Observations that make me uncomfortable, page-2

A very detailed objective post. Congratulations on a good profit.

I know someone who owns a reg affairs Pharma company and I asked about the delay. I was told how vital the data lock stage is. It is not just a matter of 350 patients progressing and data lock is triggered. A data management program will be in place to ensure clean and clear data is submitted at data lock. Once data lock is triggered you data stands firm. Getting this stage right takes time and IMO this delay has been flagged by the company previously and should have been expected. After all of this time I would imagine they would rather delay and get things perfect instead of rush things through for the sake of a deadline.

DATA LOCK

After a proper quality check and assurance, the final data validation is run. If there are no discrepancies, the SAS datasets are finalized in consultation with the statistician. All data management activities should have been completed prior to database lock. To ensure this, a pre-lock checklist is used and completion of all activities is confirmed. This is done as the database cannot be changed in any manner after locking. Once the approval for locking is obtained from all stakeholders, the database is locked and clean data is extracted for statistical analysis. Generally, no modification in the database is possible. But in case of a critical issue or for other important operational reasons, privileged users can modify the data even after the database is locked. This, however, requires proper documentation and an audit trail has to be maintained with sufficient justification for updating the locked database. Data extraction is done from the final database after locking. This is followed by its archival.