Glossary of Terms Used in Regulatory Science

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100% Source Data Verification: Sponsors and monitors have traditionally relied on 100% of source data verification as the primary method of ensuring data quality during on-site monitoring.

Adverse Events (AE): Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (International Council for Harmonisation Good Clinical Practice Addendum) 

ALOCA+CCEA: An acronym for nine data attributes that adhere to good documentation practices and Good Clinical Practice: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. 

Audit: A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirement(s) (International Council for Harmonisation  Good Clinical Practice Addendum). 

Auditors: Individuals who are responsible for ensuring that data quality is maintained and that all clinical trial processes are adequate and appropriate. 

Blinding/Masking: A procedure in which one or more parties in the trial are kept unaware of the treatment assignment(s) is called blinding. Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor(s), and, in some cases, data analyst(s) being unaware of the treatment assignment(s). 

Case Series: The simplest form of observational studies is case series. It follows the clinical course of a particular condition in a group of individuals. 

Case-Control Studies: The studies which compare patients who have a disease or outcome of interest (cases) with patients who do not have the disease or outcome (controls), and look back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the disease. 

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Case Report Forms (CRFs): A printed, optical, or electronic document designed to record all protocol required information to be reported to the sponsor on each trial subject. (International Council for Harmonisation Good Clinical Practice Addendum) 

Central Monitoring: In central monitoring, the sponsor or CRO reviews the information that has been electronically submitted by the site. Central monitoring is not usually conducted by the designated Clinical Research Associate for the site but instead performed off-site by a central monitor. 

Clinical Research Coordinator/Research Coordinator (CRC): An individual who assists in managing day-to-day trial activities. While effective team operations are ultimately the responsibility of the Principal Investigator, a clinical research coordinator is integral in developing and maintaining a highly functioning clinical research team. The responsibilities of a CRC may include recruiting potential trial participants, screening recruits, and obtaining consent from participants to join the clinical trial. Additionally, CRCs commonly handle samples and specimens, record and/or enter data into appropriate forms and resolve any data discrepancies. They often take the lead in preparing for monitoring and auditing visits. Due to these responsibilities, CRCs are typically the first line of defense in ensuring data quality in a clinical trial and should develop processes to maintain quality throughout day-to-day activities. In the industry-sponsored trials, CRCs often serve as the primary point of contact for the site and must effectively relay information between the site and the sponsor.

Clinical Studies/Clinical Investigations: General terms for clinical research. 

Clinical Trial: Any investigation in human participants intended to discover or verify the clinical, pharmacological, and/or pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

The Food and Drug Administration defines clinical trials as human participant research involving investigational products like drugs, biologics, or devices.

The National Institute of Health defines clinical trials more broadly to include not only investigational products but also other interventions like surgical procedures, diagnostic strategies, diet, exercise, and cognitive therapy.

Clinical Trial Documentation: International Council for Harmonisation Good Clinical Practice Addendum states that clinical trial documentation includes all written and electronic documents used in a clinical trial such as approval from an institutional review board, details regarding clinical trial conduct, and final reports and records. 

Code and Federal Regulations (CFR): General and permanent rules and regulations published in the Federal Register by the executive departments and agencies of the federal government. 

Cohort Studies: In these studies, the presence of specific exposures is ascertained within a group of individuals who are free of the outcome of interest, and incident events are evaluated from that point forward. 

Concomitant Medications: Prescription medications, over-the-counter drugs, dietary supplements, or biological products taken by a study participant in addition to the drug under investigation during a clinical trial are considered concomitant medications.

Confidentiality: Prevention of disclosure of a sponsor’s proprietary information or a participant’s identity to anyone other than authorized individuals.

Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. 

Corrective and Preventive Action Plan (CAPA): The purpose of a Corrective and Preventive Action Plan is to identify an issue, discover the root cause of the issue, find a solution to prevent recurrences of the issue, implement the solution, and ensure the solution is successful. The Food and Drug Administration expects Corrective and Preventive Action Plans to be integrated into the quality control function of a clinical trial.  

COVID-19: A disease caused by SARS-CoV-2 that can trigger a respiratory tract infection.  

Cross-Sectional Studies: Studies in which exposures and outcomes are ascertained simultaneously. 

