Twoway communication Jason Rock Jason RockGlobal Submit org

Two-way communication Jason Rock Jason. Rock@Global. Submit. org 856. 854. 4455 x 105

Storyboards • • • C 1. Associate a regulatory action on a submission C 2. Associate a regulatory action on multiple submissions C 3. Ask questions to a particular file C 4. Ask questions to a particular logical document C 5. Responding to a question for a regulatory authority C 6. Ask questions to a particular application/submission unit C 7. Acknowledgment of receipt of message C 8. Changing an amendment to a new supplement/variation C 9. Separate a supplement to more than one submission C 10. Communication about documentation submitted outside of the Standard C 11. Question on non-application specific items (out of scope)

Roles • Regulatory authority • Applicant

Business Needs • Regulatory authority updates status of a submission(s) (approved, not approvable, etc. ) – Storyboard C 1, C 2 • Regulatory authority ask a question about an application, submission unit, logical document (defined by keyword groups), context of use (files used in a submission) – Storyboard C 3, C 4 , C 5, C 6, C 9, C 10 • Applicant and regulatory authority responds to a communication (creating a communication thread) – Storyboard C 5 • Applicant and regulatory authority acknowledges receipt of a submission unit message or a communication message – Storyboard C 7 • Applicant and regulatory authority updates relationship of a submission unit to a submission and/or a submission to an application – Storyboard C 8

Activity Diagram

Relationships / Cardinality • One communication can be associated with one or many application, submission unit, logical document (defined by keyword groups), context of Use (files used in a submission) • One communication can only be associated to either zero or one other communication (to maintain thread) • Submission unit can be associated with one or many submissions • Submission can be associated with only one application

Class Diagram – Communication Thread

Class Diagram – Submission Hierarchy