Provide COU Code System values and Controlled Vocabulary. Refer to Appendix E, row 10. The IG should reflect that Related COUs cannot refer to COU IDs within the same Submission Unit. If this occurs, the RPS message should fail validation. Refer to Appendix E, row 11. Specify that Status Code on the Submission element as required. The Submission Status code would default to Active, but would be set to Inactive if a regulatory activity is withdrawn. The IG should also include more detailed instructions to describe RPS message elements to be addressed when a Submission is withdrawn by the applicant. Refer to Appendix E, row 12. Clarify Applicant Holder is always required. Refer to Appendix E, row 13. Clarify the business scenarios that require use of Submission Group. Validation criteria should be used to mitigate invalid use of Submission Group. Refer to Appendix E, row 14. Further RPS WG Discussion Required There were three findings that require further discussions within the RPS WG to determine whether / how they should be addressed. IMDRF-004 evaluates management of Certificates that support multiple Applications. The use of Document Keywords to manage Certificate detail worked well. However it is unclear whether there is value in using the Related Application element to tie Applications together when they rely on the same Certificate. Refer to Appendix E, row 5. Some vendor samples used the TOC section number as part of the Document Title. Because the TOC section number is also a Context of Use controlled vocabulary value and a single document may be assigned to multiple Contexts of Use, the inclusion of section number in the document title may cause confusion. Further discussion is required to determine if the IG should prohibit use of TOC Section numbers in Document Titles. Refer to Appendix E, row 6. The RPS message allows a Language attribute on both Document Text and Document Title. The Text Language attribute is intended to denote the language of the document content. The Title Language attribute denotes the language of the document title. The current IG on requires inclusion of the Text Language attribute. This assumes the language used in a Document Title will always match the language used in the document content. Additional discussion within the RPS WG is required to validate this assumption. Refer to Appendix E, row 7.
Provide COU Code System values and Controlled Vocabulary. Refer to Appendix E, row 10. The IG should reflect that Related COUs cannot refer to COU IDs within the same Submission Unit. If this occurs, the RPS message should fail validation. Refer to Appendix E, row 11. Specify that Status Code on the Submission element as required. The Submission Status code would default to Active, but would be set to Inactive if a regulatory activity is withdrawn. The IG should also include more detailed instructions to describe RPS message elements to be addressed when a Submission is withdrawn by the applicant. Refer to Appendix E, row 12. Clarify Applicant Holder is always required. Refer to Appendix E, row 13. Clarify the business scenarios that require use of Submission Group. Validation criteria should be used to mitigate invalid use of Submission Group. Refer to Appendix E, row 14. Further RPS WG Discussion Required There were three findings that require further discussions within the RPS WG to determine whether / how they should be addressed. IMDRF-004 evaluates management of Certificates that support multiple Applications. The use of Document Keywords to manage Certificate detail worked well. However it is unclear whether there is value in using the Related Application element to tie Applications together when they rely on the same Certificate. Refer to Appendix E, row 5. Some vendor samples used the TOC section number as part of the Document Title. Because the TOC section number is also a Context of Use controlled vocabulary value and a single document may be assigned to multiple Contexts of Use, the inclusion of section number in the document title may cause confusion. Further discussion is required to determine if the IG should prohibit use of TOC Section numbers in Document Titles. Refer to Appendix E, row 6. The RPS message allows a Language attribute on both Document Text and Document Title. The Text Language attribute is intended to denote the language of the document content. The Title Language attribute denotes the language of the document title. The current IG on requires inclusion of the Text Language attribute. This assumes the language used in a Document Title will always match the language used in the document content. Additional discussion within the RPS WG is required to validate this assumption. Refer to Appendix E, row 7.