Decoding the Alphabet Soup: A Guide to Clinical Research Acronyms
The life sciences industry, like many others, uses a proliferating alphabet soup of acronyms to communicate about processes and technology. At this point there are so many that even industry insiders have a difficult time keeping up with the growing number of acronyms needed to be memorized and understood. Within the industry, the clinical trials world and particularly eClinical systems have their own set of acronyms. While this is not an exhaustive list, in part 1 of our series, we break down the most commonly used acronyms in the general clinical space: what they are, what they represent, and what they mean.
- ADR: adverse drug reaction
Broadly, unwanted, uncomfortable, or dangerous effects that a drug may have.
- AE: adverse event
An unexpected medical problem that arises during treatment with a drug or other therapy. Adverse events may be mild, moderate, or severe, and may be caused by something other than the drug or therapy being given. Also called adverse effect.
- CA: competent authority
Regulatory authorities primarily responsible for the authorization of medicines available in the EU that do not pass though the centralized procedure.
- CDM: clinical data management
The process of collecting, cleaning, and management of subject data in compliance with regulatory standards.
- CDMS: clinical data management system
A system used for the collection, cleaning, and management of clinical subject data.
- CPM: clinical project manager
Plans and manages all aspects of a clinical trial, including managing a team of CRAs and clinical specialists, and acting as a liaison between the study sponsor and the clinical trial site.
- CRA: clinical research associate
A person employed by a sponsor, or by a contract research organization acting on a sponsor's behalf, who monitors the progress, including data entered by a site, source data verification, of investigator sites participating in a clinical study. CRAs are also known as Monitors.
- CRF: case report form
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each subject/patient in a clinical trial.
- CRO: clinical research organization, contract research organization
A company hired by another company or research center to take over certain parts of running a clinical trial. The company may design, manage, or monitor the trial, and analyze the results.
- CSR: clinical study report
An “integrated” full report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in patients.
- DM: data manager (clinical)
Ensures that the right information is collected during a clinical trial and that data is accurate. This is achieved through careful design of the data collection tools and methodology for interrogating the data, and close liaison with the other study management functions.
- DMP: data management plan
A written document that describes the data you expect to acquire or generate during the course of a research project, how you will manage, describe, analyze, and store those data, and what mechanisms you will use at the end of your project to share and preserve your data.
- GCP: good clinical practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies.
- GDPR: general data protection regulation
Ensures that there is one set of data protection rules for all companies operating in the EU, wherever they are based. Stronger rules on data protection mean people have more control over their personal data and businesses benefit from a level playing field. (Link to our blog post on GDPR)
- ICF: informed consent form
The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks, and inconveniences, of alternative therapies available, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.
- ICH: International Conference on Harmonisation
Brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
- IMP: investigational medical product
A pharmaceutical form of an active substance or placebo being tested, or to be tested, or used, or to be used, as a reference in a clinical trial.
- IMPD: investigational medicinal product dossier (EUDRA)
One of several pieces of Investigational Medicinal Product (IMP)-related data required whenever a clinical trial is to be performed in one or more European Union member states. The IMPD includes summaries of information related to the quality, manufacture, and control of any IMP (including reference product and placebo), and data from non-clinical and clinical studies.
- IND: investigational new drug application (US FDA)
The first step in the drug review process of the U.S. Food and Drug Administration (FDA). The company responsible for developing the drug (the sponsor) submits the application to the FDA.
- IRB: institutional review board; independent review board
An appropriately constituted group formally designated to review and monitor biomedical research involving human subjects. This group review serves an important role in the protection of the rights and welfare of human research subjects.
- MAA: marketing authorization application (EUDRA)
A complete dossier of information, including chemical, pharmaceutical, biological, and clinical data, sent to a regulatory authority to support a request for marketing authorization in the European
- MedDRA: Medical Dictionary for Regulatory Activities
Standardized international medical terminology that can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.
- MP: monitoring plan
Establishes the guidelines for conducting monitoring visits and related tasks for monitoring a clinical protocol in accordance with the protocol’s specific requirements.
- NDA: new drug application (US FDA)
The formal final step taken by a drug sponsor: applying to the FDA to get approval required to market a new drug in the U.S.
- PI: principal investigator
The person(s) with primary responsibility for achieving the technical success of the project, while also complying with the financial and administrative policies and regulations associated with the award.
- PRO: patient reported outcomes
Any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.
- QOL: quality of life (questionnaire)
A measure captured during clinical trials as part of patient reported outcomes (PRO). Health-related quality of life (HRQOL) includes the patient’s report of the way a disease or its treatment affects physical, emotional, and social well-being.
- RBM: risk-based monitoring
Directs sponsor oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and trial integrity by appropriate use of centralized monitoring and reliance on technological advances.
- REC: Research ethics committee
Evaluates the ethical acceptability of research before participants can enroll in a study.
- SAE: serious adverse event
Any undesirable experience associated with the use of a medical product in a patient becomes serious and should be reported to the FDA when the patient outcome is death, threatens the life of the patient, requires hospitalization, or is otherwise deemed serious.
- SAP: statistical analysis plan
A detailed elaboration of the principal features of the analysis described in a clinical trial protocol, including procedures for statistical analysis of the primary and secondary variables and other data.
- SDV: source document (data) verification
The process of cross-referencing data recorded in a case-report form to the original source information, an integral part of risk-based monitoring (RBM) strategies.
- SOP: standard operating procedures
Uniformly written procedures, with detailed instructions to record routine operations, processes, and practices followed within a business organization. In clinical research, SOPs help define the standard practices of a group (e.g., unit, division, department, institution, etc.) as well as daily processes conducted to ensure execution of research tasks in accordance with institutional, state, and federal guidelines.
- TMF: trial master file
The collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated – basically the story of how the trial was conducted and managed.
- WHO Drug: World Health Organization drug dictionary
The international reference for medicinal product information. With its unique hierarchical drug-code system and extensive coverage, it provides a consistent drug dictionary with exact terminology when coding concomitant medications.
While there are many more acronyms to decode, this list will aid your understanding and ease your journey as you navigate through the most commonly used general clinical terms.
For our list of eClinical System acronyms, please visit Part Two of our acronym decoding series: Decoding the Alphabet Soup: A Guide to eClinical Systems Acronyms.