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There is a need to understand Workplace Based Assessment programs in Australia to improve future offerings. This paper evaluates the efficacy of a Workplace Based Assessment program at a single regional Australian healthcare location using a mixed-method approach to collect data from three sources. Tools included Mini-Clinical Evaluation Exercise, case-based discussion and in-training assessment, and structured face-to-face interviews with eighteen key-stakeholders. The Workplace Based Assessment program itself was evaluated against a number of indicators, including the psychometric properties assessed by each of the tools used. In addition, the adequacy of the current program and specifically the tools used within it to determine the clinical competence and safety of International Medical Graduates was examined. Lastly, satisfaction of key-stakeholders with program preparation and usability of tools was investigated. The results indicate that the tools currently used within the Workplace Based Assessment program continue to be reliable, and assessors are assessing International Medical Graduates with a high degree of consistency across the program. In addition, this study found that both International Medical Graduates and assessors remain satisfied with regard to confidence, usability and user perception of the current Workplace Based Assessment methods to provide a more meaningful experience for those being assessed. Overall, this evaluation provides insights into the current Workplace Based Assessment program and makes recommendations for future improvements. These include clearer program guidelines; greater opportunities for support of International Medical Graduates, feedback for and further training of assessors.

HIV endpoint-driven clinical trials in Africa enroll women who are at heightened risk of acquiring HIV. In 2017, the South African Medical Research Council recommended the provision of oral pre-exposure prophylaxis (PrEP) in HIV prevention trials, at which time the Evidence for Contraceptive Options and HIV Outcomes trial was ongoing and began to provide PrEP on-site at some trial sites. We interviewed 132 women who initiated PrEP on-site at the Durban, South Africa trial site to explore PrEP use, and conducted phone-based interviews 4–6 months post-trial exit to explore post-trial PrEP access. PrEP uptake was high (42.6%). Among women initiating PrEP on-site, 87.9% felt at risk of acquiring HIV. Most women (> 90%) heard of PrEP for the first time from study staff and three-quarters who initiated PrEP on-site continued at trial-exit. PrEP use declined post-trial exit with more than 50% of women discontinuing PrEP, and barriers relating to access emerged.

GGE biplot study is an effective tool for many crops including rice to identify mega-environments, ideal trial site and suitable genotypes for general and specific adaptation. An attempt was made to find promising T. Aus rice genotypes having suitable grain quality, better agronomic parameters and ideal test location for T. Aus rice growing areas. In this study, a total of 11 promising genotypes along with two popular cultivars BR26 and BRRI dhan48 were tested across six locations; Cumilla, Gazipur, Rajshahi, Rangpur in T. Aus 2016 and 2017 whereas Habiganj and Kushtia only in T. Aus 2017 season. From GGE biplot study, BRRI RS, Rajshahi (E8) was the most discriminating and ideal location for evaluating T. Aus rice genotypes in Bangladesh condition while BRRI RS, Cumilla 2016 (E1) showed the least discriminating ability and the least representative location. From two years combination data, BR9011-19-1-2 (G6) recorded the highest average grain yield (5.11±0.68 t ha-1) but BR9011-46-2-2 (G2) was the most stable genotype having grain yield (4.97±0.62 t ha-1) and other stable genotypes with above average yield were BR9011-67-4-1 (G5), BR9011-34-3-2 (G1), BRRI dhan48 (G13), BR9039-28-3-2 (G9) and BR9039-9-1-3 (G8) indicated that these genotypes adapted to favourable environments. BR26 (G12) was found highly variable and less stable across the test environments. In addition, agronomic trait (plant height, growth duration) and grain quality traits were also considered for suitability and wider adaptation in T. Aus growing areas in Bangladesh. BR9011-46-2-2 (G2) and BR9011-19-1-2 (G6) were the better genotypes in most of the locations but, considering all of the parameters, the newly developed rice breeding line BR9011-67-4-1 (G5) has been identified as suitable genotype to release as a new variety for sustainable T. Aus rice production in Bangladesh. Bangladesh Rice j. 2019, 23(2): 77-85

