The clinical trial industry is filled with acronyms and abbreviations, sometimes differing from organization to organization. In this article, we explore a list of 66 acronyms and abbreviations commonly used in the clinical research space and what each term means.
ADaM: Analysis Data Model
ADaM is one of the required standards for data submission to FDA (US) and PMDA (Japan). Per The Clinical Data Interchange Standards Consortium (CDISC), “ADaM defines dataset and metadata standards that support:
(Learn more via CDSIC: https://www.cdisc.org/standards/foundational/adam)
AE: Adverse Event
Per the FDA’s definition (21 CFR 312.32(a)), an adverse event is “any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.”
An adverse event may be any unfavorable and unintended sign, symptom, or disease.
ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate
The ALCOA acronym was developed by the FDA in the 1990s, and describes basic principles for data integrity. It serves as a framework for data management and documentation practices, and is widely adopted as a best practice within the pharmaceutical industry.
ALCOA defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate.
ANDA: Abbreviated New Drug Application
Per the U.S. Food and Drug Administration (FDA), “an abbreviated new drug application contains data which is submitted to FDA for the review and potential approval of a generic drug product.”
(Learn more via FDA: https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda)
BLA: Therapeutic Biologics Applications
Per the U.S. Food and Drug Administration (FDA), BLAs are a type of application with products including:
(Learn more via FDA: https://www.fda.gov/drugs/types-applications/therapeutic-biologics-applications-bla)
CAPA: Corrective and Preventative Action
Corrective and Preventative Action (CAPA) Plans are documentation used to correct immediate errors in the conduct of research, regardless of error origin (e.g., human oversight, process deficiencies, technology failures).
CAR T: Chimeric Antigen Receptors and T Cells
CAR T-cell therapies are a form of immunotherapy that has generated substantial excitement among researchers and oncologists.
(Learn more via cancer.gov: https://www.cancer.gov/about-cancer/treatment/research/car-t-cells)
CBER: Center for Biologics Evaluation and Research
Per FDA, CBER is the Center within the U.S. Food and Drug Administration that regulates biological products for human use under applicable federal laws. It protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them.
(Learn more via FDA: https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber)
CDASH: Clinical Data Acquisition Standards Harmonization
Per the Clinical Data Interchange Standards Consortium (CDSIC), Clinical Data Acquisition Standards Harmonization (CDASH) “establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.”
(Learn more via CDISC: https://www.cdisc.org/standards/foundational/cdash)
CDER: Center for Drug Evaluation and Research
Per FDA, CDER is the Center within the U.S. Food and Drug Administration that regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work includes medicines as well as things such as fluoride toothpaste, antiperspirants, and sunscreens.
(Learn more via FDA: https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder)
CDISC: The Clinical Data Interchange Standards Consortium
CDISC in an organization that “brings together a community of experts to develop and advance data standards of the highest quality.” CDISC provides Foundational and Therapeutic Area standards, and CDISC Standards are required for regulatory submissions to FDA (U.S.) and PMDA (Japan).
(Visit the CDISC website to learn more: https://www.cdisc.org/)
CDM: Clinical Data Management
Clinical data management (CDM) is used within clinical research to ensure data collected from clinical trials is high-quality, reliable, and statistically sound. Members of CDM teams are actively involved in all stages of a clinical trial, from inception to completion.
CDP: Clinical Development Plan
A strategic, comprehensive clinical development plan (CDP) provides guidance for companies who are developing investigational products. They may help optimize efficiency, control costs, plan timelines, and maximize a program’s probability of success. The creation of an effective CDP requires a consultative, multidisciplinary team of experts.
CFR: Code of Federal Regulations
Per eCRF.gov, the Code of Federal Regulations is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the U.S. Government. Title 21 of the CFR (abbreviated 21 CFR) is reserved for rules of the Food and Drug Administration.
CMC: Chemistry, Manufacturing, Controls
CMC plans outline the significant features of a drug supply and formulation strategy and any placebo or comparator drug supply needs.
CRA: Clinical Research Associate
CRAs, or Clinical Research Associates (sometimes called clinical monitors or trial monitors) are life science professionals who oversee clinical trials on behalf of a Sponsor.
CRC: Clinical Research Coordinator
Clinical Research Coordinators manage the day-to-day clinical trial activities at a clinical trial site. CRCs work with an under the direction of a Principal Investigator.
CRF: Case Report Form
Case Report Forms are electronic (“eCRF”) or paper documents used in a clinical trial to record the protocol and required information about each trial participant. It is the main tool that Investigators use to collect information from clinical trial participants, and should be completed soon after each participants initial visit to ensure that information can be follow up on while the participant is easily accessible.
