The purpose of this document is to give guidance to Receiving Authorities on the evaluation of the GLP compliance status of nonclinical safety studies submitted for regulatory purposes. This guidance does not address the scientific evaluation and interpretation of the submitted data or the risk assessment based on these data.

The West Bengal Health Department on Saturday formed teams to support surveillance and monitoring of treatment at five hospitals treating COVID-19 patients in the city. The team members will pay regular visits to these hospitals and send reports to the department, the state government said in an order. The department has also set up a dedicated help line for issues regarding the non-availability of PPEs and other supplies. The feedback and suggestions will be duly recorded and acted upon by the state government for appropriate remedial measures, the order said. The West Bengal government has also constituted a team for guidance on containment activities in different districts of the state.

The state health department has also set up a dedicated helpline for issues regarding the non-availability of PPEs and other supplies.

The team members will pay regular visits to these hospitals and send reports to the department, the state government said in an order.

Compact X-ray sources based on inverse Compton scattering provide brilliant and partially coherent X-rays in a laboratory environment. The cross section for inverse Compton scattering is very small, requiring high-power laser systems as well as small laser and electron beam sizes at the interaction point to generate sufficient flux. Therefore, these systems are very sensitive to distortions which change the overlap between the two beams. In order to monitor X-ray source position, size and flux in parallel to experiments, the beam-position monitor proposed here comprises a small knife edge whose image is acquired with an X-ray camera specifically designed to intercept only a very small fraction of the X-ray beam. Based on the source position drift recorded with the monitor, a closed-loop feedback stabilizes the X-ray source position by adjusting the laser beam trajectory. A decrease of long-term source position drifts by more than one order of magnitude is demonstrated with this device. Consequently, such a closed-loop feedback system which enables stabilization of source position drifts and flux of inverse Compton sources in parallel to experiments has a significant impact on the performance of these sources.

In southeastern Greenland, two rivers of ice named Helheim and Kangerdlugssuaq flow in spurts and starts toward the coast. They are much like any other […]

The post Astrophysical Observatory scientists are monitoring the mysterious movements of glaciers appeared first on Smithsonian Insider.

Now here is something to ruminate on. About 85 percent of the methane produced by a cow comes out of its mouth as burps. The […]

The post Monitoring methane? Now there is a better way to measure appeared first on Smithsonian Insider.

Knowing what we take from our oceans matters. Smithsonian scientists are developing tools to better understand and protect our oceans. One project they are working […]

The post Monitoring seafood catch data appeared first on Smithsonian Insider.

Long-term population trends for some North American pollinators -- bees, birds, bats, and other animals and insects that spread pollen so plant fertilization can occur -- are demonstrably downward, says a new report from the National Research Council.

A review of the available evidence underscores the safety of the federal childhood immunization schedule, says a new report from the Institute of Medicine.

Over the last 25 years, deep-water oil and gas production in the Gulf of Mexico has increased significantly.

The 2011 Fukushima Daiichi nuclear accident should serve as a wake-up call to nuclear plant operators and regulators on the critical importance of measuring, maintaining, and restoring cooling in spent fuel pools during severe accidents and terrorist attacks, says a new report from the National Academies of Sciences, Engineering, and Medicine.

To improve and ensure the efficacy of restoration efforts in the Gulf of Mexico following Deepwater Horizon – the largest oil spill in U.S. history – a new report from the National Academies of Sciences, Engineering, and Medicine recommends a set of best practices for monitoring and evaluating ecological restoration activities.

Black lung disease cases in coal miners have been increasing since 2000 for uncertain reasons.

To help determine if the descendants of Gulf War and post-9/11 veterans are at risk for health effects resulting from the service members’ exposure to toxicants during deployment, a new report from the National Academies of Sciences, Engineering, and Medicine recommends the creation of a health monitoring and research program (HMRP).

A new study of pollutants in Mediterranean coastal waters assesses the risks posed by difficult-to-detect chemicals present at low concentrations. Coastal monitoring programmes may be required to control discharges of some of these pollutants, which, at current levels, could be harmful to sensitive marine creatures.

A survey of over 600 private boats docked in marinas throughout the Mediterranean showed that 71% are carrying non-indigenous species. In certain cases, non-indigenous species can become ‘invasive’ and have enormous and long-lasting impacts on ecosystems. The findings suggest that a common monitoring strategy may be necessary to prevent further disruptions to natural ecosystems.