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Data and Safety Monitoring Committee (DSMC): An independent body established by the sponsor to review data from an ongoing clinical trial. The Data and Safety Monitoring Committee advises the sponsor regarding the safety of trial participants as well as the validity and scientific merit of the trial. Members are typically specialists who can assess the safety and efficacy of results and make recommendations to continue, modify, or stop a trial. Unlike clinical trial monitors, the members of a Data and Safety Monitoring Committee do not oversee quality control of clinical trial site(s). Data and Safety Monitoring Committees are also known as Data Monitoring Committees.

Database Studies: Studies involving the analysis of the relationship between exposures and outcomes based on patient data from a registry. 

Early Feasibility Studies: Studies that are conducted in a few patients early in the process, before the device design is finalized. These studies are exploratory in nature and provide proof of concept as well as insights into the potential clinical use and performance of the device. Early feasibility studies are not required by the FDA for device approvals. 

Electronic Case Report Forms (eCRF): An auditable electronic record designed to capture information required by the clinical trial protocol to be reported to the sponsor on each trial participant.

Electronic Investigator Site File (eISF): Digital storing of investigative site binder is a seamless process to conduct remote monitoring.  

Electronic Patient Reported Outcome (ePRO): The term patient-reported outcomes (PROs) refer to a health outcome solely based on patient self-reporting. Many clinical research settings are transitioning away from pen-and-paper data collection methods and moving to electronic patient-reported outcomes (ePROs).

Electronic Trial Master File (eTMF): The all-important trial master file in a digital format.  

Essential Documents: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (International Council for Harmonisation Good Clinical Practice Addendum) 

FDA: United States Food and Drug Administration.  

Feasibility Studies: These studies, while exploratory and larger than early feasibility studies, aim to support future pivotal studies or to answer basic research questions. Typically conducted in fewer than 30 patients, they are required by the FDA to demonstrate initial proof of safety and feasibility.

Form FDA 1572: A Food and Drug Administration form known as the Statement of Investigator, is a contract that clinical trial investigators must sign to participate in clinical trials involving investigational drugs or biologics.

Form FDA 3455: A Food and Drug Administration form known as the Statement of Investigator, is a contract that clinical trial investigators must sign to participate in clinical trials involving investigational drugs or biologics

Genome-Wide Association: Studies that are conducted by identifying genes involved in human disease which gives rise to the possibility of analyzing a person’s risk of developing a certain disease. These studies specifically search the genome for small variations, called single nucleotide polymorphisms.

Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, 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 participants are protected.

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High Risk Data Points: Data points which are prone to mistakes or difference in interpretation or transcription and which have a high impact on data quality and the study outcome. 

HIPAA: An abbreviation for Health Insurance Portability and Accountability Act of 1966, which assures that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care. 

Impartial Reporting: Truthful and accurate reporting of audit activities. 

Independent Ethics Committee (IEC): An independent body, such as a review board or committee (which can be institutional, regional, national, or supranational), consisting of both medical professionals and non-medical members, is responsible for ensuring the protection of the rights, safety and well-being of human participants involved in a trial. This body provides public assurance of that protection by, among other tasks, reviewing and approving or providing favorable opinions on the trial protocol, the suitability of the investigator(s), the facilities, and the methods and materials used in obtaining and documenting informed consent from trial participants. The legal status, composition, function, operations, and regulatory requirements of Independent Ethics Committees may vary among countries but should allow the committee to operate in compliance with GCP as described in this guideline. (International Council for Harmonisation Good Clinical Practice Addendum).

Industry-Sponsored Trials/Industry-Initiated Trials: Trial designed and overseen by an organization that develops the investigational plan, selects sites and investigators, and manages the legal, regulatory, and financial aspects of the clinical trial. A sponsor may delegate certain responsibilities to other parties; however, it remains ultimately accountable for ensuring delegated tasks are properly conducted. For example, a sponsor must ensure proper monitoring of a clinical trial, even if a clinical research organization conducts monitoring visits.

Informed Consent Form (ICF): Form obtained before a participant can join the trial that provides documentation of their consent.

Inspection: The act, by a regulatory authority or authorities, of conducting an official review of documents, facilities, records, and any other resources that are deemed related to the clinical trial. These resources may be located at the trial site, at the sponsor’s and/or contract research organization’s facilities, or at other establishments deemed appropriate by the regulatory authority or authorities.

Institutional Review Board (IRB): An independent body composed of medical, scientific, and non-scientific members, whose responsibility is to ensure protection of the rights, safety and well-being of human participants involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments, as well as the methods and material used in obtaining and documenting informed consent from the trial participants. In this context, an IRB is considered equivalent to an Independent Ethics Committee. (International Council for Harmonisation Good Clinical Practice Addendum).