CRO: Contract Research Organization, sometimes also defined as Clinical Research Organization
A CRO is a company that provides support to pharmaceutical, biotechnology, and medical device companies that are developing new medicines and drugs. Many CROs specifically provide clinical trial services, which may include services like clinical operations, data management, biostatistics, and medical writing.
PharPoint Research is one example of a U.S.-based contract research organization.
CRT: Case Report Tabulation
The Case Report Tabulation (CRT) is the collection of annotated case report form (CRF), SAS datasets, metadata, and source programs that comprise a portion of the NDA package submitted to the FDA.
CSR: Clinical Study Report
A Clinical Study Report (CSR) is a document describing the methods and results of a clinical trial. It requires the input, review, and approval of a cross-functional team. Much of a CSR draft is typically written by a medical writer.
CTA: Clinical Trial Agreement
A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between a study Sponsor and clinical trial sites. CTAs include information such as an acknowledgement of responsibilities, payment, and intellectual property terms.
CTCAE: Common Terminology Criteria for Adverse Events
The Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be used for Adverse Event reporting. It is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials, and other oncology settings.
(Learn more via the NIH’s National Cancer Institute: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm)
CTMS: Clinical Trial Management System
A clinical trial management system (CTMS) is a specialized project management software system used to manage and track clinical research activities from study startup to closeout. It is used as a hub for research operations, simplifying study conduct and improving visibility.
DBL: Database Lock
Database lock is a pivotal milestone within a clinical trial signifying the end of data collection and the point at which no more changes can be made to the clinical database. Following database lock, the statistical analysis and reporting can occur.
DCT: Decentralized Clinical Trial
Decentralized clinical trials, or DCTs, are clinical trials where some or all trial-related activities take place at locations remote from the investigator, utilizing telemedicine, mobile/local healthcare providers, and/or mobile technologies.
DMC: Data Monitoring Committee
DMCs are an independent group of experts who monitor patient safety and may also monitor treatment efficacy data while a clinical trial is ongoing.
A DMC may also be known as an Independent Data Monitoring Committee (IDMC) or Data and Safety Monitoring Board (DSMB).
DSMB: Data and Safety Monitoring Board
See “DMC”
DSUR: Development Safety Update Report
DSURs are intended to provide a comprehensive annual review of safety information. The main objective of a DSUR is to present a comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by: (1) examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the investigational drug’s safety; (2) describing new safety issues that could have an impact on the protection of clinical trial subjects; (3) summarizing the current understanding and management of identified and risks; and (4) providing an update on the status of the clinical investigation/development program and study results.
eCOA: Electronic Clinical Outcome Assessment
eCOA is a measure that is collected electronically and describes or reflects how apatient feels, functions, or survives. Per FDA, types of clinical outcome asssessments include:
EDC: Electronic Data Capture
EDC, or Electronic Data Capture, is a system used to store patient data collected in clinical trials.
ePRO: Electronic Patient-Reported Outcomes:
Patient reported outcomes are a type of clinical outcome assessment (see “eCOA”). ePROs specifically are electronically-collected measurements that come directly from a patient about the status of a patient’s health condition. Examples of PRO measures include rating scales and counts of events.
eTMF: Electronic Trial Master File
An eTMF is a technology solution that organizes, gathers, stores, monitors and archives necessary study documents. In the past, this file existed in physical paper form (“TMF”), but today is typically digital.
FDA: Food and Drug Administration
The United States FDA is a federal organization that is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biologics, medical devices, and other products.
FIH: First in Human
Per the NIH, an FIH study is “a type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time.” FIH studies are typically done as Phase 1 clinical trials.
FPI: First Patient In
FPI refers to the actual date on which the first participant was enrolled in a clinical study.
GCP: Good Clinical Practice
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.
GDP: Good Documentation Practice
Good Documentation Practices are guidelines that set standards for how documents are created, maintained, and stored. These practices help ensure the quality and integrity of data collected in research.
IB: Investigators Brochure
Investigators Brochures are comprehensive documents summarizing information about an investigational drug. The IB is updated as a program progresses and new information becomes available, and is expected to include information like:
ICF: Informed Consent Form
Per FDA, “informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment.” The ICF is the form signed by a subject to acknowledge consent.
ICH: International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
ICH is an organization formed in 1990 to achieve greater harmonization worldwide to ensure safe, effective, and high quality medicines are developed, registered, and maintained in the most resource efficient manner whilst meeting high standards. This is accomplished through the development of technical guidelines that are implemented by multiple regulatory agencies. As of November 2024, there are 23 members of ICH, including the United States FDA.
IMV: Interim Monitoring Visit
IMV is a type of monitoring visit conducted during the “maintenance” phase of a trial. The purpose of these visits is to monitor the study progress and conduct, ensure subject safety, review and verify the site’s data, and ensure investigational product/device is adequate and maintained throughout the lifecycle of the study.
