Next RPS Ballot Delayed Until September 2011

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It has been a while since I have updated you on the RPS project. Back in September, I had expressed cautious optimism on being able to bring RPS to vote (ballot) in May 2011. We did not make the May 2011 ballot, thus the ballot is now delayed until September 2011.

We did not make the ballot, in my opinion, since we are still working on refining all of the requirements. We have two requirements left to be finalized; namely, being able to reuse studies and all of the components in two applications and support for the new European variation legislation.

Being able to reuse studies and all of the components in two applications will allow sponsors to create a study, define all of the components (e.g. protocol, study report body, synopsis, etc) in one application (e.g. investigational application) and refer to the study in your marketing application. This benefits sponsors since it allows them to synchronize content for a study in more than one application.

The new European variation allows a sponsor to create one sequence (e.g. a manufacturing change) and apply that sequence to many products. This will benefit sponsors since they will no longer have to track multiple products for one manufacturing change.

To create the publication before the ballot opens, HL7 headquarters needs content over a month in advance. The ballot period is one month: see the following sample HL7 publishing schedule.

  • 5 weeks before publication: Initial Content Due – Submissions should be as complete as possible, particularly for a first-time ballot. In all cases, the submission should indicate the topics and artifacts that will be included in the forthcoming ballot. If possible, complete preview material should be submitted so that it can be made available on the Ballot Preview site by the end of this week.
  • 4 weeks before publication: Ballot Preview – All content to be included in the preview site is due. The Ballot Preview site (based on the previous ballot) will go live.
  • 3 weeks before publication: Reconciliation, Complete & Supporting Content Deadlines – All previous ballot reconciliations for normative ballots must be completed and appropriately captured on the ballot website.
  • 2 weeks before publication: Final Content Due – All final corrective changes to existing content are required.
  • 1 week before publication: Provisional Ballot Opening – This is the earliest date that the ballot site can open and be announced to the membership. In any event, the ballot must open before the end of this week.

I feel confident that we will make the September 2011 ballot. Stay tuned for more information.

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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