On a dose escalation study, the Data Manager notices one site has a much higher...

The correct action is toconsult the CRO’s Lead Data Manager and CRO’s Project Leader(Option C) to ensure the issue is addressed through the appropriate oversight and escalation process.

According to theGCDMP (Chapter: Project Management and Communication), when a sponsor Data Manager identifies significant data management issues under CRO oversight — such as aging queries or site performance disparities — communication must followthe established governance and escalation pathwaydefined in the Scope of Work (SOW) and Data Management Plan (DMP).

Directly contacting the site (Option B) bypasses the CRO’s chain of command and violates communication protocols. Notifying only the Clinical Leader (Option A) is insufficient, and ignoring the issue (Option D) jeopardizes theData Safety Monitoring Board (DSMB)review timeline.

Therefore,Option Censures a documented, collaborative approach to problem resolution within the contractual oversight structure.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 7.1 – Oversight of CRO Data Management Activities

ICH E6 (R2) GCP, Section 5.2 – Contract Research Organization Responsibilities

FDA Guidance for Industry: Oversight of Clinical Investigations – Sponsor and CRO Roles and Communication Pathways