Database Lock Without the Final-Week Scramble
Because SDTM mapping runs parallel to data collection in Trialhelix, database lock is a controlled procedure — not a crisis. The pre-lock checklist, validation reports, and signature workflow are structured into the platform.
Data Lock Procedure in Trialhelix
Pre-Lock Reconciliation Checklist
The CDM lead works through the structured pre-lock checklist: all queries resolved or formally closed, SDV completion at required percentage, MedDRA coding reviewed and approved, protocol deviation log finalized. Each item is checked off with user identity and timestamp.
SDTM Final Validation
A final Pinnacle 21 validation run is executed against all SDTM domains. Because mapping has been running throughout the study, the validation report is typically clean with only justified suppressions. The validation report is attached to the lock record.
Database Lock Signature
The CDM lead and the biostatistician both sign the database lock certificate with an electronic signature meeting 21 CFR Part 11 requirements — unique user credentials, timestamped, with meaning annotation ("I certify that the database is locked for analysis").
ADaM Dataset Generation
ADaM analysis datasets are generated from the locked SDTM data using the pre-specified derivation rules. ADAE, ADCM, ADLB, ADPC, and ADPP datasets are produced with variable labels, formats, and codelists matching the define.xml.
TLF and Package Delivery
TLFs are generated from the validated ADaM datasets. The full delivery package — SDTM datasets, ADaM datasets, define.xml, TLF volume, and reviewer's guides — is assembled for sponsor handoff in eCTD-compatible format.
What the Pre-Lock Checklist Covers
Query Resolution Status
All open queries must be resolved, closed with reason, or formally accepted as data issues. Aging query summary report shows the CDM lead which queries require action before the lock decision.
SDV Completion
SDV completion percentage is tracked per site, form, and data element category. Critical data elements (primary endpoints, safety data) require 100% SDV completion before lock. Non-critical data follows the risk-based monitoring plan thresholds.
Medical Coding Review
All AE verbatim terms must be coded to MedDRA PT and SOC, reviewed by the medical coder, and approved by the CDM lead. Concomitant medications must be coded to WHODrug if required by the SAP.
Protocol Deviation Finalization
All protocol deviations must be classified (major/minor/important) and approved by the medical monitor before lock. The deviation listing feeds directly to the SDTM DV domain and the deviation summary TLF.
See the Data Lock Workflow on Your Study
The data lock checklist and signature workflow can be demonstrated in a 30-minute call. We can show the state of your SDTM domains from day one through lock.