Transparency Vital to Regulatory Publishing Projects

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The following is the sixth and final post in GlobalSubmit’s Agile for Regulatory Submissions series. GlobalSubmit’s regulatory services team employs the Agile Methodology for submission projects. By instituting Agile principles, our team has been very successful in delivering high-quality submissions ahead of schedule while maintaining constant, clear lines of communication with sponsors. To date, 75% of the regulatory submission projects executed by GlobalSubmit have been completed ahead of schedule.

The content used in our Agile for Regulatory Submissions series is adapted from the original work of Ken Schwaber and Jeff Sutherland called the Scrum Guide under the Attribution Share-Alike license of Creative Commons. Our series, which differs from the original work in the industry it describes, end product of the Agile process and professionals involved in producing the end product, is available for license under the identical terms.

Agile relies on transparency. Decisions to optimize value and control risk are made based on the perceived state of the artifacts. To the extent that transparency is complete, these decisions have a sound basis. To the extent that the artifacts are incompletely transparent, these decisions can be flawed, value may diminish and risk may increase.

The Submission Coordinator must work with the Submission Owner, Publishing Team, and other involved parties to understand if the artifacts are completely transparent. There are practices for coping with incomplete transparency; the Submission Coordinator must help everyone apply the most appropriate practices in the absence of complete transparency. A Submission Coordinator can detect incomplete transparency by inspecting the artifacts, sensing patterns, listening closely to what is being said, and detecting differences between expected and real results.

The Submission Coordinator’s job is to work with the Agile Team and the organization to increase the transparency of the artifacts. This work usually involves learning, convincing, and change. Transparency doesn’t occur overnight, but is a path.

Definition of “Done”

Each stage of the regulatory publishing process, including the Submission Increment, should have a definition of “done.” Accordingly, if your process includes criteria for document formatting, document publishing, submission publishing and internal review, then there is a definition of “done” for each process, namely, document formatting, document publishing, submission publishing and internal review. Often times this definition is represented by a checklist. The checklist is not always filled out, but it is used as a reference.

Everyone must understand what “done” means at each stage of the process. Although this varies significantly per Agile Team, members must have a shared understanding of what it means for work to be complete, to ensure transparency. This is the definition of “done” for the Agile Team and is used to assess when work is complete on the Submission Increment.

The same definition of “done” guides the Publishing Team in knowing what can be published during a Sprint Planning session. The purpose of each Sprint is to deliver Submission Increments that adhere to the Agile Team’s current definition of “done.” Publishing Teams deliver a Submission Increment or a complete submission every Sprint. If the definition of “done” for a Submission Increment is part of the conventions, standards or guidelines of the publishing organization, all Agile Teams must follow it as a minimum. If “done” for a Submission Increment is not a convention followed by the publishing organization, the Publishing Team part of the larger Agile Team must define a definition of “Done” appropriate for the submission. If there are multiple Agile Teams working on the submission, the Publishing Teams on all of the Agile Teams must mutually define “done.”

As Agile Teams mature, it is expected that their definitions of “done” will expand to include more stringent criteria for higher quality.

©2015 GlobalSubmit. Offered for license under the Attribution Share-Alike license of Creative Commons, accessible at and also described in summary form at By utilizing this Agile for Regulatory Submissions content, you acknowledge and agree that you have read and agree to be bound by the terms of the Attribution Share-Alike license of Creative Commons.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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