In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

According to international and U.S. federal regulations, the sponsor holds the ultimate responsibility for the quality and integrity of trial data. This includes implementing and maintaining quality assurance systems. For electronic data capture (EDC) systems used in a multi-site trial, the sponsor must ensure the system is validated to be accurate, reliable, and perform consistently as intended. The sponsor selects, qualifies, and oversees the EDC vendor and ensures the system complies with regulations like 21 CFR Part 11 and ICH E6(R2) across all participating sites. This centralized responsibility ensures uniformity and control over the data management process for the entire study.

A. Institution: The institution is responsible for trial conduct at its specific location but not for validating a multi-site electronic system provided by the sponsor.

C. Regulatory authority: Regulatory authorities (e.g., FDA) set the compliance requirements and conduct inspections, but they do not actively manage or ensure a specific system's compliance; that is the sponsor's duty.

D. Investigator: The investigator is responsible for the accuracy of the data entered at their site but not for the technical validation and compliance of the overall EDC system itself.

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Section 5.5.3, "Electronic Trial Data Handling and Remote Electronic Trial Data Systems." This section explicitly details the sponsor's responsibility to ensure and document that electronic data processing systems are validated and conform to established requirements for completeness, accuracy, reliability, and consistent intended performance.

2. U.S. Food and Drug Administration. (2003). Code of Federal Regulations, Title 21, Part 11, Electronic Records; Electronic Signatures. Section 11.10(a), "Controls for closed systems." This regulation requires that persons using closed electronic record systems must "employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records," including the validation of systems to ensure accuracy and reliability. In a sponsored trial, this "person" is the sponsor.

3. Johns Hopkins University. (n.d.). Investigator Responsibilities - FAQs. Johns Hopkins Medicine. Retrieved from the Office of Human Subjects Research Institutional Review Board website. The guidance clarifies that while investigators are responsible for data at their site, the sponsor is responsible for "selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s)... and ensuring that the investigation(s) is conducted in accordance with the general investigational plan." This oversight includes the systems used for data collection.