Annual Safety Report Research Articles

Обґрунтування факторів впливу на безпеку руху

Збірник наукових праць «ДОРОГИ І МОСТИ» www.dorogimosti.org.uaISSN 2524-0994. Dorogi i mosti, 2021. Issue 23ТРАНСПОРТНІ ТЕХНОЛОГІЇ21312. Annual safety report 2018. URL: https://ec.europa.eu/transport/road_safety/sites/roadsafety/files/pdf/statistics/dacota/asr2018.pdf (Last accessed: 01.12.2020) [in English].13. Monitorynh dorozhno-transportnykh pryhod na avtomobilnykh dorohakh zahalnoho korystuvannya derzhavnoho znachennya Ukrayiny za 2018 rik [Monitoring of road accidents on public roads of state importance of Ukraine in 2018] : report. DP «DerzhdorNDI». Kyiv, 2019. 73 p. [in Ukrainian].14. Dmytrychenko M.F., Lanovyy O.T., Polishchuk V.P. Systemolohiya na transporti. Tekhnolohiya naukovykh doslidzhen’ i tekhnichnoyi tvorchosti (Knyha 2) [Systemology in transport. Technology of scientific research and technical creativity (Book 2)]. Kyiv, 2007. 318 p. [in Ukrainian].15. Duran B., Odel P. Klasterniy analiz [Cluster Analysis]. Moscow, 1977. 128 p. [in Russian].16. Zhambu M. Yerarkhycheskii klaster-analiz i sootvetstviya [Hierarchical cluster analysis and correspondences]. Moscow, 1988. 342 p. [in Russian].17. Holdberg A.M., Kozlov V.S. Obshchaya teoriya statistiki [General theory of statistics]. Moscow, 1985. 367 p. [in Russian].Volodymyr Kaskiv1, Ph.D., Associate Prof., https://orcid.org/0000-0002-8074-6798Yevheniia Shapenko2, Ph.D., https://orcid.org/0000-0003-0937-9400Oksana Hulchak2, Ph.D., Associate Prof., https://orcid.org/0000-0001-8186-4529Andrii Vozniuk3,https://orcid.org/0000-0002-7611-96521 M.P. Shulgin State Road Research Institute State Enterprise – DerzhdorNDI SE, Kyiv, Ukraine2 National Transport University, Kyiv, Ukraine 3 State Road Agency of Ukraine (Ukravtodor), Kyiv, Ukraine SUBSTANTIATION OF FACTORS OF INFLUENCE ON TRAFFIC SAFETYAbsractVelocity of personal vehicles or traffic flow for a certain period of time and on a certain section of the road is the main indicator that characterizes the impact of road conditions, environment, technical condition of the car and psychophysiological factors on the driver.To evaluate the each factor impact of on the velocity, survey was conducted on the M-06Kyiv – Chop road. A cluster analysis of field observation data was performed using the Statistica 12 software, connections were established in the middle of the data set, and the obtained data were organized into certain structures. As a result of the clustering, groups of clusters that have the greatest impact on speed were identified. Determining the hierarchy of factors influencing the speed and safety of the transport process shall improve approaches for modeling traffic flow velocity dependences. The paper describes an analysis of road safety risk factors.Problem Statement. The need to modernize approaches for traffic flow prediction, traffic volume distribution on the road network, means and methods of traffic management, traffic management systems in connection with quantitative and qualitative changes in the transport sector of Ukraine.Purpose. Road safety risk factors validation and ranking.Materials and method. Mathematical modeling and cluster analysis using survey data.Results. The dependence of speed on road conditions was improved using mathematical modeling.Conclusions. The hierarchy of factors influencing the speed and safety of the transport process is determined.Keywords: analysis, cluster, safety, road, method, model, velocity.

