The Placeholder Debate: Why Teams Love (And Hate) This TMF Tool

By Suzanne Turner, ICE Consulting, LLC

Placeholders can spark strong opinions in the trial master file (TMF) world. Some teams rely on them heavily, while others avoid them altogether. And for those newer to electronic TMFs — or even experienced professionals who haven’t had to think much about placeholders — they can feel like a bit of a mystery.

This article takes a closer look at what placeholders are, how they work, and why they continue to be a source of both value and frustration. If your team is weighing whether or not to use them — or just wants to better understand the trade-offs — this is for you.

What Exactly Is a Placeholder?

A placeholder is simply an empty slot within an eTMF platform that shows a record is expected and where it will be filed once it has been collected and uploaded. Think of it like a reserved parking spot. It’s there to give visibility into what’s missing and help ensure the TMF stays aligned with what’s expected based on the protocol, SOPs, or your essential document list (EDL). In fact, an EDL is essentially a collection of placeholders — it defines what “should” be there, whether or not the documents have been received yet.

Placeholders can take different forms depending on the system. Some are automatically generated from the EDL, while others are added manually by the team. In some platforms, they’re visible directly in the document structure; in others, they only appear in reporting tools or dashboards. Regardless of how they’re surfaced, the goal is the same: to track TMF completeness and provide a structured way to monitor what still needs to be collected.

If you haven’t worked in a system that uses placeholders, they might feel unfamiliar at first. But the concept is straightforward — they’re there to support proactive TMF management, rather than reactive cleanup. When used intentionally, they help teams plan ahead and stay on top of document collection throughout the life of a study.

What Makes Placeholders Appealing

When implemented effectively, placeholders can add real value to TMF management. They help track which records are expected and support alignment with the EDL, serving as a visual cue that something should exist at a specific point in the TMF. They also contribute to the overall structure and organization of the TMF by clearly identifying gaps, often through dashboards or reports. For example, a dashboard might flag that a monitoring visit report is expected for a given site, allowing the team to follow up before closeout. During completeness reviews or quality control checks, placeholders can serve as a helpful reference by indicating which documents are still pending, even if they haven’t yet been collected or finalized.

Given these benefits, it’s easy to see why placeholders were introduced and have become widely used across the industry. On the surface, they offer a simple, structured way to visualize what’s missing and ensure teams stay aligned. But as useful as they can be, real-world experience has shown that using placeholders effectively isn’t always as straightforward as it seems. Not all systems handle them the same way, and without the right processes in place, they can quickly go from helpful to misleading.

The Risks And Realities Of Placeholders

Placeholders are only as effective as the processes and people supporting them. Without intentional oversight, they can quickly create confusion instead of clarity.

One common issue is that a document may be uploaded to the system but not directly into the placeholder itself, leaving the placeholder in place and giving the impression that the document is still missing. This disconnect can be misleading during reviews or metrics reporting. It’s also common for placeholders created early in the study to remain in the system long after the document is no longer needed. Without regular upkeep, placeholders can quickly become outdated and no longer reflect the current expectations for the study.

In some cases, placeholders don’t offer enough detail to be truly helpful. For example, a placeholder may indicate that a curriculum vitae (CV) is missing but not specify whose. Without that level of clarity, teams may find themselves spending extra time investigating whether John Smith’s CV, or Maria Lopez’s, is still outstanding. Multiply that across dozens of documents, and it becomes a real tracking challenge.

System limitations can add another layer of complexity. Some platforms are set to automatically create or clear placeholders under certain conditions — like when a document is uploaded — but the logic isn’t always aligned with real-world needs. If four CVs are expected and only one is uploaded, the system might either clear the placeholder entirely or create just one new one, leaving the remaining three untracked. On the flip side, it might generate a new placeholder when no additional document is expected — say, for a finalized protocol that doesn’t require a new version. Either way, inaccurate placeholders can lead to misleading completeness metrics and missed follow-up.

Maintaining accurate placeholders requires time and attention. In small studies, manual oversight may be manageable. But in larger trials — especially those involving multiple countries, sites, and vendors — keeping placeholders current can easily become a full-time responsibility. Most teams already have competing priorities, and relying on everyone to update placeholders “when they have a chance” isn’t realistic. A better approach is to assign ownership and establish a clear, documented process to ensure placeholders are created, updated, and retired intentionally.

Ultimately, placeholders can be a helpful tool, but they aren’t something teams can rely on 100%. Without proper governance, they can give a false sense of TMF health and lead to downstream issues during reconciliation, QC, or inspections.

Should Your Organization Use Them?

As with many decisions in TMF management, there’s no universal right or wrong answer when it comes to using placeholders. Some teams find them invaluable. Others avoid them altogether. And many land somewhere in between, seeing their potential but also recognizing their limitations.

The truth is, placeholders can be incredibly useful if they’re supported by a clear process, dedicated oversight, and a good understanding of how they work within your specific system. But they aren’t something you can rely on alone. A risk-based approach — encouraged in current regulatory guidance — means teams must consider the level of oversight and control needed for the study, including how document expectations are tracked and maintained.

Before deciding whether to use placeholders, it’s important to assess a few key factors:

• Is your team familiar with your eTMF system and trained on how placeholders behave within it?
• Does your platform support placeholders in a way that’s flexible and manageable?
• Do you have the resources to review and maintain them consistently across the study life cycle?
• Are you already working from a detailed EDL that defines what documents should be expected?

Without those pieces in place, placeholders can create more confusion than clarity. And even with them, they’re only one part of the bigger picture. For many teams, the challenge isn’t whether placeholders are good or bad, it’s navigating how to use them intentionally, knowing they’re not foolproof. That tension is what keeps the placeholder debate alive: a mix of appreciation and frustration that’s unlikely to go away anytime soon.

A Note On System Trends

It’s also worth noting that not every eTMF system includes placeholders — and among those that do, some are starting to rethink how (or even if) they should be used. While we’re not naming vendors here, it’s something to keep in mind, especially if you’re evaluating new platforms or considering a configuration change. Some systems have removed placeholders entirely or simplified how they function, often in response to the amount of manual effort required to maintain them accurately. Others are exploring ways to make placeholders more efficient, looking at how automation or AI could reduce the burden and improve usability.

That said, placeholders aren’t strictly necessary for effective TMF oversight. What matters more is having a clear, consistent process in place to track expected documents, whether that’s through placeholders, structured dashboards, or other system-supported methods. Technology should support your process, not dictate it.

Final Thoughts

Placeholders are one of those TMF tools that tend to come with strong opinions, with good reason. When used with intention and supported by a clear process, they can help teams stay organized and keep the TMF on track. But without that foundation, they can quickly add more confusion than clarity.

There’s no single “right” answer when it comes to using placeholders. What matters most is understanding their strengths and limitations and deciding how they fit into your overall TMF strategy. Like so many things in clinical trials, success depends not just on the tool but on the people, processes, and systems around it.

About The Author:

Suzanne Turner is the founder of ICE Consulting, LLC, where she partners with small to mid-size sponsors to support Trial Master File (TMF) management, vendor oversight, and inspection readiness. With more than 12 years of experience spanning CROs, sponsors, and consulting roles, she offers practical, risk-based guidance rooted in real-world TMF challenges.

Suzanne is a volunteer with the CDISC TMF team and a passionate advocate for better TMF processes — from strategy and implementation to remediation and training. She also hosts Heart of the Trial, a podcast that highlights the people behind clinical research and their personal “why.”

Connect with Suzanne on LinkedIn or visit her website to learn more.