Glossary
Clinical research terminology used across all platform activities. Definitions are aligned with ICH E6(R3) GCP guidelines and regulatory standards.
Adverse Drug Reaction (ADR)
An Adverse Drug Reaction (ADR) is an unintended, harmful reaction that occurs at normal doses of a pharmaceutical product. Understanding and reporting ADRs are critical for patient safety and regulatory compliance.
Adverse Event (AE)
Any untoward medical occurrence in a patient or clinical investigation participant associated with the use of a drug, whether or not considered related to the drug. AEs must be documented throughout the study period as part of safety monitoring.
ALCOA+
Principles for data quality: Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available. The foundation of clinical data integrity.
Audit Trail
A chronological record that provides evidence of changes made to clinical trial data, including who made the change, when, and what was altered. Maintaining an accurate audit trail is key to ensuring compliance and transparency in clinical research.
Bias
Bias refers to systematic errors in the design, conduct, or analysis of a clinical trial that can lead to incorrect conclusions. Understanding and mitigating bias is essential for maintaining the validity and reliability of study results.
Blinded Adverse Event Reporting
A reporting method in which the identities of study participants and treatment assignments are concealed from the assessors reporting adverse events. This approach helps to minimize bias in the assessment of safety data.
Blinding
Blinding refers to the practice of keeping study participants, investigators, or assessors unaware of the assigned intervention to prevent bias in treatment administration and outcome assessment. It strengthens the integrity of clinical trial findings.
Causality Assessment
The process of determining the relationship between an adverse event and the investigational product or intervention. This assessment helps in concluding whether the AE is related to the treatment.
CDISC (SDTM, ADaM, CDASH)
The Clinical Data Interchange Standards Consortium (CDISC) develops standards for data management in clinical trials. SDTM (Study Data Tabulation Model) handles submission data, ADaM (Analysis Data Model) focuses on statistical analysis datasets, and CDASH (Clinical Data Acquisition Standards Harmonization) governs data collection practices.
CFR Regulations
CFR, or the Code of Federal Regulations, encompasses all administrative laws in the United States. Title 21 of the CFR pertains specifically to food and drugs, providing regulations that oversee clinical trials, labeling, and other aspects of drug and device development.
Clinical International Organization for Medical Sciences (CIOMS)
An international non-governmental organization that focuses on the promotion of biomedical research and the protection of human subjects in clinical trials. CIOMS is known for its guidelines on safety reporting and pharmacovigilance activities.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is a comprehensive document that presents the methodology and results of a clinical trial. It is essential for regulatory submissions and must comply with ICH E3 guidelines.
Clinical Trial Registration
Clinical trial registration involves documenting a clinical trial's details in a publicly accessible database prior to its initiation. This practice enhances transparency, promotes accountability, and helps prevent selective reporting of trial outcomes.
Cohort
A cohort is a group of individuals participating in a clinical trial who share a defining characteristic, such as a specific condition or treatment. Cohort studies can help identify associations between exposures and outcomes over time.
Competent Authorities
Competent authorities are national organizations or agencies responsible for the regulation of clinical trials and the safety of pharmaceutical products. They evaluate trial applications and conduct inspections to ensure compliance with national regulations and GCP.
Compliance
Compliance refers to the adherence to applicable regulations, guidelines, and standards in the conduct of clinical research. Achieving and maintaining compliance is essential for ensuring the integrity of research results and the safety of participants.
Control groups
Control groups are groups in a clinical trial that do not receive the experimental treatment but are instead given a standard treatment or placebo. They serve as a comparison to gauge the efficacy of the intervention being tested.
CRA (Clinical Research Associate)
A monitor employed by the sponsor or CRO to oversee the conduct of a clinical trial at a site, ensuring data quality and GCP compliance.
CRF (Case Report Form)
A paper or electronic form used to collect data for each trial participant according to the protocol.
CRF/eCRF
Case Report Form (CRF) is a document used to collect data from each trial participant, whereas an Electronic Case Report Form (eCRF) digitizes this process, facilitating data entry, storage, and management. Both forms are vital for regulatory submissions and must adhere to GCP standards.
Data Integrity
Data integrity refers to the accuracy, completeness, and consistency of data collected in clinical trials. Maintaining data integrity is crucial for ensuring the validity of study results and compliance with regulatory standards.
Data Interchange Standards
Standards that facilitate the exchange of clinical trial data between different systems or organizations. These standards ensure consistency and reliability in data reporting and regulatory compliance.
Data Management Plan (DMP)
A formal document that outlines how data will be collected, managed, and analyzed during a clinical trial. The DMP includes protocols for data entry, validation, storage, and sharing to ensure compliance with regulatory requirements.
Data Privacy
The protection of personal and sensitive information collected during clinical trials, governed by regulations such as GDPR and HIPAA. Data privacy ensures that participant data is handled with care and used only for approved research purposes.
Data Reconciliation
The process of comparing and correcting discrepancies between different data sources in a clinical trial, ensuring that the reported data is complete and consistent. This process is essential for achieving high data quality.
