Resources

Clinical Research Glossary

Acronyms and working definitions for clinical trials, FDA regulatory affairs, quality systems, and clinical operations.

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1572: FDA Form 1572, statement of investigator. An agreement signed by the investigator to provide information to the sponsor and commit to comply with FDA regulations for investigational drugs and biologics.

A

acceptance criteria: Conditions under which deliverables and milestones are considered complete.
AccessGUDID: FDA public interface to the Global Unique Device Identification Database, commonly used to verify UDI-related device information.
action-decision-issue (ADI) log: A governance record that captures actions, decisions, and open issues with owners, due dates, and closure evidence. See also: issue log; decision trail.
active pharmaceutical ingredient (API): The active component intended to furnish pharmacological activity or other direct effect.
ADaM: Analysis Data Model, a CDISC standard for analysis datasets.
adverse event (AE): Any untoward medical occurrence in a subject administered a product, whether or not causally related.
adverse reaction (ADR): An adverse event for which there is a reasonable possibility of a causal relationship to the product. See also: suspected adverse reaction.
AI: Artificial intelligence.
ALCOA+: A data integrity lens used across regulated work to evaluate whether records are trustworthy: attributable, legible, contemporaneous, original, accurate, plus complete, enduring, and available.
audit: A systematic, independent examination, often sponsor-led or delegate-led, to determine whether trial-related activities and data comply with protocols, SOPs, GCP, and applicable requirements. See also: inspection.
audit trail: A secure, time-stamped record, often computer-generated, that allows reconstruction of who did what and when within a system. In this glossary, audit trail is treated as both a system control and evidence of defensible execution.

B

BA: Bioavailability.
BE: Bioequivalence.
Biologics License Application (BLA): The marketing application type for many biologics regulated under the PHS Act and FD&C Act authorities.
Bioresearch Monitoring (BIMO): FDA program activities focused on monitoring the conduct of FDA-regulated research and ensuring data integrity and human subject protection.
blinding: Keeping one or more parties unaware of treatment assignments, such as single-blind or double-blind designs.

C

CAPA: A structured approach to investigate issues, address root causes, implement corrective actions, and prevent recurrence through preventive actions and effectiveness checks.
CBER: FDA Center for Biologics Evaluation and Research.
CCB: Change control board.
CDER: FDA Center for Drug Evaluation and Research.
CDISC: Clinical Data Interchange Standards Consortium.
CDRH: FDA Center for Devices and Radiological Health.
CFR: Code of Federal Regulations.
CFSAN: FDA Center for Food Safety and Applied Nutrition.
CGTP: Current Good Tissue Practice.
change control: A controlled process to evaluate, approve, implement, and document changes that may affect compliance, product quality, subject safety, or data integrity.
clinical hold: A regulatory action that delays or suspends a clinical investigation. Context and mechanics differ across products and frameworks. Operationally, it triggers immediate governance, communication control, and remediation.
clinical quality assurance (CQA): Quality oversight focused on clinical trial conduct, vendor oversight, inspection readiness, and compliance evidence.
clinical study report (CSR): The integrated report of study methods and results, typically aligned to ICH expectations. It is key inspection-era evidence because it ties protocol intent to analysis and outcomes.
CMC: Chemistry, Manufacturing, and Controls.
Code of Federal Regulations (CFR): The codified set of general and permanent rules published in the Federal Register by federal departments and agencies. For this glossary, 21 CFR is the primary FDA regulatory anchor.
combination product: A product comprised of two or more regulated components, such as a drug, device, or biologic, combined into a single entity or used together. Combination products drive cross-framework compliance and primary mode of action determination.
complaint (devices): Any communication alleging deficiencies related to identity, quality, durability, reliability, safety, effectiveness, or performance of a device after release for distribution. See also: MDR; CAPA.
COC: Chain of custody.
COI: Conflict of interest.
CRA: Clinical research associate, or study monitor. A sponsor or CRO representative who monitors sites to verify subject protection, protocol compliance, and data quality.
CRC: Clinical research coordinator. Site-based staff who coordinates day-to-day trial activities, such as scheduling, subject visits, documentation, and data entry, under PI oversight.
CRFs: Case report forms used to collect protocol-required data in the trial database.
CRO: Contract research organization. An organization contracted by the sponsor to perform one or more trial-related duties, such as monitoring or data management. The sponsor retains ultimate responsibility for data quality and integrity.
critical path: The sequence of tasks that determines the minimum project duration. Delays on this path delay the overall timeline.
CSR: Clinical study report. An integrated written report of an individual study, combining clinical and statistical descriptions and analyses, typically structured per ICH E3.
CTD: Common Technical Document.
CTMS: Clinical Trial Management System.
CTQ: Critical to quality.

