Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis.

Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators' supervision, would gracefully solve these issues.

[Digital Pen & Paper® technology to manage clinical risk and to prevent medical malpractice claims].

The use of innovative technologies in the health sector can be a key element in clinical risk management. In order to reduce errors in medical recording and to provide medico-legal evidence, Digital Pen & Paper technology has been adopted by medical staff of a hospital in Milan. The Authors introduce the first results of this trial: notable advantages have been reported in compilation, transmission and storage of medical records.

Risk management strategies in the postmarketing period : safety experience with the US and European bosentan surveillance programmes.

In view of the shortcomings of the current system for postmarketing drug surveillance that is based on voluntary spontaneous adverse drug reaction (ADR) reporting, new approaches are needed. We describe an approach involving a combination of limited distribution, patient and physician education, as well as a novel pharmaco-vigilance system that is capable of promoting the safe and adequate use of a new drug. Importantly, it provides the possibility of calculating true ADR occurrence rates, as the exposed population (denominator) and the number of patients with events (numerator) are known.