Data Management and Informatics
From source to submission dataset
Data management questions test the path a data point travels: source document, entry into the eCRF, validation, query, resolution, coding, and lock. Know the standards: CDASH governs what is collected at the site, SDTM governs how it is submitted, and controlled terminology plus MedDRA and WHO Drug dictionaries standardize coding. Edit checks are programmed validation rules that raise discrepancies; a query is the formal communication asking the site to review, and every query carries an audit trail.
Data integrity rests on ALCOA+ and on Part 11-style controls for electronic records: unique user accounts, no shared logins, validated secure systems, and an audit trail that is computer-generated, time-stamped, and cannot be disabled or altered by users. Corrections must preserve the original value, the new value, the reason, and who made the change and when. Database lock occurs only after data entry is complete, queries are closed, SAE reconciliation against the safety database is performed, and coding is reviewed; any post-lock change requires an auditable process.
Trap: treating transferred data as verified data. Transfer is not cleaning, and external data such as central labs usually require a reconciliation step.
Rule of thumb: ask what the audit trail would show. Worked example: a coordinator realizes a visit date was entered one day off. She must not overwrite it; a query is raised or answered, the correct date is entered with a reason for change, and the system retains the original value, her identity and the timestamp. Erasing the error destroys record integrity even though the new value is correct.