EClinCloud Analysis Reviews 1,715 FDA Inspection Citations

Nov 2, 2026
EClinCloud found that protocol compliance, informed consent and investigator case histories accounted for 46.2% of citation occurrences in FDA inspection data from fiscal 2020 through 2025.

EClinCloud, which sells clinical trial software, reviewed 1,715 citation occurrences in FDA Bioresearch Monitoring inspection data from fiscal 2020 through 2025, the company said in a press release. Protocol compliance, informed consent and investigator case histories accounted for 793 occurrences, or 46.2% of the total.

The figures sum citation frequency fields across 479 selected rows in FDA inspection observation workbooks. They represent cited obligations, not defect rates, inspection outcomes or final determinations that violations occurred.

EClinCloud said trial master file reviews should assess whether records establish ownership, identity, timing, version history, related decisions, retrieval and preservation. Its electronic trial master file software provides AI suggested document classification with human confirmation, quality control before filing and tools for tracking completeness, timeliness and traceability. The company noted that software alone does not guarantee compliance or inspection outcomes.

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