코퍼스(Corpus) 기반 항공안전영어 어휘 리스트 구축: IATA의 Safety Report를 중심으로

The purpose of this study is to suggest the implications for ESP learners based on Corpus by constructing and analyzing the Airline’s Safety Report published by IATA. Linguistic corpus for ESP study has been researched a lot, as it was frequently applied to English education. Listing the high-frequent vocabulary is essential for ESP learners. So it could be an efficient approach to introduce contents for ESP-related discipline. Therefore, annual safety reports for the last 5 years have been collected to make a list and extracted from corpus program called AntConc 3.5.8. The total number of word types from text was 7820 while 301,914 token numbers were shown. First of all, top 50 vocabulary list was extracted according to the order of high frequency. Secondly, lexical bundle list was extracted with 2, 3 and 4 words. Lastly, the concordance list of vocabulary ‘risk’ and ‘safety’ was checked. Through the results of this research, developed lists could be used as a useful tool for those who are studying in Aviation service major at college in the ESP classes or who is about to fly under the training at airlines. Compared to the importance and interest in aviation safety, this study presented a list of major vocabulary based on a language data analysis program in a situation where there was almost no research on related Airline Safety English.

Object Detection at Level Crossing Using Deep Learning.

Multiple projects within the rail industry across different regions have been initiated to address the issue of over-population. These expansion plans and upgrade of technologies increases the number of intersections, junctions, and level crossings. A level crossing is where a railway line is crossed by a road or right of way on the level without the use of a tunnel or bridge. Level crossings still pose a significant risk to the public, which often leads to serious accidents between rail, road, and footpath users and the risk is dependent on their unpredictable behavior. For Great Britain, there were three fatalities and 385 near misses at level crossings in 2015–2016. Furthermore, in its annual safety report, the Rail Safety and Standards Board (RSSB) highlighted the risk of incidents at level crossings during 2016/17 with a further six fatalities at level crossings including four pedestrians and two road vehicles. The relevant authorities have suggested an upgrade of the existing sensing system and the integration of new novel technology at level crossings. The present work addresses this key issue and discusses the current sensing systems along with the relevant algorithms used for post-processing the information. The given information is adequate for a manual operator to make a decision or start an automated operational cycle. Traditional sensors have certain limitations and are often installed as a “single sensor”. The single sensor does not provide sufficient information; hence another sensor is required. The algorithms integrated with these sensing systems rely on the traditional approach, where background pixels are compared with new pixels. Such an approach is not effective in a dynamic and complex environment. The proposed model integrates deep learning technology with the current Vision system (e.g., CCTV to detect and localize an object at a level crossing). The proposed sensing system should be able to detect and localize particular objects (e.g., pedestrians, bicycles, and vehicles at level crossing areas.) The radar system is also discussed for a “two out of two” logic interlocking system in case of fail-mechanism. Different techniques to train a deep learning model are discussed along with their respective results. The model achieved an accuracy of about 88% from the MobileNet model for classification and a loss metric of 0.092 for object detection. Some related future work is also discussed.

Risks Associated with Aircraft Maintenance in European Commercial Air Transport

In the 2016 EASA Annual Safety Report, 1318 incidents were categorised as involving a safety issue related to aircraft maintenance. All the Key Risk Areas, or most frequent outcomes, for aircraft maintenance as a safety issue were shown to be related but associated Rulemaking Tasks have not yet appeared in the 2017-2021 European Plan for Aviation Safety. Categorising EU-wide incident reports appears to be difficult due to the use and construction of the ‘Event Types’, or contributing causes, taxonomy used in the reporting tool. Previously developed taxonomies are either limited in the number of categories due to limited information in reports, or they are aimed more at an investigation than straight reporting. As a result, these taxonomies are not suited for use in a reporting tool, and these taxonomies lack the detail for focused feedback to the maintenance industry. Thus, a two-level taxonomy has been developed within this study, using a high-level overview of the maintenance process as a basis for the first level and a variation of descriptions, both specific and more broad-spectrum, for the second level. A set of 3910 incident reports from the central repository were analysed, causing 2677 incidents to be excluded for a variety of reasons such as a lack of information (the narrative was empty in 1100 reports or 28%), or the use of a language other than English (814 incidents, 21%). The remaining 1232 incident reports were categorised using the new taxonomy. Of these, 361 incidents occurred during installation of components (29%) and 308 incidents were related to maintenance control (25%). The increased level of detail from the new taxonomy allows for identification of procedure types that are more susceptible to errors, such as installing or removing components or deferral of a defect so that an aircraft can be dispatched. This will hopefully lead to increased vigilance as well as further measures to increase safety.

