A study team member suggests that data for a small, 50-patient, 2-year study can be...

The most critical consideration is thatdata cleaning is an iterative process, and completing all necessary steps — includingquery generation, site resolution, and second-pass validation— cannot realistically be accomplished within two weeks after study close.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), data cleaning must occurcontinuously throughout the study, not only at the end. Post-database lock activities typically include running final validation checks, resolving outstanding queries, performing reconciliation (e.g., SAEs, labs, coding), and conducting final quality review.

Even in small studies,query turnaround and response cyclesfrom sites take time — typically2–4 weeks per iteration— making a two-week total cleaning period unrealistic.

Therefore,Option Dis correct: it would take more than two weeks to handle second-round (follow-up) queries and confirm final resolutions prior to database lock.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.4 – Ongoing vs. End-of-Study Data Cleaning

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Quality and Timeliness

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations – Data Management and Cleaning