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In pharmacovigilance, an official communication method for sponsors, regulatory authorities, and stakeholders to exchange information on the successful receipt or failure of the ICSR or other safety data and regulatory submission.

In CTMS, an instance created to address issues or discrepancies discovered during a monitoring visit. One issue may have several action items associated with it because a resolution of a single issue may require several steps.

In pharmacovigilance, the main biologically active component or substance responsible for the therapeutic effect of a pharmaceutical product. The API is the key ingredient in a medication that provides the intended therapeutic benefit. It is also known as the drug substance.

A task or process in a clinical trial carried out during a study to ensure its progress and compliance. These activities can include patient screening, drug administration, data collection, site monitoring, and regulatory reporting. Each activity follows a defined protocol and contributes to the overall objectives of the trial.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

Any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any 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.

A configurable notification sent to interested parties via email to update them on the user actions, system events, and other occurrences in the system.

A type of marker for a visit that designates when a specific visit is expected. With a corresponding SD functionality, depending on the anchor assigned to the visit, the visit window with the prescribed activities is calculated.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

A component of the dynamic randomization algorithm that determines the treatment arm to which a new participant is allocated based on certain predefined criteria or rules.

In eTMF, the lowest level of the file directory predefined by the Drug Information Association Reference Model (DIA RM). Artifact-level folders exist within a section and store individual documents—the actual files related to the clinical trial that are stored in the eTMF system.

A documentation that descriptively records all the operations made with a certain entity in the system. Keeping the audit trail makes it possible to reconstruct the course of events, and in the clinical trial industry, the lack of the audit trail can be considered a serious breach of data integrity.