D

dashboard: A structured presentation of selected measures and narrative interpretation that summarizes current status against plan and highlights emerging risk.
Data Monitoring Committee (DMC) / DSMB: An independent committee that reviews accumulating data to protect subject safety and maintain study integrity.
data transfer specification (DTS): A controlled description of how data move between systems, including mapping, schedules, checks, and exception handling.
DBL: Database lock. The point when the clinical database is finalized, queries are resolved, data are cleaned, and the database is locked before analysis.
De Novo (devices): A premarket pathway to classify novel, low-to-moderate risk devices for which there is no legally marketed predicate.
deviation: A departure from a planned process, procedure, or expectation. Use qualifiers consistently, such as protocol deviation, process deviation, or quality system deviation, to prevent drift.

E

electronic Code of Federal Regulations (eCFR): The continuously updated online version of the CFR, used to check current text and scope definitions.
electronic records and signatures (21 CFR Part 11): FDA requirements for electronic records and electronic signatures, emphasizing controls such as access, audit trails, integrity, and validation.
EMA: European Medicines Agency.
endpoint: Predefined outcome measure used to assess treatment effect.
enforcement action: Regulatory actions taken in response to compliance concerns, ranging from correspondence, such as warning letters, to legal actions, such as injunction or seizure, depending on severity and posture.
Establishment Inspection Report (EIR): FDA report that documents inspectional findings and context. It is a key record in interpreting inspection outcomes.
ESG: Electronic Submissions Gateway, FDA submission transport.
EU: European Union.
EUA: Emergency Use Authorization.
EHR: Electronic health record.

F

FAERS: FDA Adverse Event Reporting System.
FDA: The United States Food and Drug Administration.
FDF: Financial disclosure form, FDA Forms 3454 and 3455. Financial certification or disclosure required for covered studies, typically documented using FDA Form 3454 for certification and/or FDA Form 3455 for disclosure.
FIH: First in human.
First patient in (FPI) / first participant first visit (FPFV): Operational milestones marking the start of enrolled participant activity. Standardize terms within a study or team to reduce ambiguity.
Form FDA 483: Written list of inspectional observations issued at the conclusion of an inspection when conditions may constitute violations. See also: EIR; CAPA; 483 response.
Freedom of Information Act (FOIA): U.S. law enabling public access to federal agency records with defined exemptions. It is relevant to public-facing inspection and enforcement materials.

G

GDPR: General Data Protection Regulation.
Good Clinical Practice (GCP): Quality standard for designing, conducting, recording, and reporting trials to protect participants and ensure credible data.
Good Guidance Practices (GGP): FDA practices governing how guidance documents are developed and issued. Guidance reflects current thinking but is generally nonbinding.
Good Laboratory Practice (GLP): Requirements for nonclinical laboratory studies, emphasizing study conduct, documentation, and data integrity.
Good Manufacturing Practice (GMP / cGMP): Enforceable expectations for manufacturing controls, quality, and documentation. Use cGMP when referring to FDA current expectations.
Guidance: FDA nonbinding statements describing current thinking, recommendations, and approaches. Guidance does not create legally enforceable rights or responsibilities, but it is high-signal for expectations.

H

HIPAA: Health Insurance Portability and Accountability Act.

I

IB: Investigator's brochure.
ICF: Informed consent form. Written, signed, and dated document used to record a participant's informed consent.
ICH: International Council for Harmonisation. An international body that develops harmonized technical guidelines, such as ICH E6 GCP, used across regions.
ICMRA: International Coalition of Medicines Regulatory Authorities.
IDE: Investigational device exemption. Allows an investigational device to be used in a clinical study to collect safety and effectiveness data.
IMDRF: International Medical Device Regulators Forum.
IMV: Interim monitoring visit.
IND: Investigational new drug application. FDA submission requesting authorization to administer an investigational drug or biologic to humans.
informed consent: The process of providing information and obtaining voluntary agreement to participate. The informed consent form is evidence of the process, not the process itself.
inspection: A regulator-led assessment of compliance, such as by FDA or another authority. Distinguish from sponsor audits.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC): Committee responsible for review and continuing oversight of research involving human subjects to ensure ethical conduct and subject protection.
Investigational device exemption (IDE): Framework allowing shipment of an investigational device for clinical study. See also: SR/NSR.
Investigational New Drug (IND): Application to FDA to begin clinical investigation of a drug or biologic product. It includes sponsor responsibilities and safety reporting expectations.
Investigator brochure (IB): Investigator's brochure. Compilation of clinical and nonclinical information on the investigational product relevant to study in humans. It supports investigator understanding and risk communication.
IP/IMP: Investigational product or investigational medicinal product. The investigational drug or biologic, or placebo/comparator, being tested or used as a reference in a trial. IMP is commonly used in many non-U.S. contexts.
IRB/IEC: Institutional review board / independent ethics committee. An independent body that reviews a trial to protect the rights, safety, and well-being of participants.
ISF: Investigator site file.
issue log: A controlled record of issues, owners, due dates, impact, and closure evidence. It is distinct from a risk register.

L

labeling: Regulated information that accompanies a product. Scope and controls differ across drugs, biologics, and devices. See also: IFU; SPL; PLR.