Understanding the growth pattern of trees of various provenances in response to climatic conditions provides information on the adaptive potential of trees. Intra-annual density fluctuations (IADFs) are anatomical markers of variations in wood density within the annual wood increment. Latewood-like cells within earlywood, resulting from severe drought during spring and early summer, express the structural adaptation of the wood tissue to unfavorable climatic conditions. In this study, we used two 40-year old IUFRO provenance trials of Norway spruce located in the western and north-eastern Poland to i) determine the effect of provenance on the IADF frequency and ii) to define the climatic factors determining the formation of IADF. Three highly polymorphic nuclear microsatellites are used to determine the differentiation among provenances in particular between the northern and southern Polish distribution area. Our results demonstrate that the frequency of all types of IADFs is determined by the growing conditions, and only the IADFs in the transition zone are determined by provenance origin. The highest variability between provenances in response to climatic differences was observed for IADF in transition zone, where temperatures and rainfall of spring and early summer differentiated northern and southern provenances. Moreover, the IADF frequency was influenced by drought, thereby differentiating provenances in terms of their sensitivity to severe conditions. Furthermore, environmental differentiation of climate-growth reaction was expressed by a stronger impact of climatic conditions observed in the western than in the northeastern trial site. The results of this study confirm the dependency of climate related changes in wood characteristics on provenance origin. Therefore, density fluctuations seem to be an appropriate adaptive trait for selecting Norway spruce provenances with varying degree of drought sensitivity.

Background/Aims Despite the increasing globalization of clinical trials, little is known regarding how the trial site costs vary around the world. We quantified the geographical distribution and regional cost differences for the clinical trials that established the benefits for new therapeutic drugs approved by the US Food and Drug Administration in 2015 and 2016. Methods We included all pivotal clinical trials for 59 new molecular entities approved by the US Food and Drug Administration in 2015 and 2016 that included at least one site in North America. We derived cost estimates from IQVIA’s CostPro, a global clinical trial cost-estimating tool used by pharmaceutical sponsors. We assessed the patient and site allocation of these trials across eight geographic regions. To quantify the region-specific cost differences, we conducted a within-trial comparison by expressing the estimated regional costs associated with the sites in each global region as a percent of the same costs in North America. We also estimated the percentage breakdown of regional cost components (pass-through, site management, regulatory, and study conduct costs) for each trial and for all endpoints reported the median and interquartile range. Results Overall, 127 pivotal clinical trials enrolled 91,415 patients from 13,264 sites. Most patients (60.3%) and sites (57.3%) were outside North America. A median of 66% of the total estimated trial costs (interquartile range: 60%–72%) were spent on regional tasks, with the largest share (53.3%) going directly to trial sites and the remainder going to other regional trial management tasks. Differences were greatest in four lower cost regions: Africa, with an estimated regional cost per site of 49% of North America (interquartile range: 44%–56%), Central Europe 50% (interquartile range: 41%–63%), Middle East 53% (interquartile range: 42%–64%) and Latin America 59% (interquartile range: 50%–70%). Overall, 90 (71%) of the 127 pivotal trials had a total of 3160 sites in these lower cost regions. In contrast, savings were more limited in Western Europe, Oceania, and Asia, where estimated regional costs were 78% of North America (interquartile range: 67%–89%). One-quarter of the trials with sites in Asia and Oceana did not achieve cost savings in those regions relative to North America. Conclusion Among this sample of pivotal trials for recently approved US Food and Drug Administration products, most patients and sites enrolled were outside of North America, with selection of regional sites having a significant impact on total trial costs.

Coordinated intensive sweet cherry canopy architecture/rootstock trials were planted in 2010 across North America at 13 diverse sites under the NC140 regional rootstock research project. The diverse canopy architectures include two “three-dimensional” canopies: 1) a single central leader with 15 to 20+ lateral fruiting branches in a conical canopy (tall spindle axe, TSA) and 2) a multiple leader bush-like canopy with 8 to 15 upright narrow fruiting mini-leaders (Kym green bush, KGB); plus two “planar” canopies: 1) a single central leader with 20 to 30+ short lateral fruiting shoots, planted closely, pruned severely, and aligned to form a narrow fruiting wall (super slender axe, SSA), and 2) an oblique cordon-like horizontal leader with 7 to 10 upright fruiting mini-leaders aligned in a narrow fruiting wall canopy (upright fruiting offshoots, UFO). The rootstocks are ‘Gisela 3’ (Gi3, dwarfing), ‘Gisela 5’ (Gi5, semi-dwarfing), and ‘Gisela 6’ (Gi6, semi-vigorous). After 7 years, the Michigan trial (with the scion ‘Benton’) is the most vigorous trial site. Each canopy architecture has advantages and disadvantages with respect to precocious yields, cumulative yields, ease and cost of establishment, harvest labor, and potential for partial mechanization for pruning. Projected orchard yields have been highest for trees on the dwarfing and semi-dwarfing Gi3 and Gi5 rootstocks across all canopy architectures, and highest through 7 years on the UFO and TSA training systems. Fruit quality has not varied significantly by canopy architecture or rootstock. However, renewal of fruiting wood, one key to longevity of intensive orchards, has been problematic on some trees on the rootstocks that impart lower vigor and higher yields. These trials have contributed significant insights for improved orchard designs for the next generation of light- and labor-efficient canopy architectures for high quality sweet cherry production systems across a range of rootstock vigor traits.

