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Map repeating data sets to items that can occur multiple times in a message
The data series in repeating data sets are mapped to items that can occur multiple times in a safety event transmission message. You can map these data series to items in repeating sections, forms, and visits. Each data series in a repeating data set must be mapped to the same repeating section, form, and visit. When a form containing repeating data is submitted, the safety event transmission message includes the mapped data from all applicable instances of the form.
Note: If you have configured InForm Publisher to select related data based on dates, the configuration may affect the number of instances that are sent in a safety event transmission message. For example, multiple AEs might be sent with the submitted AE if their dates are within the configured range for related data.
Only the following data sets are repeatable:
- Subject_AdverseEvent
- Subject_ConMed
- Subject_LabTest
- Subject_MedicalHistory
- Subject_PastDrugHistory
- Subject_SuspectDrug
Map the data series in the following data sets to the same form as the Subject_ SuspectDrug data set:
- Subject_SuspectDrug_ReactionRecurrence
- Subject_SuspectDrug_ReactionRelatedness
- Subject_Death
Map the data series in the following data sets to the same form as the Subject_Death data set:
- Subject_CauseOfDeath
- Subject_Autopsy
Note: The amount of data copied onto the Safety Case form differs based on the type of source form. For example, for adverse events, copy over only the information the site needs to confirm that they selected the correct AE. All other information does not need to be copied for AEs. For AEs, the data can be split between forms to go to Argus Safety if you are using InForm Publisher 2.1.1 or higher.
You must put ALL items that need to go to Argus Safety on the Safety Case form.
If an item occurs in multiple forms or visits, you can map a data series to the item in a specific form or in a specific form and visit by on the Data Series Summary tab of the form or study event.
You can map multiple items to the same data series, and you can map similar items from different forms to the same data series in a repeating data set. For example, you can map items from a Lab Local and a Lab Central form to the same data series in the Subject_LabTest data set. When you do this, the safety event transmission treats the items as coming from different instances, so the transmission message contains a different element for each form.
Note: The mappings need to be in the same order for each element. For example, if you map Lab Name and Test Date to LabLocal and LabCentral, both Name and Date need to appear in the forms in the same order.