M

MAUDE: Manufacturer and User Facility Device Experience, FDA device adverse event database.
MDUFA: Medical Device User Fee Amendments.
MedDRA: Medical Dictionary for Regulatory Activities. Internationally used medical terminology for coding and grouping adverse events and other medical concepts for reporting and analysis.
MedWatch: FDA safety information and adverse event reporting program, including forms and routing for reporting.
metric: A quantitative measure of a project, process, deliverable, or outcome.
MHRA: The United Kingdom Medicines and Healthcare products Regulatory Agency.
MLR: Medical-legal-regulatory review.
MRCT: MRCT Center, Multi-Regional Clinical Trials Center.

N

NAI: No action indicated, inspection outcome classification.
NCTR: National Center for Toxicological Research.
NDA: New Drug Application.
NSR: Non-significant risk, device study classification.

O

OAI: Official action indicated, inspection outcome classification.
OCP: Office of Combination Products.
ORA: FDA Office of Regulatory Affairs.
OTC: Over-the-counter.

P

PDUFA: Prescription Drug User Fee Act.
PI: Principal Investigator. Responsible leader of the trial team at a site and accountable for conduct of the clinical trial at that site.
placebo: Inactive product that looks like the investigational treatment but has no active ingredients. Used as a comparator.
PMA: Premarket approval, device application type.
PMDA: Japan Pharmaceuticals and Medical Devices Agency.
PMC: Postmarketing commitment.
PMR: Postmarketing requirement.
Postmarketing commitment (PMC) vs postmarketing requirement (PMR): PMRs are required, typically by statute, regulation, or authority. PMCs are agreed upon but not legally required in the same way. Treat the distinction as inspection-relevant.
Premarket approval (PMA): High-risk device marketing application pathway requiring FDA approval.
protocol: Document describing the objectives, design, methodology, statistical considerations, and organization of a clinical trial.
protocol amendment: Written changes to or formal clarification of a protocol.
PV: Pharmacovigilance.

Q

QA: Quality assurance.
QbD: Quality by design.
QC: Quality control.
QMS: Quality management system.
QMSR: Quality Management System Regulation, device quality regulation evolution.
QSR: Quality System Regulation, devices.
QTL: Quality tolerance limit.
Quality management system (QMS): The organizational system used to direct and control quality-related activities. It includes governance, documentation, training, CAPA, and management review.

R

RAC: Regulatory Affairs Certification, a RAPS credential.
randomization: Assigning participants to treatment or control groups using chance to reduce bias.
RBQM: Risk-based quality management.
recall: A firm's removal or correction of a marketed product that is in violation of laws administered by FDA. Distinguish from device corrections and removals under the device framework.
Risk-based quality management (RBQM): Systematic, risk-based approach to planning and executing oversight to focus attention on what matters most for subject protection and data reliability.
root cause analysis: Structured analysis to identify underlying causes of a problem. Quality expectation is not just a cause, but a defensible cause supported by evidence.
RWE: Real-world evidence.

S

SAE: Serious adverse event.
safety signal: Information suggesting a new potentially causal association or a new aspect of a known association between a product and an event. It requires evaluation and disposition.
Serious adverse event (SAE): An AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
SME: Subject matter expert.
SOP: Standard operating procedure. Detailed written instructions to achieve uniformity in performing a specific function.
source data / source documents: Original records and certified copies needed to reconstruct and evaluate the trial, such as medical records, lab printouts, and device outputs.
sponsor: Individual, company, institution, or organization responsible for initiation, management, and/or financing of a clinical trial.
SPL: Structured Product Labeling.
SR: Significant risk, device study classification.
stakeholder: Person or function with interest in, influence over, or impact from the work. Define stakeholder roles explicitly when governance is high friction.
standard operating procedure (SOP): Controlled instructions describing how work is to be performed. Changes require document control and training evidence.
statute: A law enacted by a legislative body. In FDA work, statutes are the legal foundation that authorizes FDA regulation and enforcement.
Sub-I: Sub-investigator. Member of the clinical trial team designated and supervised by the investigator to perform critical trial-related procedures and/or make important trial-related decisions.
SUSAR: Suspected unexpected serious adverse reaction. A serious adverse reaction whose nature, severity, or outcome is unexpected based on reference safety information and subject to expedited reporting.
Suspected adverse reaction: An adverse event for which there is a reasonable possibility of causal relationship to the product. Used in contexts where suspected causality matters operationally.

T

Trial master file (TMF): The set of essential documents that permits evaluation of trial conduct and data quality. It is an inspection-relevant evidence system, not a filing exercise.

U

USC: United States Code.

V

VAI: Voluntary action indicated, inspection outcome classification.
validation: Documented evidence that a process, method, or system performs as intended and meets requirements. In computerized systems, validation supports integrity and reliability of electronic records.
vendor: External party providing services. Define delegated responsibilities explicitly because delegation does not remove sponsor accountability.

W

warning letter: FDA correspondence describing significant violations and requesting corrective action. It is high-signal for enforcement and inspection trend monitoring.
WHO: World Health Organization.