Published Output Specific Conditions

A submissionunit.xml file contains ICH and Regional sequence content that includes study data.

The submissionunit.xml file is created according to the ICH eCTD v4.0 XML schema. See:Submit eCTD 4.0 Publishing Request.

Depending on the controlled vocabularies selected in publishing settings, the object identifiers (OIDs) of applied versions are specified in the <receiver> section.

Each assembly leaf is published as onecontextOfUseelement along with the priorityNumber. The priorityNumber is populated in the Priority Number field of a leaf. If there is a change of the priority number value, the updateMode is applied.

Each contextOfUse has a code attribute populated. It is taken from the corresponding attribute of the parent folder for each particular leaf.

Each contextOfUse has statusCode populated. It is active for all the leafs and suspended for leafs with the Suspend operation.

A contextOfUse may have controlActProcess>> subject>>

submissionUnit>>component>>priorityNumber> contextOfUse>> replacementOf>>

relatedContextOfUse populated. It takes a value only if the corresponding leaf has Replace or Mreplace operation. The value is UUID value or values of the old replaced leaf(s). It is Modified Leaf field.

Each contextOfUse has derivedFrom>> documentReference. It is populated with UUID value of the

published document, not the documents under the leaf. It is not provided for the leafs with the Suspend operation.

Each contextOfUse has referencedBy>> keyword populated. It is taken from the parent folder of the corresponding leaf. In the cases where the SDKs are included, the keyword code and codesystem are

provided in the referencedBy>> keyword>> code section. If the keyword code is not present in controlActProcess >> subject >> submissionUnit>> componentOf1>> submission>> componentOf>> application>> referencedBy>> keywordDefinition>> value>> item, its

definition is provided here. There should be only one definition for each code within codesystem value. The keyword definition includes code, codesystem and value (the name of the keyword). If the value is changed, the updateMode is applied. controlActProcess >> subject >> submissionUnit >> componentOf1 >> sequenceNumber is populated with the sequence code value.

controlActProcess>> subject>> submissionUnit>>componentOf1>>submission>> componentOf>>application>> component >> document provides: — id - UUID of published document

— Title - title of the leaf. If the title is changed, the updateMode is applied.

— Text attributes - different values related to the text.

— Reference - the path to the output file.

— integrityCheck - checksum value for output document.

— All the SDKs are defined in controlActProcess >> subject >> submissionUnit>> componentOf1 >> submission >> componentOf >> application>> referencedBy >>

keywordDefinition section. The value from the agency-defined vocabulary is introduced as code@code and as codesystem for it is put as code@code. The SDK name is introduced as

value>>displayName@Value. The sender-defined code is introduced as value>>item@code. The application code system is introduced as value>>item@codesystem.

The folder structure is created according to assembly structure.

The values mapped to the DMS attributes use the attributes of the first document under a folder or a leaf to resolve the mappings.

A reference leaf element is published as a regular contextOfUse. The output document UUID of target reference leaf is used.

Depending on assembly type and the path entered, the file names are normalized to include only allowable characters. See: eCTD 4.0 Normalization Rules for more information. The other options can be as following: — If the filename is left blank for any leaf in the assembly, the system should use the leaf name, normalized per the rules above, adding the appropriate extension (.pdf, if Use Native File=No, extension of the assigned file if Use Native File = Yes) and include a message in the publishing log that no file name was provided so the leaf name was used.

— The checksum for the full submissionunit.xml file is calculated and included in a single-line text file named sha256.txt.txt and placed in the same location as the submissionunit.xml.

— If the assembly contains an empty folder, the system logs an error that the assembly is incomplete, including the section where the empty folder is. That portion of the XML includes an error code to indicate it is incomplete.

— If the assembly contains an element that does not have the expected parent information, so that the appropriate XML structure cannot be created, the system logs an error that the assembly is incomplete, including the section where the missing information is. That portion of the XML includes an error code to indicate it is incomplete.

— If the user cancels the publishing job while in progress, no xml file is generated. Any temporary files created during processing are removed.

Extension Types and Usage