One or Two Pass Data Entry - Paper CRFs

When paper CRFs are used in a clinical trial, the sponsor (or data management staff as assigned) is tasked with entering data from the CRFs.  During the design phase of the Maestro database, the sponsor will decide if the mode will be the one or two pass data entry method.  One pass or single entry is when one person enters the data and may optionally be followed by some kind of review.  Two pass data entry, also called double data entry, is when two people independently enter the same data.  

If data entered during pass two doesn’t match that entered during pass one, a dialog box (‘Message from webpage’) pops onto the screen (see Figure 1 below) and displays the Pass 1 and Pass 2 values.  The user may keep the Pass 2 value by clicking “OK” or restore the Pass 1 value (the original value) by clicking “Cancel”. 

Figure 1: Two Pass Data Entry – Conflicting Value Message