Explain the audit trail functionality in ePROs How are data backups and disaster recovery handled for ePRO data?

Oct 26, 2017 ... An additional section has been added in order to capture information related to the echocardiographic sub-study. 6.3 Recording of adverse events. Studies in cancer suggest that ePROM symptom monitoring may be associated with enhanced patient ... All study information will be archived in the BEAR ... Aug 27, 2013 ... Continuous Safety Monitoring for Randomized Controlled Clinical Trials with Blinded Treatment Information ... ePRO, web-based ... Feb 20, 2025 ... Section 2.10 states that “All clinical trial information should be recorded, ... electronically: The past, present, and promise of ePRO ... treatment with improvements obtained in earlier clinical trials. A ... Paper presented at the Drug Information Association Conference on Benefits and Challenges. Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.1 (Final) Prepared by the CDISC CDASH Team Notes ... Patients entered. ePRO symptom data for their health care teams to view on the ... technology in cancer clinical trials. JCO Clin Cancer Inform. 2018;2:1-11 ... Feb 25, 2022 ... ... trial investigators, can be blinded to avoid putting clinical trial information in jeopardy. ... ePRO (Electronic Patient-Reported Outcomes) ... over time can be informative to clinicians and researchers seeking to ... this study can be used to prepare ePRO/clinical data for toxicity prediction ... Feb 6, 2018 ... ... information that should be included in clinical trial protocols. It ... ePRO Good Research Practices Task Force report. Value Health ...