About Agile for Regulatory Submissions

Core Principles

Editor’s Note: The core principles governing our Agile for Regulatory Submissions Methodology were adapted from the Principles behind the Agile Manifesto accessed at www.agilemanifesto.org/principles.html

  • Prioritize client satisfaction through early and continuous submission delivery
  • Welcome changing content, even late in the project. The agile process considers last-minute update to documents as a rule, not an exception.
  • Deliver functional sections frequently – every few weeks or every few months depending on the size of the submission. A shorter timescale is preferable.
  • Daily collaboration among authors, reviewers, and publishers throughout the project
  • Build submission projects around motivated individuals, giving them the environment and support they need. Trust them to get the job done.
  • Convey information face-to-face. This is the most efficient and effective method of communication to and within a publishing team.
  • Submission-ready documents with internal and external navigation aids are the primary measure of progress
  • Promote a sustainable publishing effort. The authors, publishers, and reviewers should be able to maintain a constant and consistent pace indefinitely
  • Continuous attention to technical excellence and good design enhances agility
  • Simplicity – the art of maximizing the amount of work not done – is essential
  • The best way to determine how to deliver high-quality, submission-ready documents emerges from self-organizing teams
  • At regular intervals, the publishing team reflects on how to become more effective, then fine tunes and adjusts its behavior accordingly

Education Series

GlobalSubmit has published a series of six (6) blog articles explaining the theories and practices behind the agile management methodology as it applies to regulatory submissions.

Our series is a derivative of an original work produced by Ken Schwaber and Jeff Sutherland called the Scrum Guide. The focus of the Scrum Guide was creating and sustaining software products. Our Agile for Regulatory Submissions series is focused on compiling submissions that will be sent to regulators for review.

The following links will become active as the articles are published on our eCTD Summit Blog.

Part I – How We Moved to Agile for Regulatory Submissions and Why It Worked

Part II – The Agile Methodology and Regulatory Publishing

Part III – Agile Regulatory Publishing Team

Part IV – Managing Regulatory Publishing Projects Using Agile

Part V – Submission Tracker, Issue Log Key to Agile Regulatory Publishing

Part VI – Transparency Vital to Regulatory Publishing Projects


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