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What's in the data sets used to process data transmissions?
The InForm and Oracle Argus Safety integration software uses the following data set definitions and system data sets to process data transmissions:
- Safety_Config
- Safety_Significant
Safety_Config
The Safety_Config data set identifies items and forms used by InForm Publisher for safety processing. For example, the Safety_Config data set includes a required data series mapped to a control in the AE form so that InForm Publisher can identify the AE forms in the study.
in the Safety_Config data set
Characteristics |
Description |
|---|---|
Any AE Form Control |
Use to identify the AE form. Map this data series to any item on the AE form. Required. |
Any SE Form Control |
Use to identify the Safety Case form in a design with separate AE and Safety Case forms. Map this data series to any item on the Safety Case form. Required in a design with separate AE and Safety Case forms. |
SE Related AE Sequence Number Control |
Item on the Safety Case form containing the sequence number of the AE instance for which the Safety Case was entered. Required in a design with separate AE and Safety Case forms. Map the item on the Safety Case form. This form collects the sequence ID of the AE form. If this is mapped to an item in a repeating itemset, then timeframes will not be used for related AEs. |
AE Start Date Control |
Onset date of the AE. This data series is used to identify by date range the related safety event data that appears on other forms. |
RelatedDynamicGrid |
Identifies the dynamic grid. |
AE IsSerious Control |
Shows where the IsSerious checkbox resides on the form. |
AE IsReportable Control |
Shows where the IsReportable checkbox resides on the form. |
Safety_Significant
The Safety_Significant data set is an empty data set in which you must create the data series and mappings for items that are monitored for changes after initial transmission to determine whether follow-up transmissions are needed. The items mapped to data series in the Safety_Significant data set are considered significant for safety and trigger a follow-up transmission when changed.
Note: Compound items can include both items that are mapped as significant in the Safety_Significant data set and items that are not mapped as significant. When any item in a compound item is updated, all items in the compound item are updated, and, therefore, even an update to a non-significant item triggers a follow-up transmission.
The data series in the Safety_Significant data set are a subset of the data series in the data sets that make up the main message body sent to Argus Safety. Every item that is mapped in the Safety_Significant data set must also be mapped in the message body data sets.
Additionally, the data series in the Safety_Significant data set must have the same aliases as the corresponding data series in the message body data sets. Therefore, copy and pasting data series from the message body data sets into the Safety_Significant data set is recommended.
