Bridging the Gap Between IND Safety Reporting and Routine Clinical Practice: Operational, Cognitive, and Training...

Patient safety event documentation in routine clinical practice and safety reporting for clinical studies conducted under Investigational New Drug (IND) regulations each operate within established but fundamentally different frameworks. Each framework has distinct documentation objectives, reporting pathways, terminology, and accountability structures, and the 2 frameworks lack sufficient overlap to allow site staff to move and transition fluidly between them. This commentary distinguishes IND safety reporting obligations from routine clinical documentation, identifies common training gaps, and proposes a practical training framework for investigators and support staff at research sites.

This commentary draws on published literature, regulatory guidance documents, and existing frameworks for clinical trial training and adverse event reporting to examine the cognitive and operational sources of confusion at the investigative site level.

Adverse event documentation and reporting for studies conducted under IND approval are well-discussed, keystone activities required to maintain regulatory approval and advance drug development. What is less thoroughly appreciated is the volume of information required for appropriate documentation and its impact on the timeliness of initial reporting. Site staff frequently encounter difficulty managing follow-up requests or clarifications within required timeframes, driven by structural mismatches between clinical and regulatory frameworks, inadequate role-based training, and the cognitive burden of switching between clinical care and research reporting modes.

Structured, role-based safety training grounded in the regulatory context, operationalized within workflows, and aligned with the proportionality principles of ICH E6(R3) is essential for improving IND safety reporting at investigative sites. Such training should be positioned not merely as a compliance intervention but as a participant-protection intervention.