DIY Clinical Trial Monitoring Tracking Using Excel (if you can't afford CTMS)

In clinical research monitoring is absolutely necessary to ensure patient safety, data integrity, and regulatory compliance, but tracking the trial individual monitoring activities can be a difficult task. Enter the Clinical Trial Management System (CTMS): a centralized, digital solution that transforms the way we monitor, track, and manage clinical trials. CTMS is software that enables research teams to plan, track, and manage all aspects of a clinical trial from a single interface. When it comes to monitoring, CTMS is awesome. HOWEVER, it is also very expensive.

For those of us that love working with small, cash-strapped companies we get to make our own version of CTMS. Enter: EXCEL! While it can't replace a full-featured CTMS, it is affordable, customizable, flexible, and easy to share. With a bit of structure and planning, Excel can be a powerful tool for basic clinical trial monitoring and tracking.

As a CTM keeping track of clinical trial monitoring activities is essential for ensuring the quality, compliance, and success of a clinical study- it is the single best way to demonstrate the oversight of the trial activities, and an essential document for proving compliance to the monitoring plan. In this blog post, I'll show you my DIY clinical trial monitoring tracking system, so you can stay compliant, organized, and on top of your study monitoring without the big tech budget.

Monitoring Tracking.xlsx

Download XLSX • 22KB

No matter how you do it, a monitoring tracker must demonstrate/ track:

Regulatory Compliance

Regulatory authorities like the FDA, EMA, and other global bodies require documented oversight of clinical trials. Keeping a centralized record of monitoring activities and documents is invaluable following staff turnover or during audit preparation or during an audit

Protect Patient Safety

A centralized place to track monitoring activities ensures that:

• Site visits are being conducted

• Pertinent issues are being followed

• Transparency is available

Tracking issues and their actions ensures timely intervention and promotes patient well-being.

Maintain Data Integrity

Documented monitoring activities help ensure:

• Accurate source data verification (SDV)

• Timely resolution of queries

• Detection of data trends or issues early

Without tracking monitoring findings, data inconsistencies may go unnoticed, impacting the credibility of the study results

Proactive Issue Management

When you consistently track visits, issues, and actions:

• Recurring issues can be flagged across sites

• Corrective and preventive actions (CAPAs) can be implemented

• Site performance can be evaluated objectively

This supports a risk-based monitoring approach and avoids surprises during audits or inspections.

Facilitate Audits and Inspections

Auditors and inspectors will want to see:

• Monitoring visit reports

• Issue logs and resolutions

• Communication records

• Follow-up actions

A clear monitoring tracker helps the CTM track the monitoring activities and follow-up on identified issues. Tracking monitoring activities also demonstrates adherence to SOPs and shows that the study is under active oversight.

Support Study Team Communication

Documenting monitoring activities in a centralized tracker allows CRAs, trial managers, and leadership to:

• Stay aligned across sites

• Share findings and best practices

• Ensure that follow-up actions are completed

This reduces miscommunication and keeps the entire team on the same page.

Final Thoughts

Keeping track of clinical trial monitoring activities isn’t just a regulatory requirement- it’s a best practice that ensures participant safety, data quality, and study success. Whether you use a CTMS, Excel, or another tool, process ownership, consistent documentation, and follow-up are critical to running a compliant and high-quality trial.