Development Safety Update Report

CIOMS. The development safety update report (DSUR) harmonizing the format and content for periodic safety reporting during clinical trials (Report of CIOMS Working Group VII). Geneva Counsil for International Organizations of Medical Sciences 2006. 

Davis B, Southworth H (2016) Statistical analysis of cumulative serious adverse event data from development safety update reports. Ther Innov Regul Sci 50 188-194 Xia A, Jiang Q (2014) Statistical evaluation of drug safety data. Ther Innov Regul Sci 48 109-120... 

Regulations for ICT in the healthcare sector are presented in this section, with their impact on managing safety within the Trust s ICT department, for development and operational use. The impact is in the area of formal and evidenced management of safety the safety case report is identified as a key artefact to be planned, produced and maintained. The updates to EC directives for stand-alone software as a medical device are discussed. 

The safety case, safety case report and supporting activities were the key to developing a safety management strategy. When the regulations were updated, some parts of the necessary response were aheady in place within the Trust, but not all. 

The plant Safety Analysis Report, updated in 1996, the operational documentation and the operational feedback database were used as background documents for the review. In addition, the results of a PSA Level 1 study developed for full power, low power and shutdown operational regimes were available for the review, as well as specific analyses of internal flooding and fires. Plant design documentation was also used to an appropriate extent. However, it should be emphasized that due to the hmited scope and time available for the review, the objectives of the screening were more related to verification of the applicabihty of the approach than to evaluation of the safety status of the plant. Therefore, this section cannot be considered as a formal safety review of the plant. 

Considering the significance of the safety improvements in Shutdown and Low-Power operating modes, the extent of activity in the area over the last several years and the fact that methods are well profiled, the OECD-NEA Task Force 13 initiated an activity to develop an update of the 1993 report. The aim was to provide a compendium of practices on safety improvements/enhancements in Shutdown and Low-Power operation modes. In addition, this should be a continuation of efforts in compiling the plans, methods and experiences in the area from the different OECD countries. 

Some companies have a suite of metrics that they update weekly, monthly, or quarterly depending upon their needs. This data is usually system performance metrics that summarize the status of activities or metrics determined to be of interest. These systems can provide process safety information as soon as it is developed and entered into a network database. With the proper access, operators and craft personnel and their supervisors can view this information, and nearly any audience can view the reported data in a predetermined format. 

Note that it can be particularly helpful to reissue the safety case shortly after go-live (Version 3 in this example). This provides the safety case developer with the opportunity to monitor immediate post-go-live issues, often a time when many functional and non-functional defects are recognised. The identification and resolution of these issues can be concisely wrapped up in a post-go-live report with any newly established hazards, causes or controls neatly highlighted. This version of the report will often carry the systan through live service perhaps requiring only minor updates as and when changes are implemented or when new information comes to light. 

The risk level of the Norwegian offshore petroleum industry has been analysed and presented on an annual basis by PSA. The scope of this risk level work covers all aspects of health, environment and safety (HES) within the authority s jurisdiction (Vinnem 2010). The first report was presented early in 2001, based on data for the 1996-2000 period. The methods used to collect data and analyse the risks were developed through the Risk Level Project (RNNP). Since then, annual updates have been performed. Also, since its beginning, RNNP as a tool has been undergoing development in cooperation with different stakeholders (Petroleum Safety Authority Norway 2009b). 

Develop and implement comprehensive motor carrier safety and loss control program. Conduct and monitor accident reporting and investigation. Inspect facilities, equipment, and property for existing or potentially hazardous conditions. Recommend corrective/preventive measures to reduce risk. Analyze and update safety policies, procedures, and plans to promote a safe working environment and increase safety awareness. Identifies, monitors, evaluates, and tracks all safety activities through audits and statistical analysis. 

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