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ERT, a global solution provider for patient safety and efficacy endpoint data collection, has received authorization to provide electronic versions of the St. George’s Respiratory Questionnaires (SGRQ) on SITEpro Tablet—ERT’s electronic patient data collection system for use at clinical investigative sites. The authorization applies to the SGRQ, a 50-item questionnaire that measures health status and quality of life in patients with asthma and Chronic Obstructive Pulmonary Disease (COPD), and the SGRQ-C, a shorter version of the questionnaire developed specifically for COPD patients.
In order to receive authorization, ERT conducted a qualification study to verify that the migration of the questionnaires to ERT’s electronic platform remained faithful to its original paper version. ERT scientists successfully completed cognitive interviews among adult patients with asthma and COPD to confirm their understanding of the electronic versions of the questionnaires and that they are appropriate for use in clinical trials.
“We worked closely with ERT’s scientists as they migrated the SGRQ and SGRQ-C to the SITEpro Tablet and demonstrated that they are understood and can be used by patients as was intended with the original paper versions,” said Professor Paul Jones, St. Georges University of London, who developed the instrument. “We are pleased to authorize ERT’s electronic administration of the SGRQ and SGRQ-C to measure health status in patients with airway obstruction diseases during clinical development.”
Read the full release here.