Insights

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.

Women's History Month is a wonderful opportunity to celebrate women leaders. Hear from a group of high-achieving women—who will lead a Signature Series panel discussion at ACRP 2026— describe the leadership skills and learnings that helped advance their careers.

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.