Monitoring the effects of chemicals in the human body provides useful data for assessing and managing environmental risks to health, but it also raises ethical questions about how the results of such studies should be reported to participants. New research suggests that changes are needed to the research process to allow study participants to play a greater role in interpreting, disseminating and using the results.

Published to mark the 20th anniversary of the Habitats Directive, this latest Thematic issue examines the challenges and successes in managing and restoring biodiversity in the Natura 2000 network.

Networks of wireless sensors could be used to monitor traffic noise. A new study shows that the wifi sensor systems, although slightly less accurate than precision noise monitoring systems, can provide detailed information, with dense coverage, about traffic noise over a longer period. Their low cost and low energy requirements make them particularly suitable and attractive for use by local authorities or even community groups.

This Thematic Issue provides a flavour of recent work by scientists in the area of biodiversity monitoring to highlight both up-to-date approaches to conservation and evaluation, and how long-term monitoring data could be used more effectively in management and policy decisions.

In-depth soil information is increasingly required to achieve an array of environmental and economic goals. In particular, accurate estimates of soil carbon stocks are necessary to guide land-management practices and climate- related policymaking. To help meet this need, Australian scientists have developed a new sensing method to analyse cylindrical soil samples (soil cores), known as the Soil Condition ANalysis System (SCANS). By integrating a novel automated soil- core sensing system (CSS) with advanced statistical analytics and modelling, the SCANS provides a level of detail that is difficult to achieve with existing alternatives. SCANS is not only rapid, accurate and inexpensive1, but is likely to be a useful tool for farmers, land managers and policymakers, as the improved assessment of soil functions, structures and carbon stocks will facilitate more informed, sustainable decision-making.

Using open-access software and power saving technologies, researchers have developed an easily deployed, low-cost network for monitoring large areas of the Amazon rainforest. This Peruvian study shows that environmental information, such as soil moisture and rates of photosynthesis, can be recorded and uploaded to the internet without having to make repeated visits to remote areas.

Effective regulation of genetically modified organisms (GMOs) calls for monitoring of the potential environmental risks. This study explored whether the German permanent soil monitoring programme could be a useful tool for this purpose. The researchers say the programme has potential to monitor the effects of GMOs on local soil communities, but that adaptations would be necessary.

Recent work in the coastal Mediterranean waters of the ‘Comunidad Valencia’ in Eastern Spain confirms that wastewater treatment plants (WWTPs) are a significant source of pollutants that need monitoring under the Water Framework Directive (WFD) and Priority Substances Directive. However, these substances also directly enter coastal waters from mixed urban, industrial and agricultural sources, creating a challenge for the development of control measures.

New research has examined the impact of Produced Water (PW) discharges from a Norwegian oil field, using mussels to monitor the quality of the environment. The findings indicated the effectiveness of a bio-monitoring approach to study the chemical and biological influences of off-shore exploitation activities.

A better understanding of existing nitrate monitoring systems in European waters could greatly improve efforts to reduce nitrate pollution, a major cause of poor water quality, according to new research from Portugal.

Algal blooms in inland and marine waters could be detected and monitored more accurately in future, thanks to a new assessment method. Scientists have developed a new algorithm for sensors which identify emerging blooms of cyanobacteria based on the behaviour of light reflected by the algae’s pigment. Importantly, the algorithm may reduce uncertainty in estimations of algal concentrations by distinguishing between two different types of pigment.

Sustainable river management is increasingly informed by hydromorphological stream assessments — evaluations and classifications of stream conditions which account for both hydrological (the movement, distribution and quantity of water) and geomorphological (the processes and forms deriving from the interactions of water and sediment movement) features. In order to provide a more accurate and comprehensive assessment of river character and dynamics, scientists have developed three novel methods. Together, these tools represent a promising technique for conducting collaborative assessment and monitoring of river conditions in Europe.

Restoring ecosystems in estuaries and along coasts is an important part of European environmental policy. A new analysis of degraded ecosystems has indicated that, although some restoration can take less than five years, when there has been a century of degradation, it can take a minimum of 15-25 years.

New research has explored how well different governance systems can achieve desirable conservation outcomes. Results confirmed the importance of adaptive management, which relies on regular monitoring to enable 'learning through doing' to refine actions, and suggested that leadership using expert knowledge was also significant in successful governance.

To encourage protection of the environment, payments for environmental services (PES) schemes offer direct incentives to individuals and communities to maintain or improve the provision of environmental services. A recent study suggests indicators to monitor PES must be chosen very carefully to help ensure that monitoring does not cost more than the payments themselves.

