Describe the data security and recovery measures for ePROs How are system updates and maintenance performed on ePRO platforms?

May 23, 2023 ... ... ePRO symptom monitoring between clinic visits) or no comparator depending on study design. ... No systems provided patients with general ... PROMIS addressed a need in the clinical research community for a rigorously tested patient reported outcome (PRO) measurement tool that uses recent advances in ... Apr 21, 2022 ... Evidence supporting the adoption of PROMs in clinical practice. Prospective trials and population-based studies have demonstrated improved ... On the one hand, this kind of data provides valuable information from outside the idealized setting of clinical trials; on the other hand, it is problematic ... A database build directly influences the quality of the study data and is an important part of a medical device study. The regulatory informational needs from ... Mar 9, 2023 ... ... information that will be collected via ePRO and how that information ... information related to the clinical trial to the trial participant and. Feb 7, 2018 ... based guidance on PRO-specific information that should be in- cluded in clinical trial protocols. ... ePRO Good Research Practices Task Force ... Apr 24, 2025 ... Its primary aim is to develop and clinically assess 2 new ePRO-based palliative care interventions for adults and children, along with their ... Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.1 (Final) Prepared by the CDISC CDASH Team Notes ... Studies in cancer suggest that ePROM symptom monitoring may be associated with enhanced patient ... All study information will be archived in the BEAR ...