Data Safety Monitoring Board (DSMB)
An independent group of experts that monitors patient safety and treatment efficacy data during a clinical trial. The DSMB provides recommendations on whether to continue, modify, or stop the trial based on data reviewed.
Data Validation
The process of ensuring that data is accurate, complete, and reliable before it is used for analysis and reporting. Data validation can include automated checks and manual review and is essential for maintaining data integrity.
Database Lock
The point at which all data in a clinical trial database are declared final and no further changes are permitted without formal authorization.
EDC (Electronic Data Capture)
A computerized system used to collect clinical trial data in electronic format, replacing or supplementing paper CRFs.
EDC Systems
Electronic Data Capture (EDC) systems are software applications that facilitate the collection and management of clinical trial data in electronic format. These systems streamline data entry and improve data accuracy and accessibility for study teams.
Endpoints
Endpoints are the primary and secondary outcomes that a clinical trial is designed to measure. Primary endpoints are the main outcomes of interest, while secondary endpoints provide additional information regarding the effects of the intervention.
Enrollment
The stage in a clinical trial when eligible participants formally consent and enter the study. This step is critical for establishing the cohort that will receive the investigational treatment and be monitored for outcomes.
Estimands
Estimands are precise definitions of the target quantity of interest in a clinical trial under specific conditions. They help in clarifying the treatment effect that the study is designed to estimate, ensuring that data is analyzed appropriately.
Expedited Reporting
A process that involves the rapid notification of serious and unexpected adverse events (SAEs) to regulatory authorities, investigators, and ethics committees. This is critical to ensure prompt assessment of risks and implementation of protective measures.
Exploratory endpoint
Exploratory endpoints are outcomes that are defined after the start of the trial or are not pre-specified in the study protocol. They are used to generate hypotheses for future studies or provide preliminary data for new insights.
Feasibility
Feasibility refers to the practicality and viability of conducting a clinical trial, considering factors such as recruitment potential, capacity for data collection, and adherence to study protocols. A feasibility study may be conducted prior to the main trial.
GCP (Good Clinical Practice)
An international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
GCP Principles
Good Clinical Practice (GCP) principles are a set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. They ensure that the rights, safety, and well-being of trial participants are protected.
ICF (Informed Consent Form)
The document used to obtain a participant's voluntary agreement to participate in a clinical trial, after being fully informed of the nature, risks, and benefits of participation.
ICH Guidelines
International Council for Harmonisation (ICH) guidelines provide a framework for the development, registration, and monitoring of pharmaceuticals and biopharmaceuticals. They aim to ensure that clinical trials are conducted in a scientifically valid and ethically acceptable manner across different countries.
IND (Investigational New Drug)
An application to the FDA to authorize shipment of an investigational drug across state lines for clinical investigation purposes.
Informed Consent Process
A systematic approach ensuring that potential research participants are adequately informed about the study's purpose, procedures, risks, and benefits. It must be documented and includes obtaining documented consent from each participant prior to enrollment, aligning with regulatory requirements.
Inspections
Inspections are regulatory evaluations conducted by health authorities to assess compliance with GCP and other regulatory requirements. These evaluations often focus on trial sites, sponsors, and institutional review boards to ensure adherence to established standards.
Interim Analysis
An analysis performed on data collected before the completion of a clinical trial, often used to assess treatment effects or study progress. Interim analyses may lead to early termination or modification of the study based on predefined criteria.
Intervention
An intervention is an action taken to improve or alter the outcome of a health condition, such as a drug, therapy, or surgical procedure. Defining the intervention clearly is a key component of the study design to evaluate its effectiveness accurately.
Investigational Product
Any medication, device, or other intervention being tested in a clinical trial. The investigational product may be a new drug, a device not yet approved for marketing, or a combination of products.
IRB / IEC
Institutional Review Board (US) or Independent Ethics Committee (International) — the body responsible for reviewing and approving research studies to protect the rights and welfare of human participants.
Last Patient, Last Visit (LPLV)
The point in a clinical trial when the last participant has completed their last visit. LPLV is significant for timing the end of data collection and begins the analysis phase of the trial.
Longitudinal Data Collection
The process of collecting data from the same subjects repeatedly over a specified period. This approach is vital in clinical trials to assess changes in health status or treatment responses over time.
Monitoring Visit
A scheduled visit conducted by clinical trial monitors to ensure compliance with the protocol, GCP, and regulatory requirements. These visits assess data integrity, participant safety, and the overall conduct of the trial at the site.
Periodic Safety Update Report (PSUR)
A comprehensive report that summarizes the safety data of a drug therapeutic product over a defined period, including analyses of benefits and risks. PSURs are submitted periodically to regulatory authorities as part of ongoing pharmacovigilance.
Pharmacovigilance
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Effective pharmacovigilance systems are vital for regulatory compliance and ensuring drug safety post-marketing.
PICO
Framework for formulating clinical research questions: Population, Intervention, Comparator, Outcome.
PICO framework
The PICO framework is a structured approach used in clinical research to formulate research questions. It stands for Patient/Population, Intervention, Comparison, and Outcome, and helps in designing studies that clearly define objectives and measures of success.
