D2.4 Cleansed substance data for use within the EU regulatory network

EU-SRS is making use of G-SRS Software developed by the US FDA and NCATS.
Next to the (technical) implementation of EU-SRS for use in Europe, the Substance Validation Group
(SVG) provided feedback to the EMA SMS team on the validity of the substance data in EMA's SMS
system. This work was much appreciated since it significantly increased the quality of substance data
in SMS; these data are fed to other (EMA) systems and published on EMA's SPOR portal.
The SVG made use of the software called Sporify to perform data cleansing. The Sporify software
was slightly customized for the work to be performed, allowing a workflow for the data cleansing
activities (feedback, peer review, indication of required changes, status of the cleansing per record).
The cleansing of data occurred in parallel with establishing the naming rules for substances (see also
deliverable D2.8). A large portion of the feedback on substance data was possible to implement
without problems in SMS. Some suggested changes could not be implemented in SMS due to knockon effects on other systems. Work-arounds were implemented.
• Confirmed records received an "SVG validation flag" with value=1
• Substances agreed to be incorrect, but where deprecation is postponed received "SVG
validation flag = 0"
• For a number of records, the SVG indicated the need to update the preferred term. In case
this could not be implemented (either for confidentiality reasons or for technical reasons), the
SVG indicated preferred term was marked with "substance validation group as name source.
In EU-SRS, this name is implemented as preferred term.
The SVG has mapped the SMS records to the US UNII. The mapped codes, so SMSID/UNII, were
provided to EMA, uploaded into SMS and published on the SPOR portal.