Agile For Regulatory Submissions Glossary

Agile for Regulatory Submissions

Glossary of Terms

Sprint – In the context of Agile for Regulatory Submissions, a time interval of one month or less during which one or more “done” submission deliverables are approved and ready to be submitted

Definition of “Done” – A shared understanding among members of the Agile Team of what it means for work to be complete. Often times the definition of “done” is represented by a checklist.  

Daily Stand Up Meetings – A daily, 15-minute meeting attended by all members of the Agile Team to synchronize activities and create a plan for the next 24 hours by inspecting what is forecast for that time period and what was accomplished in the previous 24 hours. 

Sprint Review – A team meeting held at the end of a Sprint to inspect the Submission Increment and review the Submission Backlog, Submission Tracker and Issue Log to determine the status of the submission. 
Sprint Retrospective – An opportunity for the Agile Team to analyze its performance and create a plan for improvements to be implemented during the next Sprint. This meeting occurs after the Sprint Review and prior to the next Sprint Planning session. 
Submission Increment – One or more submission deliverables defined as “done” that is ready to be submitted to the Agency without further work
Sprint Goal – An objective set for the Sprint that can be met. A goal might be a complete study or a focus on certain types of documents. The Sprint Goal is created during the Sprint Planning meeting. 
Submission Owner – Responsible for having a vision of the submission deliverables and conveying that vision to the Publishing Team and reviewers. 
Publishing Team – Consists of professionals who incrementally deliver submissions defined as “done” at the end of each Sprint. 
Submission Coordinator – Responsible for the team’s comprehension and enactment of the Agile for Regulatory Submission methodology. The Submission Coordinator makes certain that the team adheres to Agile Theory, practices and rules. 
Submission Backlog – Set of documents entered in the Submission Tracker that’s selected for the Sprint. 
Submission Tracker – A list of every document that will be submitted to an Agency
Issue Log – Issues identified during a Sprint that must be resolved