Import eCTD Applications

When you import an eCTD application you can import the entire eCTD, a series of eCTD sequences. The eCTD sequences are imported into an existing application with the required views.

The following files, at a minimum, are required to import an eCTD:

  • the index.xml file, in a folder named based on the sequence number
  • the regional XML in the M1 folder
  • all of the necessary DTD files

For example:

0000
   index.xml      
   m1             
         us-regional.xml
   util
         dtd
               <DTD files>             
         stylesheet
               <Stylesheet files>
              

Content files are not required for eCTD import. If you only have an index.xml file, you can substitute placeholder files (with Leafs removed) for the regional.xml and util folders from another sequence. During the import, if content files are found to be missing they not be referenced in the assembly: only leafs will be created. To ignore existing content files during an eCTD import, use the Import Leaf Files Only option.

The eCTD importer sets the assembly status for the first sequence in an application to In Draft instead of Approved.

When you import the eCTD application, you can create new sequences that are based on the existing lifecycles either to continue these lifecycles or for archival purposes. Any imported sequences must be in the correct file/folder format.

Each sequence folder is imported as a separate sequence. The location of these folders must be in a mapped file system repository. All files that are referenced by the eCTD XML leaf elements become assigned files underneath each leaf, pointing to this repository for content. The entire eCTD XML is imported as assembly metadata, including: leaf IDs, modified files, and envelope information.

You can import and add to the same application lifecycle more than once. In this way you can import sequences 0000 and 0001, and after you have added sequences 0002 through 0005 to the folder you can import again. The subsequent eCTD Import will process only the newly added sequences.

When performing an import of an existing eCTD, the import progress is reported in the server.log file. The Job Request Details also show messages about each sequence that is imported. The administrator can monitor the server log to follow the overall progress of the import and see more detailed messages, such as timestamps and Oracle information.

Although other repositories may be available in the eCTD XML import utility, only file systems, OpenText Content Server, and Documentum repositories are currently supported.

Note: To import China assemblies, verify that the following assembly templates exist in the system:
  • CN eCTD Module 1 v.1.0.xml
  • CN eCTD ICH Module 2.5 v.3.2.xml
  • CN Clinical Study Report (VV5-0).xml
  • CN Nonclinical Study Report (SEND Dataset).xml
  • CN Nonclinical Study Report.xml
To import EAEU assemblies, verify that the following assembly template exists in the system:
  • EAEU Template v1.0.xml
To import GCC assemblies, verify that the following assembly templates exist in the system:
  • GCC eCTD Module 1 v1.5 - GCC.xml
  • GCC eCTD Module 1 v1.5 - NP.xml