Integration Architecture

The system will have the following integrations.

System (Integration type)	Technology	Description
CDISC Library (External source data)	External restful API using access token for CDISC Library account connected to CDISC membership	CDISC Library holds all CDISC terminology and data exchange standards. Possibility to import relevant standards, or all available standards, from the CDISC Library into the Clinical MDR so these can be referred to from sponsor standards as well as study specifications. See more at https://www.cdisc.org/cdisc-library
Other sources (File based source data)	Data exported from another StudyBuilder environment in JSON format; Or manual exports from external dictionaries with file creation in .csv format; Or manual file based dataset creation in .csv or JSON formats.	The import of dictionary terms from SNOMED, MED-RT, UNII and UCUM. This will either be done by download of files from external dictionary sites (like for UCUM). Alternatively files are created from legacy systems (MED-RT and UNII) or files are created manually based on exported data with manual corrections (e.g. linking Unit Definitions to UCUM).
UNIX SCE & CDW (Internal source data)	Data are extracted from the CDW MDR system using the MEDATA_VIEWER access profile from CDW directly or via UNIX SCE to CDW interface.	In this initial release a subset of sponsor defined standards from the General Clinical Metadata (GCMD) is migrated into the StudyBuilder system.
Word add-in (Internal target data)	Scripting (?) programs within the Microsoft Word connecting to the internal StudyBuilder MDR API	The NN Microsoft Word authoring tool is used for our Common Protocol Template (CPT), this NN CPT will include content controls and importing functionality from the Clinical MDR API populating the structured protocol content defined within the StudyBuilder system.