Testing. A process in which clinical trial software or systems are tested by end-users to ensure that they meet the necessary requirements and function as intended in a real-world setting.

VHP: Voluntary Harmonization Procedure. A coordinated assessment process for multinational clinical trials in the European Union, which aims to streamline and harmonize the clinical trial authorization process across participating countries.

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