The first ever European-wide study of bird monitoring practices reveals a wide range of monitoring protocols. The researchers provide recommendations for improving bird monitoring programmes, in particular, for those involving large numbers of volunteers.

Monitoring biodiversity on farms is vital for conservation policies but how much does it cost? In a new pan-European study, researchers develop a standardised monitoring programme and estimate it will cost an average of €8 200 per farm to conduct. This cost could be dramatically cut if volunteer ‘citizen scientists’ or farmers help gather data for the programmes.

Long-term biological monitoring is key to effective, evidence-based conservation management, new research concludes. However, greater collaboration is needed to ensure that scientists understand what kind of information is needed by conservation managers. In this way the data can deliver answers for the most important management questions.

Citizen scientists are increasingly playing an important role in monitoring environmental conditions around the world. There have been concerns, however, that the quality of volunteer data might not match the reliability of data collected by professional scientists. A new study has found that both citizen scientists and professional scientists were able to identify widespread decreases in the cover of live corals and increases in rubble and sand, during two long-term monitoring programmes of coral reefs. These results show that volunteers can indeed play a meaningful role in the conservation of these reefs, say the authors of this study.

Genetic identification of species through ‘metabarcoding’ offers a reliable, cost-effective way of producing biodiversity information for policymakers and managers, concludes an international study. The researchers show how the method can be used to help assess the impacts of environmental change and management on biodiversity.

Better monitoring is needed to safeguard the Antarctic against threats posed by invasive alien species, according to a new study. The authors developed ‘the Antarctic Biological Invasions Indicator’ (ABII) to help generate data for tracking trends in alien invasions and the measures taken to prevent them.

Human activities, including industrial development along coastal areas, risk polluting the marine environment with heavy metals which can harm human health and aquatic life. A recent study has found elevated levels of metal pollution in the Jade area of the German Wadden Sea, but concludes that metal contamination of the sediments would not be expected to have harmful effects on the marine environment and living organisms here.

Pharmaceutical pollution of marine environments has important biological consequences for aquatic organisms. This study investigated the effects on mussels of treatment with environmentally relevant levels of an antidepressant, fluoxetine, and a beta-blocker, propranolol, using biomarkers including DNA damage. The results showed that mussels are most vulnerable to these drugs in combination.

The framework for a Europe-wide biomonitoring programme has been established by a new study. The preliminary investigation of 17 European countries showed that monitored levels of toxic chemicals varied significantly between countries. Although the levels were mostly within recognised health-based guidance values, in a few cases these values were exceeded. The researchers suggest that a fully-fledged European biomonitoring programme would help to develop policies to avert public health risks presented by environmental chemicals.

Chemicals are everywhere and new substances are regularly being introduced to the market. However, only some pose a risk to the environment. How do we decide which of them to monitor? A new study using a database of chemicals found in fish in the Baltic Sea has assessed which chemicals are commonly monitored. The researchers suggest that monitoring is biased towards known, already regulated hazardous chemicals, and recommend changes to address other chemicals.

Researchers have developed a new approach to hierarchise pesticides based on their risk to or via the aquatic environment, which has been implemented in the Pinios River Basin of Central Greece. The analysis indicated that a number of pesticides were found in concentrations that could cause negative impacts on aquatic ecosystems. The results provide detailed information to inform decisions regarding the monitoring of pesticides in the Pinios River Basin and outline an approach that could be used in other watersheds.

The presence of disinfection by-products (DBPs) in drinking water is an emerging health concern. DBPs come in many classes and are chemically diverse, making them challenging to monitor. Swedish researchers have evaluated a new method for the simultaneous determination of a broader range of DBPs than typically possible using other available techniques. The method uses gas chromatography (a laboratory technique that separates and analyses vaporisable compounds in a mixture), together with a halogen-specific detector (XSD). Having been tested in real water samples from two municipal waterworks in Sweden, the method has been optimised for the simultaneous determination of a wide range of neutral DBPs.

Croatian researchers have developed new indicators that can be used to analyse photochemical pollution and smog caused by ozone. The indicators are based on simple mathematical formulae and could make it easier for those who monitor pollution levels to make meaningful comparisons between different sites.

Acoustic Data has developed a remote downhole monitoring deployment model that overcomes travel restrictions tied to the COVID-19 pandemic.

U.S. federal budget woes are shrinking the monitoring network that tracks greenhouse gases such as methane.

･ First introduction for a geothermal power plant ･ Enhancing the operation and performance of power generating facilities in close cooperation with customers