Post-Market Surveillance
The process of monitoring the safety and effectiveness of a drug after it has been released on the market. This activity helps ensure ongoing assessment of risks and safety signals based on real-world use of the drug.
Pre-Approval Inspections
Pre-approval inspections are regulatory reviews conducted prior to the approval of a new drug application. These inspections assess compliance with GCP, the integrity of the data submitted, and the appropriateness of the trial conduct.
Primary endpoint
The primary endpoint is the main result that is measured at the end of a study to determine the effectiveness of a treatment. It is predefined in the study protocol and is the primary outcome used for statistical analysis.
Principal Investigator (PI)
The person responsible for the conduct of a clinical trial at a trial site.
Protocol amendments
Protocol amendments are changes made to the study protocol after its initial approval. These amendments must be submitted for regulatory review and may pertain to objectives, endpoints, or other aspects of the study design.
Protocol Deviation
Any change or departure from the approved study protocol that has not been approved in advance by the IRB/IEC, sponsor, and/or regulatory authority.
Query Management
A systematic process for identifying, addressing, and resolving discrepancies or missing data in clinical trial datasets. Effective query management is crucial for ensuring that data is accurate before analysis and reporting.
Randomisation
Randomisation is the process of assigning participants to different intervention groups using random methods to minimize bias and ensure comparability between groups. It is a crucial aspect of clinical trial design to validate the results statistically.
Randomization
The process of assigning participants to treatment groups by chance, eliminating selection bias in clinical trials.
Regulatory Framework
A regulatory framework outlines the laws, regulations, and guidelines that govern the conduct of clinical research in a specific jurisdiction. It provides a structured environment ensuring that trials are conducted ethically and safely.
Regulatory Submissions
Regulatory submissions involve the formal presentation of data and documentation to regulatory authorities for the approval of new drug applications, investigational new drug applications, or other regulatory filings. These submissions must comply with specific formatting and content requirements.
Risk Evaluation and Mitigation Strategies (REMS)
A strategy to manage known or potential serious risks associated with a drug through specific measures that may include restricted distribution, special communications to healthcare providers, and patient enrollment conditions.
Risk Management
A systematic approach to identifying, assessing, and mitigating the risks associated with drug treatments. This includes developing risk minimization plans and monitoring their effectiveness post-marketing.
Risk-Based Monitoring
Risk-based monitoring is an approach that focuses resources on the highest-risk aspects of a clinical trial to ensure participant safety and data integrity. It involves continuous assessment and prioritization of monitoring activities based on pre-defined risks.
SAE (Serious Adverse Event)
An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in persistent or significant disability, or is a congenital anomaly/birth defect.
Safety Monitoring
The ongoing evaluation of the safety profile of a drug or intervention throughout the clinical trial process. It includes the systematic collection and analysis of safety data to identify any potential risks to participants.
Safety Protocol
A detailed plan that outlines the processes to monitor, report, and evaluate the safety of the investigational product during a clinical trial. This protocol ensures that safety assessments comply with regulatory standards.
Sample size
Sample size refers to the number of participants required for a clinical trial to achieve reliable and statistically valid results. Determining the appropriate sample size is critical for ensuring that the study can detect a meaningful difference between treatment groups.
Screening
The process of determining the eligibility of potential participants for a clinical trial based on predetermined inclusion and exclusion criteria. Screening involves collecting data from the participants that will inform their suitability for enrollment in the study.
Secondary endpoint
Secondary endpoints are additional outcomes that are of interest in a clinical trial but are not the main focus. They help to provide further insights into the treatment effects and support the findings of the primary endpoint.
Signal Detection
The process of identifying new or rare safety signals from a collection of data related to drug safety. It involves statistical analysis and a thorough review of reported adverse events to recognize potential risks.
Site Close-Out
The final stage of the clinical trial at a specific site, involving the completion of all required activities, documentation, and regulatory submissions. Site close-out ensures all data is accounted for and that the site meets GCP requirements upon study completion.
Source Data
The original data collected during a clinical trial, which serves as the foundation for all subsequent data points and analyses. It includes data captured in source documents such as laboratory results, medical records, and participant questionnaires.
Source Data Verification (SDV)
The process of verifying that the data recorded in study documents matches the source data. SDV is essential for ensuring data accuracy and integrity in clinical trials.
Spontaneous Reporting System
A system used for collecting information on adverse events that are reported voluntarily by healthcare professionals or patients. It serves as an important tool for ongoing pharmacovigilance and safety signal detection.
SUSAR
Suspected Unexpected Serious Adverse Reaction — an SAE that is both unexpected (not in the IB) and possibly related to the investigational product.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
An adverse reaction that is both serious and unexpected, related to the investigational drug. SUSARs require expedited reporting to regulatory authorities and must be monitored closely to manage patient safety.
Trial Master File (TMF)
A comprehensive collection of essential documents that facilitate the management of a clinical trial and demonstrate compliance with GCP and regulatory requirements. The TMF must be maintained and updated throughout the study and needs to be ready for inspection by regulatory authorities.