ECTD Review

Missing documents and broken links are just a few problems that could derail your eCTD submission. To ensure submission success, every detail of your dossier must undergo review prior to delivery. You will need to determine the technical validity of your submission, confirm content locations, and verify that each bookmark and link points to its intended target.

While GlobalSubmit REVIEW™ seamlessly guides you through this process from the same vantage point as the Agency, we recommend brushing up on Best Practices. Here are a few things you should know:

1. Review & Clarify Current Guidance

As evidenced by a recent rash of updates by regional health authorities, regulations are not static entities – they are subject to change. Prior to your initial submission, you should understand current criteria and develop a practical approach for your organization to support each particular guidance. In addition to reviewing published guidance, agency presentations posted online are helpful. Reviewers for each regional authority often discuss informal best practices and suggestions for creating easily reviewable submissions.

2. Create a Review Checklist

Your review process should be thorough enough to inspire confidence, but simple enough for a number of users to easily repeat. Develop a checklist detailing your review process and assign responsibilities. File the checklist away and update with best practices.

3. Define Hyperlinking Practices

Incorrect hyperlinks and bookmarks are a major challenge when compiling electronic submissions. During the course of a submission, files are moved, deleted, or replaced. As a result, links are broken or point to out-of-date files. GlobalSubmit CROSSCHECK™ alleviates this issue by providing users an interface that displays the link source and destination documents side-by-side. The application produces complete error reports – a vast improvement from tediously checking each hyperlink. However you choose to review your submissions, always verify that links are active and accurate.

4. Create PDFs from Electronic Sources

Regulatory authorities prefer to receive PDFs generated from text documents, as opposed to scanned ones, whenever possible. The ability to search within a document and copy text is critical to Agency reviewers. Industry mandates will soon render scanning handwritten signatures obsolete. We recommend converting to electronic signature technology as soon as possible.

5. Always Use a Fillable 356h Form

The FDA has a strong preference for fillable forms. In fact, the inability to extract information from PDF forms (due to a sponsor not using a fillable form) is the most cited processing issue. That being said, submissions utilizing fillable forms will reach the reviewer more quickly.

6. Establish Healthy Communication with the Regulatory Authority

Poor communication between Agency and sponsor is often cited as the number one obstacle to a successful submission. GlobalSubmit REVIEW™ solves this asymmetry of information issue. First, the application features a vantage point identical to the one seen by the reviewers at the FDA. Secondly, innovations such as Link 2 Share facilitate the post-submission dialogue between sponsor and Agency.