Mandatory data mappings
This page details some key things to note when mapping mandatory Adverse Events data and an example video.
In the Adverse Events (AEs) mappings table what is represented in the Source data column field from the source data file and the Aggregation functions play a key role in successful loading of data
AE Mapping table
When mapping source data columns to the mapping table ensuring the fields are populated with the correct data and that the data is in the format required for the mapping field - text, numeric, date or time is important
Data fields requiring dates - from the aggregation functions select the date format that is represented in the source data file
Maximum severity grade for this field the Source data column in the mappings table will be populated with multiple column names from the source data file.
All the columns in the source data file containing AE grade changes must be mapped, including the column which contains the starting severity grade
Note: when adding multiple column names from a source data file in the Source data column each column name is followed by a comma and space - example: AE_SSG, AESGC1, AESGC2,
Aggregation functions: Max value should be selected for the data field Maximum severity grade. This will allow the system to identify the maximum severity grade of an AE for a particular subject
Saving the mappings results in the maximum severity grade field being highlighted pink - this is a prompt to check this field is correctly populated as it's populated with several source data file column names. Note: the field is highlighted pink even if the mappings are correct
TRAINING VIDEO: This video walks through an example of mapping mandatory AE data, highlighting the areas above
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