Public randomization ceremonies have been proposed as a strategy to strengthen stakeholder engagement and address concerns and misconceptions associated with trial randomization. However, there are few published examples that describe how to conduct a public randomization ceremony with meaningful stakeholder engagement or how such ceremonies impact stakeholder perceptions about randomization and the randomization process. Cluster randomization for the GeneXpert Performance Evaluation for Linkage to Tuberculosis Care (XPEL-TB) trial was conducted at a public randomization ceremony attended by 70 stakeholders in Kampala, Uganda. Presentations given by the Acting Assistant Commissioner from the Uganda National Tuberculosis and Leprosy Programme and trial investigators emphasized how the trial aimed to further national TB goals, as well as how stakeholders contributed to the intervention design. The purpose and process of randomization were described using simple text and visuals. Randomization was an interactive activity that required participation of stakeholders from each trial site. A survey administered to stakeholders at the end of the ceremony suggested high comprehension of randomization (98%), trust in the randomization process (96%), and satisfaction with randomization outcomes (96%). Public randomization ceremonies should be considered more routinely to engage stakeholders in and address potential concerns about the fairness and impartiality of the randomization process for community-based trials.

Common bean is widely grown as a food legume and the post-harvest crop residues (CR) (i.e. haulm + pod wall (HPW)) are valuable as ruminant feedstuffs. The yields and constituents indicative of nutritive value for ruminants of the HPW from a wide range of common bean genotypes (G) were examined at 4 trial sites in Ethiopia during the 2013 main cropping season to assess the extent of genetic variation among G for simultaneous improvement of both HPW attributes and seed yield. Attributes measured were seed and HPW yields and the amounts of the morphological components, their concentrations of total nitrogen (N), neutral detergent fibre (aNDFom) and acid detergent fibre (ADFom), and the dry matter digestibility (DMD). The constituents were measured using near infrared spectroscopy (NIRS) and calibrations based on a large set of reference tropical forages and CR (including common bean), and were validated against other CR reference samples. These CR quality attributes were very well predicted with R2v and RPDv ranging from 0.90 to 0.98 and 3.13–7.36, respectively. There was considerable variation in yields of HPW and seed, and in the proportions and attributes of the HPW fractions among the common bean G. Trial site means for yields of HPW and seed ranged from 0.74 to 2.54 t/ha and 0.79–2.62 t/ha, respectively while for N, aNDFom and ADFom concentrations and DMD of HPW ranged from 7.7 to 11.4 g/kg DM, 648–739 g/kg DM, 502–585 g/kg DM, and 467–570 g/kg DM, respectively. Environment (E), as represented by site, generally affected the yields of HPW and seed (P

Virtual clinical trials (VCTs) can satisfy the need for rigorous clinical trials by using distributed technological solutions that eliminate the need for a physical trial site. This report explores potential benefits of using virtual reality (VR) to provide a “virtual site” for VCTs, a shared immersive hub in which VCT participants could experience elements of the trial and interact with the trial team. VR is a communication technology that has been emerging alongside the development of VCTs, although they have never been merged in a substantial way. Many of the gaps within the VCT paradigm are areas in which VR excels. VR environments are standardized and precisely uniform, the technology allows introduction of an almost endless set of stimuli to participants’ visual and auditory systems, and VR systems are adept at capturing precise movement and behavioral data. Although VR has not yet found its way into VCTs, much of the groundwork for such integration has been laid through research and technological development achieved in the past few years. Future implementation of VR within VCTs could move us from site-less trials to those with a virtual site serving as a hub for trial information provision, interaction with trial representatives, administration of evaluations and assessments, and more.