Surrounding traffic complexity analysis for efficient and stable conflict resolution

The constant increase in air traffic demand increases a probability of the separation minima infringements in certain areas as a consequence of increased traffic density. The Annual Safety Report 2016 reports that in recent years the number of infringements, measured per million flight hours, had been increased at a lower rate (Eurocontrol, 2018). However, this level of infringements still generates a continuous pressure on the air traffic control (ATC) system and seeks for more control resources ready to tactically solve potential conflicts, while increasing at the same time the operational costs. Considering present air traffic management (ATM) trade-off criteria: increased airspace capacity and traffic efficiency but reducing the cost while preserving safety, new services must be designed to distribute the separation management ATC task loads among other actors. Based on the Single European Sky Air Traffic Management Research and Next Generation Air Transportation System initiatives, this paper proposes an innovative separation management service to shift the completely centralized tactical ATC interventions to more efficient decentralized tactical operations relying on an advanced surrounding traffic analysis tool, to preserve the safety indicators while considering the operational efficiency. A developed methodology for the proposed service is an application-oriented, trying to respond to characteristics and requirements of the current operational environment. The paper further analysis the traffic complexity taking into consideration the so-called domino effect, i.e. a number of the surrounding aircraft causally involved in the separation management service by the means of identification of the spatiotemporal interdependencies between them and the conflicting aircraft. This complexity is driven by the interdependencies structure and expressed as a time-criticality in quantifying the total number of the system solutions, that varies over time as the aircraft are approaching to each other. The results from two randomly selected ecosystem scenarios, extracted from a simulated traffic, illustrate different avoidance capacities for a given look-ahead time and the system solutions counts, that in discrete moments reach zero value.

Giving A Hand To Pilots With Animated Alarms Based On Mirror System Functioning

Controlled Flight Into Terrain (CFIT) accidents are among the most frequent and deadly accidents in aviation (IATA, 2016). Pilots have sometimes only a few seconds to react to the ‘Pull-Up’ alarm that indicates an imminent collision with the ground. The auditory modality of the alarm can generate stress, which can disrupt cognitive processes (Porcelli et al., 2008) and negatively impact the ability to take timely and appropriate actions (Scholz et al., 2009). While in general humans are less sensitive to auditory stimuli than to visual stimuli (Mrugalska et al. 2016), the auditory component of the ‘Pull-Up’ alarm is loud and prominent whereas its visual component is more discreet (i.e., small text). Consequently, a first step to enhance the efficiency of this alarm would be to increase the conspicuity of its visual component by enlarging the ‘Pull-Up’ text size and to increase its salience by displacing it from the artificial horizon to the bottom of the Primary Flight Display (PFD). However, enlarging the inscription may not be sufficient to cope with the loss of cognitive performance due to stress (BEA, 2009). Previous researched found that watching an action activates premotor cortex and pre-initiates the gesture imitation through the mirror neuron system (Ocampo & Kritikos, 2011). Therefore, presenting a video of the gesture to perform (i.e., a hand pulling the sidestick), in case of imminent impact with the ground, should pre-activate the motor reaction to the alarm and then improve the pilots’ performance in terms of reaction time. The present experiment aimed at assessing whether these ‘Pull-Up’ video better performance than more conventional ‘Pull-Up’ alarms. Both behavioral and electroencephalographic (EEG) results were used to assess the best alarm design.

Safety-related outcomes of the Japanese Society of Hepato-Biliary-Pancreatic Surgery board certification system for expert surgeons.

