TheData Manager (DM)plays a critical role in maintaining transparent communication with the clinical study team regardingdata quality and study progress. One of the most essential metrics regularly reported by the DM is thepercentage of data entered and cleaned.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Communication and Study Reporting), these metrics provide insight into study status, data readiness for interim analysis, and timeline predictability for database lock. Regular communication includes:

Percent of CRFs entered and verified

Percent of queries resolved

Outstanding data issues or missing pages

Other options fall outside the Data Manager’s direct responsibility:

A (Enrollment)is typically reported by clinical operations.

B (Staffing changes)are handled by site management.

D (Safety events)are communicated by the safety/pharmacovigilance team.

Thus,option Ccorrectly reflects the Data Manager’s responsibility for ongoing study communication.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Communication and Study Reporting, Section 5.3 – Study Metrics and Status Updates

ICH E6(R2) GCP, Section 5.1.1 – Communication and Oversight in Quality Management

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.5 – Data Status Reporting