Beginner’s Guide to Compliant Electronic Source Data Capture

Are you using electronic source data capture?

According to ICH GCP 5.18 guidance, the purpose of trial monitoring is to verify each participant’s wellbeing is protected, data is accurate, and the trial is conducted in compliance with any regulatory requirements. Additionally, the Food & Drug Administration’s (FDA) Guidance for Industry establishes expectations for electronic source data capture, review, and retention. This guidance aims to help ensure source data’s reliability, quality, integrity, and traceability from electronic source to submission.

With today’s complex trials, the expectation of gathering faster results in an increasingly decentralized environment is only increasing, imploring investigators to implement electronic source data capture systems. How can researchers ensure this is done correctly? Leveraging the right technology to standardize a compliant process for source data capture is a proven way to reach these goals.

Why eSource is the ideal enabling technology

While electronic source data collection is not new, collecting source data in a variety of settings in a compliant manner is. With this in mind, how does one maintain data quality and integrity while ensuring participant safety and staying compliant?

The key is creating a truly decentralized process by incorporating electronic source data collection and management system into your workflow. Not to be confused with the more sponsor-centric process of an EDC, a comprehensive eSource system enables even the largest site networks and health systems to capture data from multiple locations immediately, automate quality checks across the enterprise, enable remote monitoring, and fast-track approvals from any location with a 21 CFR Part 11 compliant eSignature process. Beyond capturing screening and visit data effectively, a complete eSource system also helps team members, reviewers, and approvers to engage in 21 CFR part 11 compliant source data capture and management workflows with greater ease.

Compliant source data collection is essential to the validity and success of a clinical trial. Key contributors to a compliant decentralized process using a fully capable eSource system include:

• Ability to easily build forms and establish a consistent process
• Intuitive 21 CFR Part 11 compliant workflows for entering data into the eCRF from any location
• Alerts and reminders focused on maintaining data capture quality and integrity
• Fast assignment to a remote clinical investigator review and time stamped eSignature
• Secure access for a remote monitor to conduct source data verification (SDV)
• Process and status tracking across locations, with source document retention and full audit trail

The benefits are clear

Beyond the benefits of greater efficiency and savings over the cost of paper source documents, utilizing electronic source data capture also ensures a consistent ALCOA process. A key factor is the integrity of “contemporaneous” data entry with eSource during direct point of care/assessment of a human subjects. This decreases human error that often results from entering source data at a later date/time in a paper format. An eSource system actually enforces best practices by having researchers enter data in real time while assessments are being performed and collected, while the audit trail date/time stamps everything, better aligning the workflow for data integrity and ALCOA.

Introducing a comprehensive eSource system is key to keeping remote information organized and compliant. A consistent and compliant electronic process enables centralized oversight over many locations. Additionally, it enhances data integrity, encourages remote monitoring, enables timely eCRF completion, delivers faster payments, and promotes efficient remote procedures across your entire research organization.

A complete electronic 21 CFR Part 11 compliant source data system enables study workflows to capture source data in real-time, enhances data quality, allows remote monitoring, and optimizes site operations. This is important for ensuring a trial adheres to the Food & Drug Administration’s (FDA) guidance. Learn more about how Advarra eSource can support your remote workflows and compliance.

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