eCTD Publishing Best Practices

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Editor’s Note: Evan Richardson, now Director, Regulatory Services at GlobalSubmit, wrote this article while working at Cato Research. 

People seeking advice on eCTD publishing best practices usually fall into one of two groups:

  1. Sponsors who are new to eCTD, medical writers or project managers
  2. eCTD publishers

The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions. So, in thinking about our publishing processes at Cato Research, I’ve identified a few of the keys to our success that could be applicable to any organization.

Partner with your Document Authors

The most frustrating issues we face as publishers aren’t complicated software problems, ESG issues or confusing guidances. They usually involve content-related problems in the documents we’re given. Common examples include poorly worded hyperlink references, lack of any bookmarks and internal hyperlinks or the dreaded revisions to “final” documents. At best, these types of problems can be irritating to resolve, and at worst, they can result in significant delays.

When you discover such an issue, don’t just mutter under your breath. I encourage you to pick up the phone or walk down the hall and have a friendly, one-on-one chat with the author about the issue. Almost always, I’ve found that the author wasn’t just being lazy; instead, no one had ever told the author that there was a better way to do things. By developing a “we’re all in this together” atmosphere with your authors, you will receive better, eCTD-ready documents. Once they see you as a friendly face that’s willing to help, they’ll also feel more comfortable proactively approaching you for best practices advice. Improving communication between your two groups – groups that may not typically mingle in many companies – will make everyone’s life easier and improve the quality of your submissions.

Use an eCTD Validation Tool

There are so many ways that you can unintentionally introduce errors into an eCTD submission, whether it’s a broken link that might slow down an FDA reviewer, or a more serious oversight that can cause the FDA to reject your submission. For this reason, it is essential that you are using a validation tool to help avoid sending in a submission that might contain embarrassing mistakes.

At Cato Research, we use two validation tools with overlapping functionality to ensure the highest level of quality. As the first line of defense, we use the validation tool that’s built into our eCTD publishing software. It does a great job of identifying things like broken or invalid hyperlinks, but it doesn’t necessarily check for all of the important things the FDA checks.

For our second line of defense, we use GlobalSubmit VALIDATE. It’s the same tool that FDA uses to validate submissions upon receipt, so I know that if my submission passes its test, my submission will be accepted by FDA. The validation reports provide you with the errors discovered as well as helpful information on how to resolve them. Also, the latest version automates several PDF document checks that used to be part of our manual quality control process.

Regardless of what validation tool you’re using, the take home message is to make sure that you are actually using a validation tool, and ideally, more than one.

Be Aware of the ESG Deadline

If a submission is received via the ESG after 4:30 PM ET, the official date of receipt for the submission is the next government business day. The important thing to note here is the word “received.” A common misconception is that we just need to begin the upload by 4:30 PM, when in reality, the upload must be completed (you’ve received the “Done” message) by 4:30 PM.

For smaller, routine submissions, I plan to start the upload no later than 4:00 PM. If it’s a day with a likelihood of a high submissions volume (the last day of the quarter, for example), I’ll plan to begin uploads even earlier to ensure they get through the system in time.

For larger submissions such as an IND, NDA or a major supplement, I’ll actually start the upload just after 4:30 PM on the day before the official submission date. The FDA encourages this practice, as it allows your submission to be received, processed and delivered overnight, when the traffic through the ESG is minimal. This also provides you with a measure of insurance against upload errors. Should there be any problems like a network failure that prevented the upload from completing overnight, you can restart the upload again first thing in the morning and still have enough time for it to complete before the deadline.

For time-sensitive submissions, avoid uploading a submission on a federal holiday. Through correspondence with the CDER’s electronic submissions staff, I’ve learned that if a submission is uploaded at any time on a federal holiday, the official date of receipt for the submission is the next government business day.

Develop a Workflow and Stick With It

eCTD submissions have exacting standards, and so it’s no surprise that most publishers are very detail-oriented people. Despite that, it can still be pretty easy to overlook something important, especially when you’re in a time crunch. Many organizations have developed exhaustive forms or checklists to help their publishers avoid mistakes. I’m not a fan of filling out forms, but I do agree with the principle behind them in this case.

It is critical for you to develop a workflow for the preparation of your eCTD submissions and to religiously follow it for every submission. Just as the Army trains a soldier until his assigned tasks are second nature, your workflow will help you to compile a submission the same way and in the same order every time, improving your efficiency and minimizing the chances for errors.

Stay Current

Since our area of expertise is technology-driven, it often changes at a faster pace than the rest of the industry and it’s more important than ever to stay up-to-date. Attending one of the annual industry conferences is always a great way to learn new things and share tips with your colleagues, and I encourage you to attend these if your budget allows. Fortunately, technology also makes it easy to stay current, even in an era of reduced training budgets.

If you’re not on Twitter yet, you’re missing out on a great resource. Many knowledgeable regulatory publishers are active on Twitter, giving you the opportunity to receive regular (and free) updates and advice just by “following” them. Blogs are another great way to get current information (If you’re reading this, you probably already knew that!). Keep on an eye on the eCTD-related blog posts you see discussed on Twitter for ideas on what you should be reading on a regular basis. Also, don’t overlook the free webinars and presentations that many organizations offer. It is true that these often include a soft pitch for that organization’s products or services, but it is also true that they are a great source of information at a great price!

These are just a few of the ideas that we’ve implemented in our organization. Because every organization is different, there is no “one size fits all” approach; however, I hope that the general concepts I’ve presented can be of some use to you. I welcome comments from you on the best practices for eCTD publishing that you use in your organization.

Author: Evan Richardson

Evan Richardson brings 10 years of experience in regulatory affairs and operations to GlobalSubmit. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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