Nonclinical Digital Study Report (DSR) - PointCross

 The availability of the Nonclinical Digital Study Report (DSR) is an exciting development that has the promise of making SEND better, safer to use, and actually useful for analysis. DSR is available in machine-readable columnar tabulation, making it easy to use the same tools used to read CDISC’s SEND. DSR retains the same data domains and terminology of observation and testnames as in the Study Report. DSR is a machine-readable companion to the published PDF Study Report.

DSR includes all the required study metadata, trial design domains reflecting the protocol, and the summary tables in the study report. DSR also carries a digital extracts of the Study Director’s “Results and Conclusions” in machine-readable form. A complete DSR may also include the individual subject level findings.

SEND is a CDISC standard for exchange of Nonclinical Study Data. In practice, SEND is almost always generated separate from the process that generates the Study Report, but using the same data collection LIMS source. The result is that the Study Report and SEND may not match, or may have significant gaps that make SEND unfamiliar or helpful to sponsor toxicologists and CRO Study Directors. For those reviewing a completed study using the Study Report, SEND is an unfamiliar organization of the same data with standardized terminology that is different from what is visible in the Study Report.

The DSR is an important solution and tool for the toxicology stakeholders at Sponsors and Regulatory agencies to:

• Reconcile a SEND dataset against the Study Report to identify and correct any discrepancy in either the report or SEND. The end results are three objects that represent the Study with quality and integrity —

1. A verified Study Report
2. A Digital Version of the Study Report that can be used like SEND with the same viewing and analysis tools except that the terminology and data domains reflect those in the Study Report (e.g. Hematology instead of LB), and
3. A verified SEND dataset with clearer nSDRGs.

• Review and Analyze the data published in the Study Report using a digital supplement, the DSR, making it easy for those familiar with the Study Report. A reviewer can easily create custom or clubbed-groups for more detailed analysis.
• Digitally extracted Results and Conclusions section so that the Study Director’s safety and treatment related noteworthy findings are available for search, generation of eCTD Section 2.6.7 Nonclinical Tabulated Summaries and for research purposes.

We keep DSR cost low, with most studies averaging between $4,000 — $6,000. To learn more or get in touch with a rep to discuss pricing and capabilities, please do not hesitate to reach out dsservices@pointcross.com

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