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Artifacts

Artifacts are records, documents, or files containing any information that is captured during a clinical trial and that meet the purpose or definition described in the DIA RM. In some cases, the artifact is a single document, dataset, or piece of information, but in other cases, it can be represented by multiple document types or data types. These artifacts are stored in the respective folders of your study in Essential Documents.

Artifact list
Figure 1. Artifact list

The Artifact tab displays a list of artifacts in the study. There are two ways of artifact origination in eTMF:

You can perform the following actions with the artifacts:

See also
In this section:

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.