News By: Emily Norris

Protocol deviations are a familiar part of clinical research, yet historically there has been little regulatory clarity around their classification and management. Clinical teams are now expected to demonstrate stronger inspection readiness, consistent deviation classification, and well-reasoned documentation. By applying the new structure and definitions, clinical research professionals will be able to strengthen deviation categorization and reduce operational risk across diverse study environments.

Delays to study start-up can undermine clinical research timelines and efficiency. All stakeholders should engage in overcoming these delays. In a new white paper, the Site-Sponsor Consortium advocates for harmonization of Confidentiality Disclosure Agreements (CDAs). These pre-negotiated agreements between a sponsor/contract research organization and a site/institution are an efficient solution, covering confidentiality for future feasibility activities and studies.

Major clinical trial–related policy changes at the U.S. Department of Health and Human Services (HHS) are leading to ambiguity for sites, sponsors, and contract research organizations. Questions remain on how clinical research professionals can best operationalize these changes, align processes, and address compliance challenges.