Two-Way Communications Exchange of information during the Review process between Regulatory Authority and Sponsor

Communication  The process by which meanings are exchanged  Elements Sender – Initiator of Information Receiver - Receiver of Information Message - Has many forms, focus will be on electronic information only. The best form to use depends on many variables including importance, urgency, and goal of the communication

Objectives  How to communicate or Form of communication  Define sender and receiver  Storage – Where, how and who

How to Communicate  Transmission is out of scope Must be secure Internet  Gateway   Web  Other

Define Sender/Receiver  Both applicant and regulatory authority will be both sender and receiver  Is there is a need to maintain communication thread?

Discussions  Will we let agency make changes to submission content?  Suggestion: We can have another (message.xml) that is specific to regulatory authority but resides within the submission Tightly linked to submission backbone Elements and Metadata to be defined

Possible communication  Ability to allow the regulatory authority to associate a file to an submission group (reviewable unit) and zero to many submissions. This document should be one of many types (e.g., an approval letter).  Ability to allow the regulatory authority to comments/questions to specific files or logical documents.  Ability to allow the regulatory authority to update status of submission (on hold, approved, clock status).  Ability to allow the regulatory authority to update the submission type and submission group identifier.  There is a need to keep a communication thread. At minimum, a correspondence needs to be linked either to the original submission or a supplement. It should be possible for an applicant to respond and link to one or more communications.  Acknowledgments of receipt

Review Cycle  Applicant Creates message Assigns ACTION Sends message  Regulatory Authority Receives message Attaches an ACTION Sends message  How?

Should Accommodate Current Initial Message 0000 Initial Message 0000 Change Requested Change Requested Response 0001 Response 0001

Should Accommodate Future Initial 0000 Initial 0000 Message 0000-R Message 0000-R Message 0001 Message 0001 Message is placed within the submission under appropriate document/entity

Example 1