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ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced it 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.”
SITEpro enables biopharmaceutical companies to capture important Clinical Outcome Assessments (COAs) – including patient, clinician, and observer reported outcomes (PROs, ClinROs, and ObsROs) -- via an easy-to-use electronic tablet. SITEpro increases clinical trial efficiencies by delivering error-free data directly from the user and eliminates costly transcription errors, out-of-range entries, illegible responses, and double data entry associated with paper-based studies.
“We relied on Professor Jones’ expertise to ensure that patients completing the SGRQ and SQRQ-C on the SITEpro Tablet would provide data of the highest quality and reliability,” said Bob Young, Executive Vice President, COA Solutions, ERT. “This authorization presents a valuable addition to our comprehensive line of centralized respiratory services which deliver significant benefits to our customers who are developing medical products for the treatment of asthma and COPD.”
For more information on SITEpro Tablet and ERT’s proven electronic data collection solutions for respiratory clinical trials, please visit www.ert.com.