An unwanted or harmful reaction that occurs after the administration of a drug or medical product.

Any untoward medical occurrence or side effect that happens to a participant during the course of a clinical trial or after the administration of a drug.

Allowing participants to use their own smartphones, tablets, or other electronic devices for data collection in a clinical trial.

An organization responsible for coordinating and managing the activities of multiple clinical trial sites.

A global nonprofit organization that develops and promotes standards for data collection, representation, and exchange in clinical research.

The process of collecting, cleaning, validating, and managing clinical trial data to ensure its quality and integrity.

A set of regulations issued by various government agencies that govern the conduct of clinical trials in the United States.

The branch of pharmaceutical development that focuses on the chemistry, manufacturing processes, and quality control of drug products.

A company that provides various services to pharmaceutical, biotechnology, and medical device companies to support their clinical trial activities.

A legally binding agreement between the sponsor and the clinical trial site, outlining the terms and conditions of the trial.

A software system that facilitates the management and tracking of various aspects of a clinical trial, such as participant enrollment, data collection, and study timelines.

A document used to resolve discrepancies or clarify queries related to data collected during a clinical trial.

The effect of one drug on the efficacy or toxicity of another drug when they are administered together.

The process of electronically capturing and entering data directly into a database or electronic system, eliminating the need for manual transcription.

An independent committee responsible for monitoring the safety and efficacy data during a clinical trial and providing recommendations to ensure participant welfare.

A visit conducted by the sponsor or monitor to review and ensure the accuracy, completeness, and integrity of data collected during a clinical trial.

The use of electronic systems to capture, store, and manage clinical trial data, replacing traditional paper-based methods.

The use of electronic devices or platforms to collect patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, or performance outcomes in a clinical trial.

A repository or collection of electronic clinical outcome assessment instruments, resources, and information to support the implementation of eCOA in clinical trials.

The use of electronic platforms or systems to present and obtain informed consent from participants in a clinical trial.

The regulatory agency responsible for the evaluation and approval of medicines in the European Union.

The regulatory agency responsible for protecting and promoting public health by regulating and supervising food, drugs, medical devices, and other products in the United States.

A set of principles, guidelines, and standards that define best practices for data management in clinical trials.

International ethical and scientific quality standards for the design, conduct, recording, and reporting of clinical trials.

A set of guidelines and practices that ensure the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

The impact of a medical condition or treatment on a person's physical, mental, and social well-being.

A document that provides potential participants with comprehensive information about the clinical trial, including its purpose, procedures, risks, and benefits, and seeks their voluntary agreement to participate.

An international organization that develops and promotes harmonized guidelines for the registration, evaluation, and post-approval of pharmaceutical products.

A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial.

A new drug or biologic that is being investigated in a clinical trial but has not yet been approved by regulatory authorities for marketing.

An independent ethics committee responsible for protecting the rights, safety, and well-being of human subjects participating in clinical trials.

A computerized system used to manage and control the randomization, drug supply, and data collection aspects of a clinical trial.

The highest dose of a drug or treatment that can be administered without causing unacceptable side effects or toxicity.

The study of how drugs are absorbed, distributed, metabolized, and eliminated by the body, as well as their pharmacological effects.

The individual responsible for the overall conduct and management of a clinical trial at a specific site.

Refers to a clinical trial design where one group of participants receives a placebo (inactive substance) while another group receives the active treatment being studied.

Objective measurements or assessments used to evaluate a participant's physical or functional abilities in a clinical trial.

Measures of health or treatment outcomes reported directly by the patient or participant, capturing their subjective experiences and perspectives.

The processes and procedures implemented to ensure that data, materials, products, or services meet defined quality standards.

The systematic processes and activities implemented to ensure that quality standards are met throughout the conduct of a clinical trial.

The process of creating and improving products or processes through scientific and technological innovation.

A documented plan that describes the identification, assessment, and control of risks associated with the use of a drug or medical product.

Any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

The process of reviewing and confirming the accuracy and completeness of data entered into a clinical trial database by comparing it with the original source documents.

A visit conducted by the sponsor or monitor to initiate a clinical trial at a study site, including training and ensuring site readiness.

A documented step-by-step procedure that describes how specific tasks or activities should be performed in a consistent and standardized manner.

The graphical or visual elements and design that allow users to interact with a software application or system.

The overall experience and satisfaction a user has when interacting with a product, system, or service, taking into account factors such as usability, functionality, and aesthetics.