We investigated safety-related outcomes of hepatobiliary pancreatic (HBP) surgeries performed after establishment of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS) board certification system for expert surgeons. We analyzed post-HBP surgery mortality data obtained from annual safety reports provided by board-certified training institutions between 2012 and 2015. The 90-day mortality rate for the 53,929 high-level HBP surgeries performed at board-certified training institutions was 1.7%. The 30-day mortality rates for 2012, 2013, 2014, and 2015 were 0.9%, 0.7%, 0.6%, and 0.6%, respectively, and the 90-day mortality rates were 2.1%, 1.8%, 1.6%, and 1.3%, respectively, with significant decreases in both. The surgeries with high 4-year cumulative mortality rates were left hepatic trisectionectomy (10.3%), hepatopancreatectomy (7.6%), liver transplant recipient surgery (6.7%), hepatectomy with extrahepatic bile duct resection (4.6%), and right hepatic trisectionectomy (4.5%). Over the 4-year period, the number of operations increased, but the 90-day mortality rates for these surgeries, with the exception of right trisectionectomy, decreased. The JSHBPS board certification system for expert surgeons has significantly decreased mortality subsequent to high-level HBP surgeries. Reducing mortality associated with high-risk HBP surgeries will be our next challenge.

Keep on flying [Numbers Don't Lie

YOU MIGHT THINK 2014 WAS A BAD YEAR FOR FLYING. There were four highly publicized accidents–the still-mysterious disappearance of Malaysia Airlines Flight 370 in March, the shooting down of Malaysia Airlines Flight 17 over Ukraine in July, AirAsia Flight QZ8501 falling into the Java Sea in December, and finally, in July, the Air Algerie Flight 5017 crash in Mali, for a total of 815 dead. · But according to Ascend, the consulting branch of Flightglobal that monitors aircraft accidents, 2014 in fact had the best accident rate in history: one fatality per 2.38 million flights, compared to the previous best of one per 2.37 million in 2012. True, Ascend did not count the downing of MH Flight 17, which was an act of war, not an accident. · In any case, it's better to personalize the problem by putting it in terms of the risk per passenger per hour of flight. The necessary data are in the annual safety report by the International Civil Aviation Organization, which covers large jetliners as well as smaller commuter planes. · In 2013, 32.1 million domestic and international flights carried 3.1 billion people, logged 5.8 trillion passenger-kilometers, and experienced 90 accidents, causing 173 fatalities. With the mean flight time at about 2.2 hours, this implies roughly 6.8 billion of passenger-hours or 2.5 × 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-8</sup> fatalities per person per hour in the air. For large jetliners—dominated by Airbuses and Boeings and regional jets made by Canada's Bombardier and Brazil's Embraer–the risk that year was just 1 × 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-8</sup> . In 2014, large jetliner accidents (excluding the MH17) would have pushed the latter rate to about 8 × 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-8</sup> , but the mean for the past decade remains at historic lows.

President's Page

In 1951, SEG established a committee on safety to further the cause of accident prevention in the geophysical industry (Sorge, 1952). This became known as the SEG Safety Committee and its work is further evidenced by Safety Committee annual reports for 1973, 1974, 1977, and 1979 that can be found in the archives of Geophysics. At the SPE International Conference on Health, Safety, and Environment in March of this year, Threadgold (2014) mentioned that this SEG committee was officially dissolved in 1985, a fact recorded in the SEG Board minutes. Its last known annual safety report was issued for 1982 (Proubasta, 1987).

