eCTD as a Required Format for FDA Submissions

eCTD Pyramid

The eCTD Pyramid

The electronic Common Technical Document (eCTD) is due to become a requirement in the immediate future (immediate in the FDA sense of the word). By 2017 FDA will have made the transition from paper to electronic submissions complete. Hopefully, the transition of most types of recordkeeping will also make the transition to electronic format. After the initial investment, this should cut the time and cost of bringing new health products to market. What do you need to know about eCTD? That’s the topic of Kathie Clark’s Guest Commentary.

Five Steps to Become eCTD Ready, by Kathie Clark

In FDA’s PDUFA V Commitment Letter 8-31-2011, the agency announced their intention of issuing draft guidance for required electronic submissions in eCTD format by December 31, 2012, with final guidance no more than 12 months after the close of the public comment period. Twenty-four months after publication of the final guidance, electronic submissions will be required for all new NDA and BLA submissions (originals, supplements and amendments) with a few specified exceptions.

Although many in industry were aware that the agency was preparing legislation to mandate eCTD, others have long been postponing moving to electronic submissions until FDA “pulled the trigger.” The good news is that FDA’s timeline still allows plenty of time for an orderly move to eCTD if plans are put in place now.

Here are some key steps to move to being eCTD-ready:


Get Educated on eCTD

1. Get educated. If you are fortunate enough to have one or more team members with real experience in eCTD from a former employer, consider whether they can lead education and process transformation efforts needed to be eCTD-ready. However, be realistic about whether their day jobs allow for these activities. If you need help, consider sending employees for training – or better yet, bring in a knowledgeable consultant to educate your team and help them establish a plan for eCTD readiness. If you have more than a few employees who need training, it’s probably a more cost-effective approach, plus education can be tailored to the context of your submissions, taking into account what types of drugs or biologics you produce, whether generics are involved, which authorities you submit to, whether you will outsource or produce submissions in-house, and many other factors.

2. Understand and act on steps needed to make your source documents eCTD-ready. If you have been submitting paper eCTDs, you may not have been concerned about the quality or granularity of your PDF source documents. For more detail, see my recent article Five key steps for e-submission ready documents to avoid pre-submission rework on the Applied Clinical Trials website. It’s important to understand that you must produce submission-ready documents even if you plan to outsource submission preparation.


The Decision to Outsource

3. Decide if you will publish submissions yourself or outsource to a partner. If you plan to outsource, you will need to develop a plan and questionnaire for selecting the most appropriate partner based on competence, cost, specific services offered, service level agreements, and other factors. If you will be publishing in-house, you will need to select, purchase and deploy a publishing tool and ensure that your employees are trained on it and have developed appropriate procedures. Don’t forget submission review – you may want to acquire the validation and review tools used by the agency or agencies you submit to.

4. Develop an overall timeline. Where do the above activities fall? What other factors, such as key submissions, influence the cut-over date that you plan?

5. Understand the logistics of the actual transition. The eCTD Summit blog entry Transitioning from Paper to eCTD at the eCTD Summit provides an excellent overview, with some good follow-up info from FDA correspondence found at the ask-cato blog. It’s best to treat this activity as a formal project, with a project manager, budget, schedule and milestones, and “definition of done” – what does eCTD-ready mean to you and how will you know when you have achieved it?

By planning now, you can achieve compliance in the specified timeframe while also moving to reap the benefits of implementing eCTD.

(eCTD pyramid graphic- Wikipedia)

By Kathie Clark

Kathie’s Website: NextDocs

Ask Cato Blog

The eCTD Summit

Time is running out to comment on the Draft FDA Guidance on Risk-Based Monitoring!
Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

How to comment to FDA: Here is a two-slide powerpoint presentation on how to comment on the draft guidance document courtesy of CDRH BIMO. Thanks!

Location of Monitoring guidance FR


clinical trials FDA monitoring guidanceThere have been some great comments on the GxP Perspectives LinkedIn group on the Draft FDA Risk-Based Monitoring guidance document and on protocol deviations. There is also a new logo for your viewing pleasure. I invite everyone to join the GxP Perspectives LinkedIn Group and join the discussion.

GxP Perspectives LinkedIn Group

GxP Perspectives on twitter: @GxPPerspectives

And two GCP resources on twitter: @GCPworks and @rebarinter

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On The Blogroll: Rebar Interactive (their twitter account is above) has an excellent blog. They are a digital media company with a focus on the clinical trials industry. Please check out their post on:
Patient Recruitment: Think That You Might Be Wrong,”
if for nothing else than the photo. A great blog post by Rahlyn.
Please comment with your views on eCTD

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