Clinical trials for investigational new products to treat rare and ultra-rare diseases typically involve a limited number of research sites recruiting from a small pool of patients dispersed over a large geographical area. When remote access is not possible and participants must be present at a trial site, participation in research may require individuals and their families/caregivers to travel great distances, often at significant cost personally and financially and, frequently, for the duration of the trial. This article addresses the ethical and practical issues associated with the practice of sponsors offering financial and other assistance for relocation to trial sites from significant geographical distances, providing both foundational analysis of the ethical issues as well as actionable policy-level guidance on how to best approach these situations.

Field trials were conducted in small-scale farmers' grain stores in an aflatoxin endemic region to assess the effect of storing maize in triple layer hermetic (PICS™) bags on aflatoxin contamination. Shelled maize grain was purchased from farmers, and filled into PICS bags, woven polypropylene (PP) and jute bags and kept in the farmers' own stores for 35 weeks. Grain moisture content, total mould count and mould incidence levels were examined at onset and after every 7 weeks during the 35 weeks of storage. Aflatoxin contamination was examined at onset, and after 14, 28 and 35 weeks. Ambient temperature and r.h. in the trial site and in all the bags, as well as oxygen and carbon dioxide levels in the PICS bags were also monitored. Initial moisture content (m.c.) of maize varied from farmer to farmer and ranged between 12.4 and 15.0%. The m.c. of maize stored in PICS bags remained significantly higher (P 14% increased profusely in the three types of bags. Our findings demonstrate that storing maize in PICS bags can prevent accumulation of aflatoxin in rural farmers' stores if grain moisture is

OBJECTIVE "Away Days" (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multicenter randomized controlled trials (RCTs). We explored the use of Away Days in multicenter RCTs and analyzed the effect on patient recruitment in a case study. METHODS Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multicenter pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. RESULTS A total of 94 people responded to the survey. The majority (78%), who confirmed had organized an Away Day previously, found them to be useful. This is despite their costs. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. CONCLUSIONS Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multicenter surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design, and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days.

Highlights • Cross-validation of analytical techniques for 1-hydroxypyrene and 2-naphthol. • Good agreement between low cost HPLC fluorescence (HPLC-FLD) and LC-MSMS methods. • HPLC-FLD method was highly sensitive to 2NAP compared to LC-MSMS. • HPLC-FLD showed large bias for 2NAP with LC-MSMS at levels greater than 20 ng/mL. • HPLC-FLD is a cost-effective and reliable analytical method for low-and middle-income countries., The Household Air Pollution Intervention Network (HAPIN) trial is evaluating health benefits of a liquefied petroleum gas (LPG) stove intervention in biomass cook-fuel using homes (n = 3200) in four low-and middle-income countries (LMICs) that include Peru, Guatemala, Rwanda and India. Longitudinal urine samples (n = 6000) collected from enrolled pregnant women, infants and older women will be analyzed for biomarkers associated with exposure and health outcomes. We report results from cross-validation of a lower cost high-performance liquid chromatography with fluorescence detection (HPLC-FLD) method with a higher resolution liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the measurement of 1-hydroxypyrene (1PYR) and 2-naphthol (2NAP). Twenty-five split urine samples were analyzed by HPLC-FLD method at the India trial site in Chennai, India and by LC-MSMS method at the trial wide Biomarker Coordinating Center, Emory University, USA. The limits of detection (LOD) for the HPLC-FLD method were 0.02 ng/mL and 0.07 ng/mL for 2NAP and 1PYR, respectively. Bland-Altman analysis estimated a bias of 2.98 ng/ml for 2NAP (95% CI: −5.22, −0.75) and 0.09 ng/mL for 1PYR (95% CI: −0.02, 0.21) with HPLC-FLD levels being lower than LC-MSMS levels at higher concentrations. Analyses of additional urine samples (n = 119) collected during the formative phase of the HAPIN trial in India, showed 2NAP and 1PYR levels to be consistently above the limit of quantification (LOQ) and demonstrated the applicability of the method. The HPLC-FLD method can serve as a cost-effective and reliable analytical method to measure 2NAP and 1PYR in human urine in LMICs, within and beyond the HAPIN trial.

