The Statistician is responsible for assessing the overall impact of data errors on the analysis and study results.
According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Quality Assurance and Control) and ICH E9 (Statistical Principles for Clinical Trials), while the Data Manager ensures data accuracy and completeness through cleaning and validation, the Statistician determines whether the observed data discrepancies are statistically significant or if they may affect the validity, power, or interpretability of the study's outcomes.
The Quality Auditor (C) identifies and reports issues but does not quantify analytical impact. The Investigator (D) is responsible for clinical oversight, not statistical assessment. Thus, after a database audit, the Statistician (B) performs a formal evaluation to determine whether the magnitude and nature of the errors could bias results or require reanalysis.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 7.3 - Data Audit and Impact Assessment ICH E9 - Statistical Principles for Clinical Trials, Section 3.2 - Data Quality and Analysis Impact Assessment FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations - Data Validation and Analysis Review