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An international standard for the transmittal of electronic safety data signed as an ICH Step 4 document in July 1997.

An ICH standard that is used for the electronic transmission of the adverse event information to ensure the efficacy of the clinical trial. The standard is used by the PV application.

An electronic version of a CRF that is a specialized document in a clinical trial designed to collect subject's data.

An eClinical mobile application designed for the collection of clinical outcome assessments, such as patient-reported outcomes, questionnaires, and other data related to the participant's health, symptoms, or treatment experiences.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

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

In the clinical research industry, a software that is used to collect and store subject data in the clinical trial process in a permanent electronic form.

A service provided by EDETEK to facilitate exchanges of information, such as XMLs. This can either be data transmitted by external groups outside of EDETEK to be received by the EDETEK team (for example, migration of cases from other databases to be entered in the EDETEK PV system), or data to be sent out by the EDETEK team to external parties (for example, submission of cases to regulatory authorities or other companies via gateway).

A software that provides communication solutions with customers, suppliers, and other partners via the electronic exchange of business documents and transactions in a simplified fashion.

An eClinical mobile application used for the collection and management of clinical data of subjects, supporting iOS and Android systems. It is based on the electronic CRF provided by the Study Designer application to support subjects' self-recording of treatment and diagnosis information.

An electronic version of a trial master file (TMF) is a type of content management system for a clinical trial used to organize and store files required for compliance with government regulatory authorities like the FDA, EMA, or others.

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

An action of including a subject in a clinical trial, provided that they have met the inclusion criteria to participate in the trial and have signed an informed consent form.

A type of documentation in the clinical trial that permits the quality evaluation of the clinical trial's conduct to ensure that the collected data is credible and the participants' trial rights and well-being are protected.

These documents include: Trial Protocol and Amendments, Investigator’s Brochure (IB), Informed Consent Form (ICF) and any updates, Ethics Committee (EC)/Institutional Review Board (IRB) Approval, Curriculum Vitae (CVs) of Investigators, Clinical Trial Agreement, Financial Disclosure Forms, Insurance Statement, Regulatory Authority Authorization, and Laboratory Certification/Norms.

A decentralized scientific agency that regulates the evaluation and supervision of the manufacture of medical products in Europe.

Learn more about EMA on its official website.

In pharmacovigilance, expedited or non-expedited reporting means how quickly the Individual Case Safety Report (ICSR) must be submitted to regulatory authorities based on its seriousness, expectedness, and causality. Expedited cases are urgent and usually reported within a timeline established by regulatory authorities. Non-expedited reports are not urgent and can be submitted with periodic safety reports.