Q&A No. 36   updated May 2007
1	Ensure there is an ICH backbone file named index.xml in the sequence folder
2	Ensure ICH published checksum(s) of eCTD DTD is the same as checksum of eCTD DTD in ‘util/dtd’ folder
3	Ensure the index.xml is validated against the corresponding eCTD DTD version in the ‘util/dtd’ folder
4	Ensure the eCTD index.xml is validated for logical and correct attribute content as defined in the ICH eCTD specification as follows:
	- If the value of the operation attribute is new, then the modified-file attribute value is empty or not provided
	- If the value of the operation attribute is append, replace or delete, then the modified-file attribute will have a valid value
	- If the operation is new, append or replace, then the attribute xlink:href will have a valid value
	- Verify that the ID attribute value starts with a letter or underscore character
5	Ensure there is a xx-regional.xml[1] in the appropriate folder
6	Ensure regionally published checksum(s) of the DTD, Schema, and related files are the same as checksums of the corresponding files in the ‘util/dtd’ folder.
7	Ensure the regional index files are validated against the corresponding regional DTD, Schema, and related files (e.g.,  mod files) in the ‘util/dtd’ folder.
8	If using regionally required instance files (e.g., STF), ensure regionally published checksum(s) of the DTD, Schema, and related files are the same as checksums of the corresponding files in the ‘util/dtd’ folder.
9	If using regionally required instance files (e.g., STF), ensure the instance files are validated against the corresponding regional DTD, Schema, and related files in the ‘util/dtd’ folder.
10	Ensure the regional xml file (s) is validated for correct XML syntax and correct attribute content (consult regional guidance)
11	Ensure the checksum for every file is equal to the associated checksum stated in the relevant backbone (i.e., index.xml, xx-regional.xml)
12	Ensure all the files identified by an xlink:href reference exist. Regional authorities must be consulted as to whether the target of an xlink:href can exist outside the sequence in which the referencing leaf appears.
13	Ensure there are no unreferenced files in folders m1 through m5 (including subfolders other than ‘util’ subfolders)
14	Ensure the appropriate format is used for the modified file attribute in relation to the DTD being referenced.  (Specification 3.0 vs. Specification 3.2)
15	Ensure that all file and folder naming conventions (length limits and allowable characters) comply with Appendix 6 of the eCTD Specification (Note:  Folder and file names in the eCTD Specification are highly recommended, not mandatory (see Q&A No. 15))
16	Ensure that all the lowest level heading elements included in the submission contain at least one leaf
17	Ensure no PDF files are larger than 100 megabytes
18	Ensure that sequence numbers have 4 digits (i.e., numbers between 0000 and 9999)
19	Ensure that the sequence folder name matches the sequence number in xx-regional.xml (not applicable in Japan)
20	Ensure that leaf or node extension Title attribute is not empty. The only exception is a leaf element with the operation attribute value "delete" where the Title may be empty.
21	Ensure no files have file level security or password protection enabled
22	Ensure that the PDF Links and bookmarks are relative
23	Ensure that PDF files have been optimized for fast Web delivery
	[1] Where xx represents the ICH region designator: eu for European Union; jp for Japan; us for United States regions