Exact(7)
Sessions will highlight industry experience implementing these approaches, and discussion topics will include but not limited to safety assessment and aggregate analysis, as well as potential best practices for unblinding of data and trial integrity, identifying expected/anticipated events, and determining reporting thresholds.
Identified trial groups were contacted for access to their individual patient data and trial protocols.
I found the chapters with tables of current data and trial results were more informative than those without.
To minimise bias, the UCD should be independently verified by expert reviewers, blinded to death certificate data and trial arm.
Experience shows that proactive on-site monitoring (eg, peer review) can enhance the quality of data and trial processes (eg, participant consent).
Overall data and trial management will be provided by the Clinical Trials Research Unit (CTRU) (University of Leeds, UK) where received data will be monitored for quality and completeness.
Similar(53)
Clinical research at Yale is moving forward rapidly with a major clinical trials recruitment campaign, branding initiative, and new system for data and trials management.
All data and trial-related documentation were independently audited by Paul L Clark and Associates (Beaumaris Victoria, Australia).
Both BH and BR were involved in acquisition of data, selection of studies, data extraction and trial quality assessment.
Five authors (BT, SB, AV, AK, SS) independently assessed trial eligibility, extracted data, and evaluated trial bias risk.
We kindly thank Karina Pusch for her support in data collection and trial management.
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