Protocol Number Consistency

Consistency Between Tables Check

Introduction 

A Clinical Trial Protocol ID, or protocol number, is the number or character sequence used by the Clinical Trial Sponsor to uniquely identify the investigational protocol of the specific drug or vaccine. In all TLFs of a study, the protocol number should be identical.

Purpose

Validates that the protocol number is identical across the study compared to the one inserted by the user.

Applicability 

Inclusion conditions 

• Tables, listings and Figures in drug studies only 

Exclusion 

• Empty table
• Vaccine studies

Discrepancies

• Protocol number is not equal to the reference
• Protocol number is missing

Discrepancy Example

The protocol number is missing from the table title.