This chapter describes the implementation phase of the project and the major challenges in deciding about relevant content, methods and procedures as well as methods of evaluation. The chapter describes some experiences and principles linked to enhancing communication in clinical settings. Various models of implementation are described including profession-specific models, team-training models and enhancing communication through performing arts. Case examples are offered for each, with a range of practical suggestions such as the use of drama techniques and evidence from a trial site and a paediatric clinic. A site-specific team-training model based on local contextual evidence is recommended, and some guidelines are offered for realistic measurement of the impact of such interventions on broader communication processes.

The National Disability Insurance Scheme (NDIS) is one of the most significant initiatives in Australian social policy history. Its complexity has been compounded by a fast-paced introduction and ongoing refinement throughout the initial trial phase. Parents and carers of very young disabled children face particular challenges accessing and navigating NDIS systems. This article presents findings from a mixed-method pilot study examining the perspectives of parents and carers of disabled children in one NDIS trial site – the Hunter Region of New South Wales. The research highlights a number of policy assumptions potentially impacting on NDIS take up for young disabled children and their families in regional contexts. Based on research findings a number of policy suggestions and improvements for disabled children and their families entering the NDIS and other individualised funding schemes are outlined.

Results of nine replicated provenance trials of silver birch (Betula pendula Roth) growing in Great Britain and Ireland are described. Five of the trials compare provenances from Scotland and the north of England measured after 10 or 11 years of growth; the remaining four trials compare provenances from across Great Britain, Ireland and the nearcontinent measured after 8 years of growth. In total, 64 provenances were tested. Survival was generally high across all sites with a mean of 79 per cent for the first five trials, and 89 per cent for the remaining four. The study found significant differences in mean height growth between trial sites and between provenances within each trial site. Although there was statistically significant site by provenance interaction, the better and poorer provenances were consistent across the range of sites tested. Mean height growth of the provenances under test was inversely correlated with latitude of origins, southern origins generally performing better. There was some evidence that further variation can be explained by incorporating details of longitude, accumulated temperature and potential moisture deficit for the origin. Elevation had little impact on explaining provenance performance. There was no evidence for the superior performance of provenances originating close to the trial site, other than for the southern-most trials. The relatively poor height growth of provenances from upland Scotland at even local trial sites suggests excessively conservative adaptation. The data suggest northern movement of provenances byat least 2 degrees latitude or 200 km would bring the benefits of improved height growth and yet carry little risk of poorer survival under current climate conditions and could perhaps be extended further according to predictions of future climate warming.

To investigate the effects of alcohol on the ability to ride a bicycle, practical cycling tests were carried out at different blood alcohol concentrations (BAC). For this purpose, various alcoholic beverages could be consumed from around 2 p.m. until 11 p.m. Afterwards, the test persons spent the night on the trial site and were provided with dormitory sleeping accommodation. On the following morning, beginning at around 8 a.m., a final cycling test was performed. The performances of those test persons who had returned to state of soberness and of those with residual blood alcohol levels were compared to the performances on the day before. The practical ability to ride a bicycle was significantly reduced in the postalcoholic state compared to the rides of the day before. The relative cycling performance in the postalcoholic state was comparable to the rides under the influence of BAC of around 0.30 g/kg. There were no remarkable differences between the groups with and without residual blood alcohol levels regarding the rides on the next morning. Therefore, it can be assumed that the direct influence of residual blood alcohol levels plays a minor role for the ability to ride a bicycle in the postalcoholic state. Instead, the side effects of the high amounts of alcohol that were consumed the night before are crucial.

Response of height growth of red pine (Pinus resinosa Ait.) to changes in climatic conditions was analyzed using data collected in a 48-year-old provenance trial established in northwestern Ontario, Canada. Seed sources for the trial were collected from 23 provenances spanning the natural range of red pine. Mean monthly values of climatic variables were estimated from historical climatic data for 1971 to 2000. Quadratic transfer functions predicting mean tree height at age 48 and tree top height at age 50 were developed using the difference in climatic variables between the seed source provenances and the trial site. The transfer function for mean height at age 48 explained 59% of data variation using the mean minimum temperature in July and sum of precipitation during June to February. For tree top height at age 50, the transfer function explained 55% of data variation using mean minimum temperature in January and sum of precipitation during June to March. The developed equations can be used to select op...

