Calyx RIM Administration

Prepare for Bulk eCTD Import

The Bulk eCTD Import process matches the Application Code within the XML being imported. This process is executed by a job named Preparing for Bulk eCTD Import. This job finds all valid applications in the source folder and parses

regional.xml files to find an application number to match with an application code in Calyx RIM.

When you click on the details of the Preparing for Bulk eCTD Import job, you will see messages that show the matching application code found in the system. This is the application where the imported sequences are located. 

Bulk Import Prerequisites

The appropriate Application must exist in  Calyx RIM prior to performing a bulk eCTD import, you will need to create the applications before performing the bulk import.

If the system encounters a sequence folder without a valid 'util' folder, sequence XML, or valid regional XML file during the bulk import process, the following message appears: "WARNING: The Application located here:"<path to application>" failed to import: Required files were not found, ensure all Sequence folders contain a valid 'util' folder, and/or XML file."

Applications Other Than US 3.3

For Applications other than US 3.3 Applications, the Preparing for Bulk eCTD Import job will look in the Sequence folder with the highest sequence number first. This is to account for Europe’s "UNKNOWN" Submission Number in early sequences. To ensure a successful import, set the Application Code within Calyx RIM to the Application Code/Application Number/Application Tracking Number in the last XML in the Application folder.

When there is no regional.xml in the folder with the highest sequence number, or when there is a regional.xml without an Application Code/Application Number/Application Tracking Number, the system checks the folder(s) with the previous sequence number - continuing until the Application Code/Application Number/Application Tracking Number is found. If no Application Code/Application Number/Application Tracking Number is found, the application is skipped and the following message appears in the log: "WARNING: The Application located here: "<path to application>” failed to import: The Application Code was not found in the regional.xml, please ensure that folder contains a valid application."

GCC, MRP, DCP Applications

For GCC, MRP, and DCP, multiple Application Codes can exist for the same Country, or for different Countries within the XML. The list of all application codes within the XML is matched against an Application Code within Calyx RIM.

US 3.3 Applications

For US 3.3 applications, the Preparing for Bulk eCTD Import job will look in the Sequence folder with the lowest sequence number first. To ensure a successful import, set the Application Code to the Application Number in the us-regional.xml with the lowest number.

Application Code Matching Warnings

If no matching Application Code is found, the application is skipped and the following message appears in the log: "WARNING: The Application located here: "<path to application>" failed to import: The Application Code(s) "<coma separated list of application codes from xml>" cannot be matched in the system, please create the Application and try again."

When there are multiple matching Application Codes, the system includes the Application Code and Folder path to the Application within the Job Messages for that Job with the following message: "WARNING: The Application located here: "<path to application>" failed to import: The Application Code(s) "<coma separated list of application codes from xml that matched multiple applications>" matched multiple Applications in the system."
Note: Canceling a Preparing for Bulk eCTD Import job will not cancel individual eCTD import jobs that have already been prepared and are in the queue.