Delegation Logs and Decentralized Chaos: The New Oversight Liability Nobody Wants to Own

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  Edye T. Edens, JD, MA, CIP, CCRP / 1 month
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By Edye T. Edens, JD, MA, CIP, CCRP Clinical research oversight is built on a deceptively simple foundation: the investigator is responsible for the conduct of the trial. But as decentralized and hybrid designs have fractured traditional site models, that clarity has eroded. What remains is a system in which sponsors and CROs, often with the best of intentions, are pushing sites toward practices that quietly violate the very regulations those same sponsors must uphold. The Delegation Log DilemmaAt the heart of the issue is the DOA log — the seemingly straightforward record of who does what under a principal investigator’s supervision. Under 21 CFR 312.60, only individuals under the investigator’s direct supervision, within their reasonable control, should appear on that log. Yet inspection findings increasingly show a troubling pattern: sponsors and CROs requiring sites to list external, third party vendors — home-health nurses, patient-facing telemedicine subcontractors, or third-party recruitment firms — who are not employed, trained, or overseen by the investigator. The rationale, often unstated, is contractual liability management: if everyone is on the log, everyone is “covered”. But that approach directly conflicts with FDA’s interpretation of investigator oversight.Inclusion on a DOA log cannot transfer responsibility. Nor can it cure the absence of supervision. The more expansive these logs become, the clearer the evidence that oversight boundaries are misunderstood — or ignored. It can also signal a lack of credibility to any and all parties that agreed to the approach. When Sponsors and CROs Create NoncomplianceIn practice, many sites are being placed in an impossible position. They can either (a) comply with the sponsor/CRO’s directive and risk violating 21 CFR 312.60, or (b) refuse to sign the log as written and risk delaying study activation. Neither option protects the integrity of the trial. This dynamic exposes a deeper problem: sponsors and CROs are clinging to delegation frameworks designed for 1990s site models. Modern studies now distribute trial conduct across technology vendors, decentralized care providers, and data platforms that fall well outside the PI’s control. Instead of redesigning the oversight model, many stakeholders have simply stretched old definitions until they snap. And when findings occur, the blame rarely flows upstream. FDA inspection reports routinely cite investigators for “failure to adequately supervise” without acknowledging that the oversight model itself was structurally defective. The Regulatory Reality CheckThe FDA’s BIMO inspections over the last two years reveal repeated citations tied to inadequate supervision in remote or multi-vendor trials. FDA inspectors are asking pointed questions: When those answers trace back to contracts rather than controls, findings follow. The investigator’s name remains on the 1572 but the system that set them up to fail often escapes scrutiny. Re-Defining Oversight for a Fragmented EcosystemIf decentralized and hybrid models are here to stay, the industry must confront an uncomfortable truth: oversight cannot be delegated by spreadsheet. True compliance in this new environment demands re-thinking the chain of accountability — clarifying which tasks fall within the PI’s supervision and which belong to independent operational structures governed by sponsor oversight. It also means documenting not just delegation, but verification: how the PI engages with remote teams, reviews source data, and ensures participant safety in practice, not just on paper. The alternative is a continuation of the current cycle — where sponsors push untenable documentation practices downstream, sites absorb the regulatory fallout, and everyone wonders why FDA inspection findings keep repeating the same themes year after year. The future of investigator oversight will depend less on technology than on governance. The question is whether the industry is willing to admit that the old model no longer fits the data-driven, decentralized reality we’ve built. Edye T. Edens, JD, MA, CIP, CCRPEdye T. Edens, JD, MA, CIP, CCRP, is the Founder and CEO of EEDEE Law – Life Sciences Law Group, a boutique firm at the intersection of law, compliance, and clinical research operations. Drawing on decades of experience across sponsors, sites, and academic medical centers, they help life sciences organizations navigate the complex realities of research compliance with clarity, practicality, and grit.