Three progeny trials of nyawai (Ficus variegata Blume) were established in Mangunan, Bantul, Yogyakarta. The trials were grouped in three sublines based on their original provenances: Lombok, Banyuwangi and Cilacap-Pangandaran. Each subline was laid out in Randomized Completely Block Design (RCBD) comprising 15-19 families.This study was aimed to observe growth variation and genetic parameter of the three sublines progeny trial at six and twelve months after planting. Analysis of variance was made to observe family effect for height and diameter, then the component of variance of each trait was used to estimate the heritability and genetic correlation. The results of study showed that at 12 months of age the survival rate of the trial was more than 90%, indicating high adaptability of the species to the trial site. Family effect on growth traits tended to increase as the trees getting older. Except for diameter in sub-line of Banyuwangi, estimation of individual heritabilities for height and diameter traits ranged from 0.015 to 0.241 and 0.017 to 0.096 respectively, with the corresponding for family heritabilities of height and diameter traits ranged from 0.09 to 0.434 and 0.123 to 0.352 respectively. It suggests that genetic control of the traits at both individual and family level were weak in the early growth. Genetic correlation between the two growth traits were varied among the sub-lines, indicating the character and growth pattern of nyawai seemed to be different among the sub-lines.

Recycled concrete aggregate (RCA) is often used as a pavement base or sub-base material. One unique concern of RCA used for such purposes is re-cementation. Although re-cementation increases the stiffness and bearing capacity of RCA, it may induce cracking if RCA becomes bound or partially bound. Four approaches were used in this study to investigate RCA re-cementation in pavement sub-base, including long-term monitoring of a trial site, test of RCA samples retrieved from the site, performance simulation based on mechanistic-empirical pavement design guide (ME-PDG), and numerical analysis. The trial site reveals that RCA becomes partially bound after 11 years of road use. The bound material exhibits properties similar to those of cement-treated base (CTB). However, due to variations in the content and composition of fines in RCA, the extent of re-cementation is not uniform in sub-base. According to the analysis results generated by ME-PDG, reflective cracking occurs if RCA is assumed to be CTB. Conversely, if bound RCA is non-monolithic, it may not have significantly negative effect on pavement performance. The fine content or composition of fines in RCA may be specified to further reduce the risk of RCA re-cementation.

An Audit is a “systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s SOPs, GCP, and the applicable regulatory requirements.” An Inspection is “an act by a Competent Authority of conducting an official review of documents, facilities, records and other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the trial site, at the sponsor and/or contract research organisation’s facilities or at other establishments deemed appropriate by the Regulatory Authority.” This chapter deals with preparation for audits and inspections.

Climate change is likely to significantly impact agricultural production in the Great Plains region of the Central United States. This study estimated the impact of changes in temperature and precipitation on wheat (triticum aestivum) variety yield distributions using the moment-based maximum entropy (MBME) model. This approach allows for quantification of potential weather impacts on the yield distribution, and allows these effects to vary across varieties. The unique data set matches wheat variety trial data for 1985 to 2011 with weather data from the exact trial site for 11 locations throughout Kansas. Ten widely-planted varieties with a range of biotic and abiotic characteristics were included for comparison. Weather scenarios were simulated for baseline, increased temperature (one-degree Celsius warming), decreased precipitation (tenth-percentile rainfall outcome), and a combination warming and drought scenario. Warming resulted in an 11 % yield reduction, drought a 22 % reduction, and warming and drought a cumulative 33 % reduction. These effects vary across varieties. Alternative measures of yield risk (e.g. yield variance and coefficient of variation) were also constructed under each scenario and a similar pattern of heterogeneous impacts emerges. The key findings are that (i) exposure to warming and drought lead to mean yield reductions coupled with increased yield risk for all varieties, and (ii) newer (post 2005) seed varieties have a yield advantage over older varieties, however this advantage is reduced under warming and drought conditions.

