Recalculating Clinical Subjects Requiring Source Data Verification

If you change the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field of a site record, then you must recalculate the value in the Total Subjects Requiring SDV field of that site record.

If you change the number of subjects in the site pool by changing the value in the SDV Required field of the site's subject records, then you must recalculate the value in the Total Subjects Requiring SDV field of the site record. If you change the number of subjects in other pools, such as the subject pool and the status pool, then you do not have to recalculate the value in Total Subjects Requiring SDV field because these other pools are not included in the calculation of this field. For more information about pools, see "Setting Up Partial Source Data Verification for Clinical Subjects".

To recalculate the subjects requiring source data verification 

1. Navigate to the Site Management screen, then the Protocol Site List view.

2. In the Protocol Site list, drill down on the site number field of a site record.

3. Navigate to the More Info view.

4. Click Reapply Auto-Select Rate.

   If the value in the Number of Initial Subjects field or the Subject Auto-Select Rate field changed, then the value in the Total Subjects Requiring SDV field is recalculated, and this recalculation considers the subjects in the site pool.