Intercurrent Illness: Disease or disorder occurring during the process of clinical trial of another disorder.

Interim Report: A report of interim results and their evaluation based on analyses conducted during the course of a trial.

Interim Visit: Any visit from the study sponsor or monitor that occurs after the site is initiated up until the site is closed out. The objective of an interim visit is to assess the progress of the trial/study in terms of accuracy, completeness and verification of reported trial data. 

International Council for Harmonisation (ICH): A harmonization project involving regulatory authorities and the pharmaceutical industry started in 1990 with the objective of improving efficiency of new drug development and registration process, promoting public health, preventing duplication of clinical trials in humans, and minimizing the use of animal testing without compromising safety and effectiveness. These goals that are achieved through the development and implementation of harmonized guidelines and standards such as GCP. (International Council for Harmonisation, U.S. Food and Drug Administration and Health Canada Regional Public Consultation).

Investigational Product: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (International Council for Harmonisation Good Clinical Practice Addendum).

Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial involves a team, this individual leads the team and may be referred to as the Principal Investigator or Clinical Investigator. (International Council for Harmonisation Good Clinical Practice Addendum).

Investigator-Initiated Trials: Trials initiated and overseen by a Principal Investigator who is sometimes referred to as a sponsor-investigator. 

Investigator’s Brochure: A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human participants.

Limited Prospective Exception/Protocol Exception: An instance where a sponsor and investigator agree to enroll a single participant who does not meet all inclusion criteria.

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Master Randomization List: Documentation of the method used to assign individuals to clinical trials. 

Monitoring: The act of overseeing the progress of a clinical trial to ensure that it is conducted, recorded, and reported in accordance with the protocol Standard Operating Procedure, Good Clinical Practice, and applicable regulatory requirement(s) is called monitoring. (International Council for Harmonisation Good Clinical Practice Addendum) 

Monitoring Plan: An outline that provides guidance for the conduct of monitoring visits is considered a monitoring plan. The plan includes who will be the monitor, the duration and frequency, type of monitoring, and the documents, equipment, personnel, and other items that will be monitored. 

Monitoring Report: A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s Standard Operating Procedure(s) is a monitoring report. (International Council for Harmonisation Good Clinical Practice Addendum) 

Monitors: Individuals who are responsible for ensuring that all regulatory requirements are met and for checking data on case report forms prepared by trial site staff, verifying the data against source documents.

Natural History: A type of medical research study during which researchers examine how a disease develops over time. Researchers follow participants who are at risk for or have a specific disease or condition to determine how specific factors, such as family history, age, and occupational exposure, affect the development or progression of the disease or condition. Data collected during a natural history also provide information on how best to treat a condition or disease.  

National Institute of Health (NIH): Is the primary Federal agency for conducting and supporting medical research.

Non-Compliance: Failure or refusal to adhere to a law, regulation, or term of a contract.

Non-Conformity: Failure to meet established standards and certifications. It is a general term that encompasses instances where a product, service, or process fails to meet the specified requirements.

Observational Studies: Studies that do not have an intervention and patients are allocated treatment based on clinical decision. 

On-Site Monitoring: Monitoring that occurs on-site or in-house. For industry-sponsored trials, this type of monitoring is usually conducted before, during, and after trial completion. It is performed by a monitor or Clinical Research Associate. A sponsor may provide the Clinical Research Associate or outsource the function to a Clinical Research Organization. In either case, the monitoring function for industry-sponsored trials is performed by someone outside of the trial site organization, providing objective oversight of the trial. In this case, the monitor would be considered an external affiliate of the trial site. 

Other Unplanned Protocol Noncompliance: Any unplanned instance of protocol noncompliance. Multiple deviations of this type may lead to serious consequences. For example, if an investigator fails to perform tests as required by the protocol.

Patient Binder: Trial participant record with dosage of product, adverse effects or benefits and protocol deviations, if any. 

Pharmacodynamic (PD) Effects: The study of a drug’s molecular, biochemical, and physiologic affects or actions in an organism.

Pharmacokinetics (PK): The study of how the organism interacts with administered substances for the entire duration of exposure.

Phase I Clinical Trials: Known as first-in-human studies, Phase 1 trials aim to elucidate the initial effects of the investigational product on human physiology. During this phase, the primary focus is given to assessing the safety and tolerability of the product. These trials collect the most prevalent and serious adverse events to establish the product’s initial safety and tolerability profile. Additionally, biological specimens are collected to understand the product’s metabolic and excretory pathways. Phase I trials involve the participation of 20 to 100 healthy volunteers.

