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In relation to a clinical trial, a person who represents the interests of the study subject and helps them with their study-related activities that they cannot manage themselves. The caregiver may be a person legally in charge of the vulnerable populations (children, elderly, severely ill patients, and so on) or informants who help collect data on the subject's conditions throughout the trial.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

As part of the U.S. Food and Drug Administration (FDA), ensures that safe and effective drugs are available for people's health improvement. Learn more on the CDER official website.

A standardized form issued by CIOMS used in pharmacovigilance for reporting adverse events and collecting other essential information, including details on patient demographics, medical history, concomitant medications, description of the adverse event, treatment received, and outcome. Learn more and download the reference form on the official website.

A model describing the foundational structure for the organization, naming, and description of variables and associated attributes to support data collection in clinical trials. 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.

A collection of standards that is required for the regulatory submissions to FDA or PMDA. Learn more on the CDISC official website.

A person responsible for overseeing and monitoring a clinical trial to ensure it is conducted in compliance with regulatory standards and protocols. The CRA’s scope of work might include protocol review, site selection and initiation, monitoring, data entry control, and more.

In the eClinical system, the Clinical Research Associate (CRA) user role is assigned to a person who works with the sites, and in EDC, mainly has to make sure that the entered data is truthful to the source document. CRA checks the source document in a process called source data verification and ensures that everything entered by the clinical research coordinators is valid to avoid any discrepancies caused by human errors.

A person responsible for the successful planning, execution, and management of clinical trials. The CRC’s scope of work might include study preparation, site setup, patient recruitment, regulatory compliance control, data collection, and more.

In the eClinical system, the Clinical Research Coordinator (CRC) user role is granted to a person who works on a site with subjects and is responsible for entering data to EDC, ensuring the data is entered correctly according to all requirements, and answering queries from data managers on any questionable data pieces.

In a clinical trial, a CSR is a comprehensive document about the methods and results of the trial.

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

Get to know all the possibilities of the app with the comprehensive CTMS User Guide.

A predefined list of standardized codes representing specific responses or data points, ensuring consistency in data collection, making the records comparable across different subjects or time frames. In eClinical, codelists are configured in multiple apps for further reuse in various form designs, such as case report forms (CRFs) in SD, trip report forms in CTMS, and so on.

An eClinical application that is intended for medical coding and managing elements of data collected during clinical trials to organize large amounts of information in a standardized way—according to WHODrug and MedDRA dictionaries. The application facilitates data analysis and ensures accuracy and consistency in reporting.

Get to know all the possibilities of the app with the comprehensive CODING User Guide.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

A scalable platform for the execution of data and metadata management activities, data transformations, data storage, and data quality provision.

A document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved.

This organization is hired by pharmaceutical, biotechnology, or medical device companies to manage and conduct various aspects of clinical trials. CROs offer a wide range of services, including trial planning, execution, monitoring, data management, and regulatory support.

A hierarchical unit used to group and manage investigational products (IMPs) and placebos for shipping and inventory purposes. For example, large boxes and medium boxes.

An international, non-governmental, non-profit organization established jointly by WHO and UNESCO. CIOMS is represented by its member organizations, which include many biomedical disciplines, national academies of sciences, and medical research councils aimed to advance public health through guidance on health research and policy including ethics, medical product development, and safety. CIOMS is in official relations with WHO and is an associate partner of UNESCO. Learn more on the CIOMS official website.

A Lowest Level Term (LLT) that is still valid and not retired in the latest version of the MedDRA dictionary.

A specific period within the clinical trial during which certain activities or interventions occur. Clinical trials are conducted in multiple phases, each consisting of several cycles, depending on the study design and the specific protocol.