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Benefits of eSource for the Principal Investigator in a Clinical Trial

According to a pharma FDA auditor, the biggest issue for compliance in clinical trials is oversight by principal investigators – or the lack thereof. As the principal investigator in a clinical trial, you are responsible for overseeing and managing various aspects of clinical research including data collection. Historically, this oversight can be tedious. Manual data entry can lead to errors and increased workloads. You have to continually ensure the accuracy and integrity of data that’s collected – in addition to the confidentiality and security of that data. You manage this all while navigating complex regulatory frameworks. 

To take one big step toward alleviating these concerns around data capture and setting your trials up for better compliance, consider shifting to eSource. Why? Take a look at these 3 top benefits of eSource for PIs.

(1) eSource simplifies the accuracy of data input and the oversight of the site team.

eSource solutions can reduce protocol deviations just by the way they are designed. These solutions can equip users with templates and validation settings that support improved legibility and can flag instances when numbers like pulse rate are entered in an incorrect range, indicating a keystroke error. According to the Association of Clinical Research Professionals, one study showed a 38% reduction in deviation rate when eSource was implemented on a clinical trial, versus traditional paper source.

When a site team has this built-in support, the data you ultimately review is more likely to be correct, reducing workload.

(2) Remote access allows real-time oversight of eSource data across all trials to improve management efficiency and consistency.

When your team collects source data on paper, you have to be onsite to review it. With eSource, you can provide oversight from anywhere. When you can access digitized study data remotely, your workflow becomes more flexible and efficient. With remote eSource access, you can instantly review the most up-to-date data for real-time oversight no matter where you are or what time it is. This allows you to quickly identify problems with data across multiple site team members and even multiple trials, so you can promptly address them remotely to prevent protocol deviations. This cohesive management approach prevents delays in the team’s workflow as well as your own, so you can all adhere to trial timelines set by the sponsor. 

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(3) eSource systems automatically generate a digital audit trail for easy reference in questions of data accuracy and compliance.

An audit trail of source data is critical for establishing transparency, accountability, and data integrity during a study. eSource data can be attributed automatically to each person logging it in the digital system. With this detailed record of who is accessing the data and who is updating it, you can easily track and verify modifications to build a comprehensive, verifiable data history throughout the trial. You can also efficiently follow up with users who are inputting data, when questions about accuracy or patient safety come up. Lastly, automated audit trails are a key resource when you need to prove compliance with protocol requirements and regulatory standards. Not only can this help you pass an audit, it helps your site build trust and demonstrate transparency with an auditor.

Choose the right solution to maximize efficiency and compliance.

By overseeing digital data entry with eSource, you can reduce errors across your trials to ensure optimal outcomes. StudyTeam’s eSource suite was designed with each of these benefits in mind:

  • Data validation. Site teams are able to set ranges in certain fields to help prevent keystroke errors.
  • Remote access. You can review and e-sign source documents from anywhere, at any time.
  • Real-time oversight across trials. You can log into one system (StudyTeam) to access and review all source data across all trials you’re working on.
  • Access to an automatic audit trail. With no effort, you can tap into a full audit history of uploads, signatures, and changes, timestamped and attributed to individual users.

With the right data capture process in place, you can ensure adherence to protocols and regulatory standards across each of your trials. You can confirm the accuracy and integrity of data collected by each site team to contribute to high-quality, reliable results in your trials.

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