Associate Sender-defined Keywords to an Assembly Folder

Associate Sender-defined Keyword entity to an assembly folder with specific Context of Use code (CoU) to improve the data quality and follow the eCTD 4.0 specification requirements.

Prerequisites

You can associate or disassociate the Sender-defined Keywords (SDKs) to sequence assembly folders if they are one of the following: 2.3.S, 2.3.P, 2.3.A.1, 2.3.A.2, 2.7.3, 3.2.A.1, 3.2.A.2, 3.2.A.3, 3.2.S, us_1.15.2.1.1. Depending on the controlled vocabularies provided by the regulatory agency, this list can change.

You can edit the SDK values based on the application level.

To associate SDKs:

  1. Select the folder with specific Context of Use Code and click Edit .
  2. In the Context of Use Code field, select the required value.
  3. Click Save.
  4. Click More > Additional Information.
  5. Find the required keyword using the widget.

    All the SDK values available for the application are displayed.

  6. If required, enter some symbols to search values by some criteria.
  7. Select the keyword and close the widget.
  8. Save.