Patient safety in anaesthesia

Patient safety in anaesthesia

Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011

The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE).While recognising the importance of compliance with this Directive, which is not optimal in some member states of the European Union, it would be constructive to simplify further and harmonise its application in every country. Without necessarily resorting to a revision, some of the Directive’s dispositions could be improved, such as the definition of “investigational medicinal products” (IMP) and what should be considered as “substantial amendements”, as well as harmonising and improving the way in which Ethics Committees are run, either on a European Commission level, or by relying more on the European Network of Research Ethics Committees (EUREC) which already exists in several European member states.Other points in the Directive do require revision, especially those relating to:• the definition of the respective roles of Ethics Committees and Competent Authorities.• the simplification of safety information to Ethics Committees (giving them access to the Eudravigilance database for adverse reactions occurring during clinical trials and providing them with only new safety issues or with a summary of the Annual Safety Report).• the possibility of one single European authorisation for the trial, centralised and/or decentralised, when the trial is multinational.The recommended changes could be made within the scope of a European Regulation, avoiding the need to transpose it at a later date into each country’s regulations, which is a source of possible lack of harmonisation. More specifically, for trials with institutional sponsors and/or investigator driven trials such as “drug therapy strategy trials”, modulating restrictions according to the “risk added by the research” would enable the trial’s organisation to be simplified regarding monitoring, adverse reactions reporting and study drugs labelling.

The Development Safety Update Report

This article gives an overview of the current status of the development safety update report (DSUR) guideline, provides a rationale for some of the key sections of the report and highlights the practical implications of its implementation for clinical trial sponsors and other parties. The DSUR aims to provide a periodic analysis of the evolving safety profile of an investigational drug, and actions proposed or being taken to address safety concerns during the clinical development of an investigational drug. The draft guideline, published for consultation in mid-2008 in the International Conference on Harmonisation regions of Europe, Japan and the US, is intended to be the common standard for the format, content and timing of annual safety reports to regulators, replacing existing reports such as the US investigational new drug annual report and the EU annual safety report.

Directive 2001/20/EC on Good Clinical Practice in Clinical Trials

The final version of the European Union (EU) Clinical Trials Directive (2001/20/EC) was published in the Official Journal of the European Communities on 1 May 2001,[1] and is also available on the Commission’s website.[2] The full title is Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Member States were required to prepare national provisions for complying with the Directive by 1 May 2003 and bring the provisions of the Directive into force by 1 May 2004. Non-compliance with the requirements of the Directive would become a criminal offence once the Directive has been adopted into national laws and implemented. The Directive required the European Commission to issue guidance about the requirements of the Directive and how they should be applied. Final versions of the guidance documents were released in April 2003.[3] What is summarised here are the key issues in the Directive and Guidance with reference to pharmacovigilance, highlighting potential implications. The key issues for pharmacovigilance include reporting requirements, expedited reporting, investigator responsibility, sponsor responsibility, safety communication to investigators, annual safety reports, Eudravigilance – clinical trial module/electronic submission of suspected unexpected serious adverse reactions (SUSARs) and pharmacovigilance audit as part of Good Clinical Practice (GCP) audit. The Directive and Guidance have introduced additional requirements, which will have resource implications for pharmacovigilance and data management departments. Annual safety reporting (line listing/summary tabulation of all serious adverse reactions [SARs] and a report of subjects’ safety) would be required. The report on subjects’ safety is a risk-benefit evaluation of the trial concerned and requires more information than that collected for serious adverse events (SAEs). The implication is that safety data (other than SAEs) and denominator data to aid risk-benefit evaluation should be collected in real time, reviewed and entered on the relevant databases ready for the annual report. The quality of annual reports would depend on what data are available and the skills and expertise of staff reviewing and interpreting the data. The skills of highly qualified and experienced staff including physicians, epidemiologists and statisticians would be needed. Emphasis is shifting from processing and reporting individual cases of SAEs to ongoing cumulative review of safety data, interpreting safety data, identifying risk at early stage and communicating risk in a timely manner. Where a sponsor conducts several clinical trials with the same investigational medicinal product (IMP), the annual safety report should be based on the experience from all clinical trials performed by the sponsor and all available data. For ease of production of annual safety reporting and safety monitoring, centralising pharmacovigilance activities for all studies of a single IMP including setting up a central pharmacovigilance database earlier on in the development programme should be considered. The use of ‘all adverse events’ in the Guidance is confusing: “The sponsor has to keep detailed records of all adverse events (AEs) reported to him by the investigator(s) and perform an evaluation with respect to seriousness, causality and expectedness”. Some companies have interpreted this to mean that real time reviews as currently performed for SAEs would be required for non-serious AEs. This would have major resource implications for pharmacovigilance departments.