The Benefits of Tracking Sheets for Regulatory Submission

It might seem counterintuitive, but spending time detailing your submission content at the start of a business process services (BPS) engagement can save you time – and complications – further down the line. The clearest, most methodical way to do this is by using submission content tracking sheets.

By Anja Wesphal and Usha Sharp, Regulatory Engagement Management, Life Sciences

Providing a well-prepared submission content tracking sheet along with the submission files will give the publishing team a clear overview of the required tasks and workload involved, enabling them to plan what resources are required. Perhaps most importantly, it will allow the team to complete the project correctly from the outset.

What Constitutes a Good Tracking Sheet?

At a minimum, the tracking sheet should include a list of files relevant to the specific submission. Ideally, it should include the actual output file names and file titles. For example, under the clinical summary section for Module 2, the output file name for the Clinical Efficacy Summary would be captured as <summary-clin-efficacy-VAR> and the document title would be captured as <Summary of Clinical Efficacy – [Indication]>. The variable part would contain the indication and can be defined per the client’s specific naming convention.

When managing the life cycle of a submission, it’s important to make clear whether the information is new, replaces existing information, should be deleted or is appended. Including the sequence number helps to avoid confusion about exactly where the amended information belongs. Without this information, it’s difficult to determine exactly which information is being replaced, and any mistake will result in rework or a chaotic application. The inclusion of all this information also provides an audit trail for the company.

Another crucial element in the tracking sheet is determining the country or countries receiving the submission, particularly in Europe, since not all submissions are submitted to the European Medicines Agency. For example, a National Procedure submission would only be submitted to the relevant country, and a Mutual Recognition Procedure submission might only be submitted to 10 EU countries.

Any tracking sheet should include the metadata for the regional envelope of the submission, since this information will encompass administrative details and the type of submission involved. In addition, values need to be provided for the ICH metadata such as Indication, Drug Substance and Drug Product details in order to build the correct folder structure.

Including an issue log as a separate tab in your tracking sheet allows for clearer communication and addressing any questions and updates with regards to the specific submission as you don’t need to switch between multiple files but have all information in one place

Having the metadata, file information and also a status of what has been already processed per file clearly detailed in a tracking sheet means if the relevant team member is away, for example, that information is not lost or buried in an email.

Tracking sheets can be stored on a data management system, where relevant, which allows the sheet to be automatically version controlled. Alternatively, a file server allows the tracking sheet to be shared with multiple team members working in parallel. However, it’s important to establish a business process to avoid information being accidentally overwritten, for example, by deleting rows.

What Do You Gain from Using a Tracking Sheet?

When using a comprehensive tracking sheet, companies will realize many benefits, including:

  • Fewer queries about the placement of files. When companies send files to their BPS partner, one challenge has been knowing where in the structure those files need to be placed. With a tracking sheet, the publisher automatically knows where to place the files, saving time for both the client and the publisher, and removing the need for rework.
  • Fewer issues during the review. If the client provides the file names and titles as they expect them to appear, the publisher can ensure this is handled right first time.
  • Easier management of complex, ongoing submissions. An initial eCTD submission is large and complicated, with multiple documents across the five modules. Typically, the files for Module 4 are ready first, followed by Module 5 and Module 3, and finally Module 2 and Module 1. A tracking sheet allows the publisher to add files as they arrive and know exactly where to place them.
  • Provide clarity on the number of files. Without a tracking sheet, it’s difficult for the publisher to know when all documents and files have been received, and if your publisher doesn’t know what’s missing they can’t act quickly on your behalf. A tracking sheet makes it clear where files are missing, making follow up at the end of the process easier.
  • Accurate submission processing and faster turnaround times.

There are many moving parts in handling a submission, and toward the end of the submission process, you are so busy and overburdened that inevitably things may get overlooked. Furthermore, you may not have time to deal with multiple questions from your BPS partner. Having a tracking sheet resolves those issues for both simple and complex projects.

Finding a way to work with your BPS partner in a seamless and organized way, which a tracking sheet enables, not only alleviates stress but ensures the highest quality outcomes.

View our recent webinar, “Business Process Services – A Strategic Enabler for High Quality Regulatory Submissions.”


  1. This site is very good, it helped me a lot.


  2. Congrats for this post, thanks


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