Phase II Clinical Trials: Known as exploratory or proof-of-concept studies, Phase II trials are designed to gather evidence of a product’s effectiveness in a specific indication. Unlike Phase I trials, Phase II trials are larger in scale and involve several hundred patients diagnosed with the specific disease or condition under investigation. In addition to collecting efficacy data, Phase II trials also aim to identify common short-term side effects and risks associated with the investigational product.

Phase I/II Clinical Trials: Name termed with the phase I clinical trials that cannot be ethically conducted in a healthy population. For instance, administering a toxic drug such as an anticancer medication to a healthy volunteer would be inappropriate.

Phase III Clinical Trials: Phase III clinical trials are conducted to confirm the efficacy and safety observed in Phase I and II trials. Often termed as confirmatory or pivotal trials, these studies typically involve large cohorts, ranging from hundreds to thousands of patients diagnosed with the specific disease or condition of interest. The FDA mandates that these trials meet the standard of being “adequate and well-controlled,” employing study designs that facilitate the objective detection of the drug’s effect. The gold standard in this regard is the randomized, double-blind, placebo-controlled trial design, which minimizes selection bias and provides the most reliable method to determine if the investigational drug demonstrates a therapeutic effect. Phase III studies also prioritize the collection of additional safety information, which, when combined with efficacy data, contributes to development of the product’s overall benefit-risk profile.

Phase IV Clinical Trials: Also known as post-marketing studies, these trials are conducted after a product has been commercially launched. These trials carried out as part of a commitment made to the FDA by the sponsor, aiming to gain a better understanding of a product’s risks, benefits, and optimal usage.

Pivotal Studies: These larger-scale trials involve 50 to 500 patients and are specifically designed to provide the primary clinical evidence of safety and efficacy necessary for inclusion in a medical device marketing application submitted to the FDA. This evidence is supplemented by data obtained from the feasibility studies.

Pilot Studies: These are a smaller scale trials that involve 10-30 patients and are designed to provide preliminary evidence of the safety and performance of a medical device.

Post-Market Surveillance Study: After a product is on the market, a study may be required pursuant to Section 522 of the Federal Food, Drug, and Cosmetic Act by the FDA. This mandate applies to Class II or Class III devices meeting specific criteria: the device’s failure could reasonably result in serious adverse health consequences, it is anticipated to have significant use in pediatric populations, it is designed for implantation in the body for more than one year, or it serves as a life-supporting device used outside a device user facility.

Potential Non-Conformity: Logical errors that may arise from future clinical observations of the investigational product.

Professional Care: Also called reasonable care, requires the auditor to conduct an audit carefully and provide an accurate and comprehensive report. 

Protocol: A document that describes the background, objective(s), design, methodology, statistical considerations, and organization of a trial/study.  

Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol

Protocol Deviation: An unplanned excursion from the protocol that is not implemented or intended as a systematic change. A protocol deviation can be categorized into three main types: limited prospective exceptions, subject protection deviations, and other unplanned protocol noncompliance.

Prototype: Researchers build a device prototype, or an early version of a medical device. At this pre-clinical research stage, the device prototype is not for human use. Researchers test the prototypes in controlled laboratory settings. Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. However, it is not possible to eliminate risk entirely.

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Quality Assurance (QA):  In clinical trials, the planned and systematic activities that are conducted to ensure that a trial/study is performed, and that trial/study data are generated, documented, and reported in compliance with the protocol, Good Clinical Practice guidelines, and the applicable regulatory requirement(s). 

Quality Control (QC): In clinical trials, operational techniques and activities undertaken within the quality system to verify that the requirements for quality of the trial/study-related activities have been met.

Quality System: The organization structure, responsibilities, process, procedures, and resources for implementing quality management.

Queries: Questions issued by a monitor to track pending and resolved issues and to document changes to clinical trial data. 

Randomization: The process of assigning trial/study subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. 

Recruitment Rate: The frequency that individuals eligible for a particular study decide to partake in its clinical trial. 

Regulatory Authorities: Bodies having the power to regulate including authorities that review submitted clinical data and those that conduct inspections.  

Regulatory Binder: The file, also known as the Site Master File, that contains all of essential documents to provide a record of study conduct. The Regulatory Binder when reviewed with the clinical charts and archived study materials allows sponsors, auditors, regulators, and all other interested parties to reflect back on a clinical trial and understand how things were conducted, when, and by whom. 

