O

In eTMF, a term referring to both files and folders that you can store and manage within the application.

A standardized data model developed by CDISC to provide vendors with a structured way to represent, store, archive, and share the clinical trial data and metadata. The ODM file in the XML format allows for preparing and maintaining study design, forms, and items, keeping audit trails, and other aspects for efficient and consistent data exchange between systems (like SD and EDC), stakeholders, regulatory authorities, and more.

An integration type based on which the system sends the order file generated for the supply shipments in IWRS to the vendor's server for data exchange purposes.

A document is also called a source document. It contains personal subjects' data, such as lab results, hospital records, patient diaries, and so on. Such source documents are a component of the Trial Master File (TMF). Source documents play a critical role in recording treatment cycles, ensuring the accuracy, integrity, and overall compliance of the clinical trial data.