TheStatisticianis responsible for assessing theoverall impact of data errors on the analysis and study results.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Quality Assurance and Control)andICH E9 (Statistical Principles for Clinical Trials), while theData Managerensures data accuracy and completeness through cleaning and validation, theStatisticiandetermines whether the observed data discrepancies are statistically significant or if they may affect thevalidity, power, or interpretabilityof the study’s outcomes.

TheQuality Auditor (C)identifies and reports issues but does not quantify analytical impact. TheInvestigator (D)is responsible for clinical oversight, not statistical assessment. Thus, after a database audit, theStatistician (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