Based on the project Gantt chart as of 01 Nov 2019, an interim analysis is scheduled to occur early Q2 of 2020. All of the following are valid for initially assessing the status of data cleanliness EXCEPT:
A.
Determining CRF data entry status of received pages
B.
Identifying missing pages where visits have been completed to date
C.
Identifying the number of discrepancies resolved to date
D.
Identifying all outstanding discrepancies to date and aging
When initially assessingdata cleanlinessin preparation for aninterim analysis, the focus should be onoutstanding issuesthat could affect data completeness and reliability.
According to theGCDMP (Chapter: Data Quality Assurance and Control), key indicators of readiness include:
TheCRF data entry statusof received pages (option A) to confirm completeness.
Identification ofmissing pages or visits(option B) to verify subject-level completeness.
A listing ofoutstanding discrepancies and their aging(option D) to assess unresolved data issues.
Counting the number ofdiscrepancies resolved to date (option C), however, does not reflect data quality or current data readiness—it indicates past actions rather than current unresolved risks. Therefore, it isnot a valid measurefor assessing interim data cleanliness.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 6.1 – Data Readiness Assessments for Analysis
ICH E6 (R2) GCP, Section 5.18.4 – Ongoing Data Quality Review
FDA Guidance for Industry: Oversight of Clinical Investigations – Risk-Based Monitoring, Section 7 – Data Quality Indicators
Contribute your Thoughts:
Chosen Answer:
This is a voting comment (?). You can switch to a simple comment. It is better to Upvote an existing comment if you don't have anything to add.
Submit