The core responsibility of a Clinical Data Manager (CDM) is to ensure the quality, integrity, and timeliness of clinical trial data. A key performance indicator (KPI) for this function is the status of data collection and cleaning. Communicating the percentage of data that has been entered into the database and the percentage that has been cleaned (i.e., all queries resolved) provides the entire study team with a clear, quantifiable measure of data management progress against project timelines. This metric is fundamental for study oversight, resource planning, and preparing for interim analyses and final database lock.

A. Planned versus actual enrollment: This is a primary metric for the Clinical Operations or Project Management team to track site performance and overall study recruitment progress.
B. Site staffing changes: This is an operational issue managed by the Clinical Research Associate (CRA) and the Clinical Operations team responsible for site management.
D. Serious and unexpected safety events: The reporting of these events is the specific responsibility of the drug safety or pharmacovigilance department, not the Data Manager.

1. Society for Clinical Data Management (SCDM). Good Clinical Data Management Practices (GCDMP), v2. 2023.

Section 15.4, "Metrics and Key Performance Indicators (KPIs)": This section explicitly lists metrics that are essential for data management to report on regularly. It states, "Examples of metrics include... Data Entry status (e.g., % of CRFs entered)... Data Cleaning status (e.g., % of CRFs clean, number of open queries)." This directly supports option C as a core, regular communication from the Data Manager.

2. Krishnankutty, B., Bellary, S., Kumar, N. B. R., & Moodahadu, L. S. (2012). Data management in clinical research: An overview. Indian Journal of Pharmacology, 44(2), 168–172. https://doi.org/10.4103/0253-7613.93842

Page 171, "Data processing and database locking": The article discusses the data management lifecycle, highlighting that "The data is then cleaned to ensure that it is complete and accurate... The CDM team provides regular status reports to the project manager." These reports inherently include the status of data entry and cleaning.

3. Gresle, L., et al. (2021). Development of a core outcome set for clinical data management (COSC-DM). Trials, 22(1), 829. https://doi.org/10.1186/s13063-021-05791-z

Table 2, "Final core outcome set for clinical data management": This peer-reviewed publication identifies key outcomes for data management. Under the domain "Data Quality," it lists "Completeness of the clinical database," which is directly measured and reported by metrics like the percent of data entered and cleaned.