Digital Study Report


This turnkey service delivers a digitized extract of the PDF Study Report for use by 3rd Party SEND preparers or CROs; and for QC checks of separately prepared SEND datasets.

Lack of quality and consistency of SEND datasets with Study Reports has always proven to be troublesome since 2018 when SEND was mandated. A recent check in March 2022 of 28 studies done by reputable CROs showed that not a single study was safe to be used for regulatory decisions. They had incorrect trial design domains, wrong study metadata, incorrectly populated data, and missing data published in the Study Report.

The DSR service delivers a digital study report tabulated for machine readability, and contains all the required study metadata and summary tables in the study report, as well as a complete set of Trial Design domains informed by the actual study design used in the study according to the Study Report. DSR carries the digital extracts of the Study Director’s conclusions. DSR can be used to QC check the SEND dataset by re-generating the summaries published in the Study Report for the same cohorts and groups. This process is called “reconciliation” because it is used to correct errors in either the SEND dataset or the DSR by reconciling all differences, since the two should be the same. After reconciliation, the DSR is an accurate digital representation of the Study Report and the SEND data accurately reflects the Study Report. To avoid having to write scripts, you may use the Xbiom platform which includes a Reconciler and eDataValidator for performing all checks regarding the SEND dataset.

Business Benefits

  • Digital data in the same terminology as the Study Report complements the actual PDF Study Report
  • Eliminate manual checks using a reconciler – high quality, reduce cost and time
  • Capture Study Director’s conclusion in digital format
  • Availability of all study metadata for use in TS.xpt and the other SEND domains