Aims Maintaining clinical trial screening logs and reporting data from such logs are given importance due to the relevance of a trial's patient population to the generalisability of its findings. However, screening logs may not always reflect a clinical trial's true target population. The aim of the present study was to define and compare ‘apparent recruitment' to a trial as captured in a clinical trial screening log with ‘true recruitment', which considers all potentially eligible patients. The Trans Tasman Radiation Oncology Group (TROG) 0803 RAVES clinical trial was used to examine the above. Materials and methods A prospective, surgical database was interrogated for the 12 month period to identify patients potentially eligible for the TROG 0803 RAVES trial. Information on whether patients were referred to a RAVES trial recruitment site and reasons for non-referral were obtained. Results Of 92 men undergoing radical prostatectomy, 28 met the RAVES clinical trial eligibility criteria. Fifteen of the 28 eligible men were assessed at a RAVES trial site, with five being ultimately recruited to RAVES (33% ‘apparent recruitment fraction' as captured by the site's trial screening log). The ‘true recruitment fraction' was 5/28 (18%). Conclusion Screening logs at a recruiting trial site may underestimate the trial's target population and overestimate recruitment. Only a subpopulation of all eligible patients may be captured in trial screening logs and subsequently reported on. This may affect the generalisability of the trial's reported findings.

Conducting clinical trials is costly and time consuming. Trial sites usually do not calculate site costs. Underestimating required resources slows enrollment and lowers data quality but it is currently unclear how to reliably estimate trial site costs. A group of trial staff designed and validated a tool for compiling trial tasks and calculating required expenditures prior to initiating a clinical trial. The tool was validated in two steps. Round-robin tests for accuracy compared case payments for the same trial calculated by different participants. A narrow CI was reached (22.95–715.69) demonstrating significantly similar estimates of the test participants (p = 0.039). To confirm the predictive value, the predicted and actual hours were compared and a correlation coefficient of 0.952 (p = 0.003) was found. A web-based tool, the Study Site Budgeting Tool, was developed, which allows trial sites to estimate staff costs at the site and determine the budget needed to conduct a clinical trial.

Aiming at the existing poor corrosion resistance, difficult transportation and construction of metal grounding material in transmission line grounding grid, this paper designed and prepared flexible graphite grounding materials based on carbon nanotubes modified technology. The performance of new grounding materials was analyzed and electrical performance experiments were carried out. The final trial site application example showed that the material can meet the practical engineering applications.

‘The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)’.

This study investigated the impact of organically grown cereals on the level of free asparagine (Asn) with simultaneous consideration of grain yields and flour qualities over three growing seasons in Germany. Additionally, the relation of free Asn and acrylamide (AA) was investigated. By including free Asn results of a second trial site, heritability of the trait free Asn was calculated. Free Asn was significantly influenced by species and within species by cultivars. Rye showed the highest free Asn amount, followed by einkorn, emmer, wheat, and spelt. Replacing rye with spelt would reduce free Asn by 85%. Cultivars differed in free Asn by up to 67% (wheat), 55% (spelt), and 33% (rye). Year significantly influenced free Asn levels. Heritability was high for wheat and spelt concerning locations, but regarding years, heritability was low for wheat but high for spelt and rye. For organically grown cereals, the relation between free Asn and AA formation has never been investigated. Across species and years, a correlation of R2 = 0.69 *** was found. Thus, free Asn can serve as an indicator for AA formation. In conclusion, the level of free Asn can be highly influenced by proper selection of species and cultivars.

The experimental area is located in the Węgorzyno Forest Sub-District, Łobez Forest District. 29 Polish provenances of beech from their natural range were growth in a completely randomised block design with four replications. In 2010, after the end of the growing season, measurements were carried out on the experimental plot, including: determination of the survival rate and the diameter at breast height, and height of trees. Moreover, the total basal area and the total volume were calculated. Using ANOVA, statistically significant differences between provenances were apparent for four of the five traits measured; all except diameter at breast height. Provenances characterised by high values for the analysed traits were considered the best adapted to the habitat conditions in the experimental plot, while provenances reaching low values were considered unsuitable for use under the conditions similar to those at the trial site location

Immunization remains the most cost effective method for the control of infectious diseases. Therefore, there is a global effort to deploy new vaccines for disease control and eradication. These new vaccines must be tested in the settings in which they will be used. This necessity has required the conduct of many vaccine trials in Africa, where several infectious diseases with significant public health impact are prevalent. However, these areas have peculiarities and are just beginning to gain expertise in the conduct of such trials. The vaccine developers and sponsors of these trials may also not be conversant with some issues unique to the trial site. The understanding gap from both partners can result in challenges if not addressed during the planning phase of the trial. This review seeks to highlight the issues surrounding the conduct of clinical trials in resource-constrained settings and suggests some ways of circumventing them.