SEND XLSX and SEND XLSX Connectors

SEND XLSX and SEND XLSX Secondary connectors are available for use with SEND Explorer Warehouse and are available as part of the standard installation starting with V12. These connectors can be used to import data for studies that are not available in SEND XPT format, update/replace studies in SEND XPT format, or augment data for studies that are already loaded into SEND Explorer, such as to add specialty lab data, concentration or toxicokinetic data, etc.

SEND XLSX and SEND XLSX Secondary connectors work with Excel templates that have worksheets for each SEND domain and include the applicable variables. The "full" SEND XLSX template includes all columns listed for each domain in the SEND Implementation Guide. Columns headers are color coded to indicate permissibility. The "abbreviated" SEND XLSX template includes a subset of domains/variables that are required for loading study data into SEND Explorer or used specifically in SEND Explorer views and visualizations. Each template contains a ReadMe worksheet with helpful information including rules and tips on how to enter data into the templates. This information should be reviewed carefully before using the templates. Of note, all dates in the SEND XSLX templates must be entered in ISO 8601 format and columns set to Text format. The full and abbreviated SEND XLSX Excel templates are available by request from Certara support at support@certara.com.

Any study loaded into SEND Explorer Warehouse can be exported in SEND XLSX format. Click on the hyperlink for the study in the SEND Explorer Dashboard and then select Export to Excel button from the top of the Study Overview page. The full SEND XLSX format file for the study will be exported to the local Downloads folder.

The SEND XLSX connector must be installed in the SEND Explorer Warehouse instance prior to use. Users with permissions of Data Steward or Administrator can confirm if this connector is available by clicking on the top Data Steward menu, then Source Systems. SEND XLSX and SEND XLSX Secondary connectors will be listed in the Source Systems table if they are installed. Additionally, the Active column for each connector must be set to "Y."

SEND XLSX is a primary data source and must include the required trial and metadata domains. It can be uploaded by users with permissions of Data Steward or Administrator using the Upload Study Data or Upload to Watch Folder buttons on the SEND Explorer Dashboard, selecting the SEND XLSX Source System and browsing to locate and select the SEND XLSX file to upload. The uploaded file will be added to the load queue and will be loaded with the next load cycle. To use Watch Folders, a Watch Folder specific to the SEND XLSX source system must be present and active in the system. If you do not have a Watch Folder setup for the SEND XLSX source system, contact Certara support to get it added.

Following upload of the SEND XLSX data and completion of load cycle, the study will be hyperlinked in the SEND Explorer Dashboard and all uploaded data available for data analysis/visualization.

If there is already a SEND 3.x version of a study loaded into SEND Explorer, upload of data for that same study in SEND XLSX format will not replace the existing SEND 3.x XPT data but will be loaded as duplicate data for the study. To replace a loaded SEND 3.x XPT study with SEND XLSX data, the SEND 3.x XPT study must be deleted from SEND Explorer prior to upload of the SEND XLSX data.

If SEND XLSX is the primary data source for a study already loaded into SEND Explorer, data can be updated in the existing SEND XLSX file and reloaded. Any additional or updated records will be handled as part of the upload process and available in the system following reloading of the study.

Secondary data in SEND XLSX format can be uploaded to augment findings data for studies already loaded into SEND Explorer Warehouse from primary data sources like SEND 3.x or Pristima. The SEND XLSX Secondary source system cannot be used for primary studies in SEND XLSX format. To add or update data for primary studies in SEND XLSX format, edit the data in SEND XLSX format and reload to SEND Explorer.

The SEND XLSX full or abbreviated template can be used for creation/input of SEND XLSX Secondary data, but only the worksheets for findings domains that contain new domains or additional findings data for existing domains should be included in the Excel file uploaded into SEND Explorer Warehouse. If records are being added to domains already loaded for the study in SEND Explorer, --SEQ values must not conflict with those assigned to already loaded records.

Secondary study data can be uploaded using the SEND XLSX template by users with permissions of Data Steward or Administrator using the Upload Study Data or Upload to Watch Folder buttons on the SEND Explorer Dashboard by selecting the SEND XLSX Secondary Source System and browsing to locate and select the secondary SEND XLSX file to upload. The upload file will be added to the load queue and will be loaded with the next load cycle. To use Watch Folders, a Watch Folder specific to the SEND XLSX Secondary source system must be present and active in the system. If there is not a Watch Folder setup for the SEND XLSX Secondary source system, contact Certara support to get it added.

Following upload of the SEND XLSX Secondary data and completion of load cycle, the study will appear as hyperlinked in the SEND Explorer Dashboard and secondary data uploaded available for data analysis/visualization.