Introduction The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel. Methods In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized. Results This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP. Conclusions We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.

Incoterms® define obligations, risks and costs that each of the seller and buyer must incur in the movement of the goods for a trade. New versions are issued when deemed necessary by the International Chamber of Commerce (ICC) and are aimed at including new trade realities and fostering trade. A new version Incoterms® 2020 is now available to replace the previous version, namely Incoterms® 2010. The research using Construct Clarity theory shows there are issues with the Incoterms® 2020 both as to the holistic ability to cover all trade as well as in the individual Incoterms® themselves. These issues are analysed in detail and, based on this research, the authors synthesize these into the reasoned aspects the Incoterms® drafting committee missed to further improve the Incoterms® rules. The authors extend this research and present the improvements that could be achieved in a future issue of the Incoterms® rules.

Bacterial infection of the tracheobronchial tree is a frequent, serious complication in patients receiving treatment with oxygen and mechanical ventilation, resulting in increased morbidity and mortality. Using human airway epithelial cell culture models, we examined the effect of hyperoxia on bacterial adherence and the expression of interleukin-8 (IL-8), an important mediator involved in the inflammatory process. A 24-h exposure to 95% O₂increased Pseudomonas aeruginosa (PA) adherence 57% in A549 cells ( P < 0.01) and 115% in 16HBE cells ( P < 0.01) but had little effect on Staphylococcus aureus (SA) adherence. Exposure to hyperoxia, followed by a 1-h incubation with SA, further enhanced PA adherence ( P < 0.01), suggesting that hyperoxia and SA colonization may enhance the susceptibility of lung epithelial cells to gram-negative infections. IL-8 expression was also increased in cells exposed to both hyperoxia and PA. Stable or transient overexpression of manganese superoxide dismutase reduced both basal and stimulated levels of PA adherence and IL-8 levels in response to exposure to either hyperoxia or PA. These data indicate that hyperoxia increases susceptibility to infection and that the pathways are mediated by reactive oxygen species. Therapeutic intervention strategies designed to prevent accumulation of intracellular reactive oxygen species may reduce opportunistic pulmonary infections.

Among the many sources of financial and operational risk in supply chains are the Incoterms^®, which are terms of trade used to decide who does what in a cargo movement, when risk passes from seller to buyer and who pays for which part of the movement. Wrong Incoterms^® create unexpected costs or risks, at best, and inoperable contracts at worst, with all the challenges implied. This paper analyzes risk in supply chain management (SCM) through the lens of the responsibilities and costs imposed by Incoterms^®. The authors also conducted a survey of 100 supply chain decision makers on supply chain contracts creation and Incoterms^® knowledge in the population. Failure mode and effect analysis (FMEA) of Incoterms^® reveals many scenarios that pose financial, operational, and even legal risk to firms. Results suggest Incoterms^® rules are poorly understood by supply chain practitioners in general, are often chosen by personnel who are not aware of the implications of their choices, and are therefore frequently chosen incorrectly or non-strategically, thereby increasing cost and risk. This paper discusses the implications of the analysis and survey results on supply chain performance as well as mitigation strategies for practitioners in strategically using Incoterms^® to remove cost, risk, and delay from supply chain transactions.

The rise of social media technology has led to new customer relationship management tools that engage customers more easily and directly (social customer relationship management, SCRM). However, the usefulness of SCRM is contingent upon a successful adoption by an organization. Various technology adoption theoretical frameworks have been proposed for social media technologies generally, and for SCRM specifically. This paper extends the literature by exploring network externalities as a potential driver of SCRM adoption in organizations by surveying 363 supply chain professionals regarding their behaviors and uses of SCRM. The results suggest that network externalities have a substantial effect on adoption of SCRM in business organizations and that a perception of higher network externalities has a positive effect on adoption. This implies that organizations should select SCRM systems with better network externalities and also that they should educate their workforce about those strong network externalities leading up to the adoption.

It has been well documented that genetic factors can influence predisposition to develop alcoholism. While the underlying genomic changes may be of several types, two of the most common and disease associated are copy number variations (CNVs) and sequence alterations of protein coding regions. The goal of this study was to identify CNVs and single-nucleotide polymorphisms that occur in gene coding regions that may play a role in influencing the risk of an individual developing alcoholism. Toward this end, two mouse strains were used that have been selectively bred based on their differential sensitivity to alcohol: the Inbred long sleep (ILS) and Inbred short sleep (ISS) mouse strains. Differences in initial response to alcohol have been linked to risk for alcoholism, and the ILS/ISS strains are used to investigate the genetics of initial sensitivity to alcohol. Array comparative genomic hybridization (arrayCGH) and exome sequencing were conducted to identify CNVs and gene coding sequence differences, respectively, between ILS and ISS mice. Mouse arrayCGH was performed using catalog Agilent 1 × 244 k mouse arrays. Subsequently, exome sequencing was carried out using an Illumina HiSeq 2000 instrument. ArrayCGH detected 74 CNVs that were strain-specific (38 ILS/36 ISS), including several ISS-specific deletions that contained genes implicated in brain function and neurotransmitter release. Among several interesting coding variations detected by exome sequencing was the gain of a premature stop codon in the alpha-amylase 2B (AMY2B) gene specifically in the ILS strain. In total, exome sequencing detected 2,597 and 1,768 strain-specific exonic gene variants in the ILS and ISS mice, respectively. This study represents the most comprehensive and detailed genomic comparison of ILS and ISS mouse strains to date. The two complementary genome-wide approaches identified strain-specific CNVs and gene coding sequence variations that should provide strong candidates to contribute to the alcohol-related phenotypic differences associated with these strains.