Regulatory Coordinator: An individual who manages regulatory processes across multiple trials in accordance with regulations, organizational policies, standard operating procedures, and study specific protocols. Their responsibilities may include submitting necessary documents/reports to regulatory authorities, maintaining regulatory documents/binders, and ensuring compliance with regulatory and ethical standards. They often work with clinical research coordinators in preparing for monitoring and auditing visits.

Remote Monitoring: Monitoring that occurs remotely and not on-site. In remote monitoring, data entered in case report forms are verified against source documents remotely. For this to occur, a site must upload source documents onto a secure database for the Clinical Research Associate to review. 

Remote Monitoring Plan: Detailed proposals usually developed by the sponsor that employs a risk-based monitoring approach and contains the procedures and protocols for remote monitoring practice (i.e. remote source data verification processes). 

Research Studies: A scientific study of nature that sometimes includes processes involved in health and disease is a research study. Research studies are done to discover new information or to answer a question about how we learn, behave and function with the end-goal of benefitting society. Some studies might involve simple tasks like completing a survey, being observed among a group of people or participating in a group discussion. 

Risk-Based Monitoring: Monitoring that prioritizes the most important data collected in a clinical trial, such as data that supports primary endpoints. Examples include central monitoring, central statistical data checks. 

Serious Adverse Event: An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. 

Site Close-Out Visit: A visit conducted to verify the presence and completeness of appropriate documentation and to ensure that all documents are stored property. This final monitoring visit occurs when all participants are off the study, all study activities have concluded, the case report form for the last participant have been completed, and the site’s Institutional Review Board has been notified of the study closure as appropriate.

Site Initiation Visit (SIV): A visit conducted prior to site activation and before the enrollment of the first participant in the study. The SIV should be conducted after all necessary regulatory documents have been received and/or approved as appropriate. It is preferable for the drug or device to be on-site at the time of the SIV to allow the monitor to verify its availability and accountability. The primary objective is to prepare the site to enroll its initial participants.

Site Master File (SMF): A file composed of regulatory binders and patient binders that document the conduct of the study at the clinical trial site.

Site Monitoring Contingency Plan: Detailed alternative processes and protocols in place if regular site monitoring practices cannot be conducted. 

Site Qualification Visit: A visit conducted by a sponsor representative to assess the overall suitability of the investigator, clinical research team, and clinical trial site for the conduct of the study. This visit occurs before the site selection for a trial.

Source Data Verification (SDV): The process by which data within the case report form or other data collection systems are compared to the original source of information. 

Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept in pharmacy, laboratory, and medico-technical departments involved in the clinical trial). (International Council for Harmonisation Good Clinical Practice Addendum).

Sponsor: Any individual, company, institution, or organization that assumes responsibility for the initiation, management, and/or financing of a clinical trial. (International Council for Harmonisation Good Clinical Practice Addendum).

Sponsor-Investigator: An individual who initiates and conducts, either alone or with others, a clinical trial. Under the immediate direction the Sponsor-Investigator, the investigational product is administered to, dispensed to, or used by a participant. This term specifically refers to an individual and excludes entities such as corporations or agencies. (International Council for Harmonisation Good Clinical Practice Addendum)

Standard Operating Procedure (SOP): In clinical research, the ICH defines SOPs as “detailed, written instructions to achieve uniformity of the performance of a specific function”. 

Study Subject Pool: Individuals deemed eligible for the study; one of the criteria determining whether a site is qualified for participation in the research study.

Sub-Investigator: Any individual member of the clinical trial team designated and supervised by the Principal Investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). (International Council for Harmonisation Good Clinical Practice Addendum) 

Subject Protection Deviations: Deviations necessary to eliminate an immediate hazard to a trial participant or to safeguard the life or physical well-being of a trial participant.

Subject/Trial Subject/Participant/Volunteer/Patient: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (International Council for Harmonisation Good Clinical Practice Addendum)

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Telemedicine/Telehealth Visits: The use of electronic information and telecommunication technologies to support long-distance clinical care, patient and professional health-related education, public health and health administration. 

Tolerability: The quantifiable measurement or degree to which overt adverse effects of a drug can be tolerated by a patient. 

Trial Master File (TMF): A file containing essential documents and other study documents with regulatory agency oversight, retained by the sponsor..

Warning Letters: Letters issued by the FDA to sponsors and investigators who are not in compliance with regulations.

World Health Organization (WHO): A United Nations agency responsible for international public health.