Module 3 Project Management

Module 3 is usually the most complicated part of an eCTD submission for Regulatory Operations. It contains a lot of complex documents, and small companies that may have a medical writing group usually don't have a similar group for CMC documents. Finalizing CMC documents is often very challenging due to the nature of the documents themselves and the number of parties who have to sign off. Regulatory Operations groups can take a few steps to increase the predictability of this effort, as outlined below. First, recognize that module 3 is probably the most complicated section of any eCTD submission to publish, and has the least upstream resources available to help with formatting. It's important to start with a set of templates that can assist authors with basic formatting steps that will improve the quality of PDF renditions.

Second, build trust with the authors. They're mostly scientists whose day jobs don't involve writing submissions. They tend to view document formatting as both unimportant and someone else's responsibility. Help them understand what you need and how you'll help them. And follow through. Pay special attention to tables they want to paste into the templates.

Third, CMC authors tend to be very process-oriented, but that doesn't mean they've mapped out the process for reviewing their documents. Help them figure this out. Start by creating an inventory of all the documents that go in m3, and identify responsible authors for each one. The biggest challenge is uncovering all the groups that will have to sign off on the documents. This may include development partners, contract manufacturing organizations (CMOs), and Quality groups. Identify contacts with each group, and any special requirements they may have. Figure out where in the process data verification will be done. Map out the process so everyone is on the same page.

Finally, recognize that some of the documents will have to be written before all the data is in. This presents an interesting challenge. The people who are working closely with the data and the documents will probably develop of level of comfort with finalizing the document and then dropping in the data. They may view the document as "done". Other groups that are farther away from the process, like CMOs, development partners, and QA often insist on conducting their final review after the data is dropped in. Make sure to get these types of assumptions ironed out early in the process. Try to plan final reviews around groups of documents, such as all of 3.2.s.2, so that reviewers can see the information in context.

Help CMC authors in whatever ways you can. RegOps success depends on them. At the same time, make sure that authors understand that their job is not complete until they hand off final documents to RegOps, and that once they do, they can't make any more changes. Help the authors with formatting early and often, so they learn what's involved and how it can improve the presentation of their data. If possible, show the authors the current view of m3 in another eCTD submission so they can see what the end product will look like and how it will benefit them. Module 3 will always be complex, so RegOps needs to be proactive to ensure a successful submission.