Describe common challenges in ePRO implementation and validation How can sponsors prepare for regulatory inspections related to ePRO data?

... study site or study country in the ePRO ... Clinical Trials: Isolate Blinded Product Information; User Help: Isolate Blinded Clinical Trial Information ... The toolkit is designed to help healthcare systems govern, integrate, and report ePRO data for clinical care delivery. ... study and application of ePRO tools ... Sep 14, 2023 ... ... medicine using information technology. J Am Med Inform Assoc 8(4): ... ePRO measurement in clinical trials. Patient 8(4):301–309. Article ... Nov 1, 2024 ... Moreover, scientific societies, patient associations, cooperative groups, and institutions have their own clinical trial informational platforms ... IRT (IWRS, eDiary, ePRO) ... The contents available on the Everest Clinical Research Corporation website www.ecrscorp.com are intended for informational purposes ... Oct 21, 2020 ... It is increasingly likely that personal information collected in the course of clinical trials is not subject to the requirements of the CCPA or the CPRA with ... Studies of other ePRO systems have typically focused on ... Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis. Experienced clinical research professional with over 10 ... study specific informational guides or procedures (unique testing or constant wakefulness). PROMIS addressed a need in the clinical research community for a rigorously tested patient reported outcome (PRO) measurement tool that uses recent advances in ... Feb 7, 2018 ... based guidance on PRO-specific information that should be in- cluded in clinical trial protocols. ... ePRO Good Research Practices Task Force ...