Disambiguation of Clinical Database Validation and Clinical Data Validation

Validating a clinical database means testing the software.

Validating clinical data means testing the data in the software.

So the difference is between testing the container and testing the contents.

Similarities

Both validation of a clinical database and validation of clinical data:

• Are processes to ensure the quality and consistency of the system being validated.
• Require significant documentation.
• Are required by various regulations and guidances.

Differences

Clinical database validation and clinical data validation are notably different in timing, documentation, and procedures.

Timing

Clinical database validation should be completely finished before any real data are entered. Validation of clinical data occurs only once the data have started being entered and usually cannot be completed until all data have been entered.

Documentation

Software validation, which includes database validation, has a specific set of terms and expected documents that are generally consistent across GxP systems – see FDA guidances, industry standards references, or the Ofni Systems website. Validation of clinical data does not use the same documentation as software validation, and the terms and documents are not as well defined in regulations or industry standards. In addition, the documentation is significantly dependent on the software used to implement the data validation. These factors make clinical data validation documents different from, and more variable than, database validation documents.

Procedures

Since the timing and documentation are different, the procedures have to be different also.