IND: Investigational New Drug Application
The IND is a request for authorization from the FDA to administer an investigational drug or biological product to humans. There are three different IND types (Investigator IND, Emergency Use IND, and Treatment IND) and two different IND categories (Commerical and Research).
(For more information on INDs, see the FDA website.)
IP: Investigational Product
IP refers to a vaccine, drug, biologic, devices, diagnostic, or palliative used in a clinical trial.
IRB: Institutional Review Board
Per FDA, “an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects.” IRBs are focused on ensuring studies take the appropriate steps to protect the rights and welfare of subjects, and review research protocols and related materials to ensure that protection.
(See frequently asked questions regarding IRBs on the FDA website.)
IRT: Interactive Response Technology
IRT is an umbrella term that includes both Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS). These technologies are used to randomize patients into a clinical trial and track drug supply.
LPLV: Last Patient, Last Visit
Last Patient, Last Visit is a critical milestone within a trial referring to the date at which the last participant completes their final visit within a clinical trial. Following this visit, final data cleaning and database lock can occur.
MAD: Multiple Ascending Dose
MAD studies are used to assess drug dosing for new therapeutics. In these studies, patients will receive multiple doses over a study period. Each time they receive the drug, the dose increases. MAD studies typically occur after SAD studies conclude and build on knowledge from the SAD study. However, MAD studies can still be a part of a Phase I trial.
(See also: SAD (Single Ascending Dose))
MedDRA: Medical Dictionary for Regulatory Activities
MedDRA is a “rich and highly specific standardized medical terminology” developed in the late 1990s by the ICH.
NDA: New Drug Application
The NDA application allows drug sponsors to formally propose that the FDA approve a new pharmaceutical of sale and marketing in the United Sates. Robust documentation is included within an NDA.
(See FDA website for resources on NDA submissions)
NME: New Molecular Entity
The FDA classifies certain drugs as NMEs for purposes of FDA review. Per FDA, “many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients.”
PI: Principal Investigator
The PI refers to the person who prepares and carries out the clinical trial protocol, leading the clinical research team and monitoring study participants’ health to determine the study’s safety and effectiveness. A PI is typically a doctor or other medical professional.
PSUR: Periodic Safety Update Report
PSURs are pharmacovigilance documents that present a comprehensive assessment of the worldwide safety data of a marketed drug or biological product.
RCT: Randomized Controlled Trials
RCTs are the gold-standard for studying the effectiveness of a new intervention or treatment.
RECIST: Response Evaluation Criteria in Solid Tumors
According to the NCI’s Dictionary of Cancer Terms, RECIST is “a standard way to measure how well a cancer patient responds to treatment.”
SAD: Single Ascending Dose
SAD studies are used to assess drug dosing for new therapeutics. In these studies, patients receive one dose of a drug. Different groups of participants will receive different dose of the experimental treatment, allowing the sponsor to gather information regarding the safe dose range. SAD studies are typically the first in human (FIH) study.
(See also: MAD (Multiple Ascending Dose))
SAE: Serious Adverse Event
Per FDA, an adverse event (“AE”) is “any undesirable experience associated with the use of a medical product in a patient.” An event is considered serious and should be reported to the FDA if the patient outcome is:
SAP: Statistical Analysis Plan
The SAP is a document that outlines planned statistical methods and procedures that will be used to interpret data collected during a clinical trial.
SDR: Source Document Review
SDR is the process of reviewing source documentation to check the quality of the source. SDR is a “zoomed out” view that looks at pieces of data holistically, used to review protocol compliance and ensure pritical processes and source documentation is sufficient.
SDTM: Study Data Tabulation Model
Per CDISC, “SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.” SDTM is a required standard for data submission to FDA.
SDV: Source Data Verification
SDV is the process by which data within the case report form (CRF) or other data collection system are compared to the original source of information to confirm the data was transcribed accurately. SDV is used to generate queries within the EDC system, ensuring source data is aligned with data entered.
SIV: Site Initiation Visit
The SIV is a type of monitoring visit intended to prepare and train a site to conduct a clinical trial.
SQV: Site Qualification Visit
The SQV is a type of monitoring visit specifically intended to assess a site’s qualifications, capabilities, interests, and potential to conduct a clinical trial of interest.
TLF: Tables, Listings, and Figures
Tables, listings, and figures are what are used when writing the Clinical Study Report (CSR), publishing results on ClinicalTrials.Gov, and developing the package insert for approved products.
TPP: Target Product Profile
The TPP defines the key characteristics of a marketed drug product. It typically includes information such as:
UAT: User Acceptance Testing
User Acceptance Testing is a phase of software development in which the software is tested in the “real world.” At PharPoint, UAT is performed during the database build process – either by the PharPoint team or a sponsor – to ensure a clinical database is functioning as expected.
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