Configuring eMDR Blank Values
Use these steps to manage blank values for eMDR submissions. When the eMDR is submitted through the FDA gateway, these values determine how the gateway interprets each blank field. It can be interpreted as an unknown, missing, not applicable, or undefined value.
1. In the Navigator, select Quality > Utilities > eMDR Blank Value Configuration.
2. For each value on the report, select one of the following to set the default meaning if that field is left blank:
No Information—The answer could be available, but no information was provided.
Asked But Unanswered—The question was asked but the answer is unknown.
Leave Blank—Shows as a blank value on the report.
Not Applicable—This question does not apply to the situation.
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When filling out a particular eMDR, the user can modify the meaning of each blank value if it varies from the default chosen in the eMDR Blank Value Configuration. For more information, see Creating or Updating an eMDR.
3. Click OK.
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