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Most of the prior studies concentrated on warning letters issued for clinical investigation, Institutional review board, and infringement of promotional claims, no studies assessed the warning letters issued for infringements of Current Good Manufacturing Practice (cGMP) pertaining to medical devices. Hence, there is a need to carry out a crosssectional study of these warning letters. Publically available U.S. Food & Drug Administration (USFDA) letters under the law of the freedom of Information Act sent to the pharmaceutical company were accessed from the USFDA website. A standard data collection tool (Excel Spreadsheet) with all letters of warning issued from January 2008 to July 2018 was developed. Letters have been manually screened. Warning letters related to medical device breaches of cGMP were screened based on the letter's subject and content. Overall, 669 warning letters issued for medical device cGMP violations were reviewed between January 2008 and November 2018. From 2008 to 2013, there was a downward trend in the issuance of warning letters. The number of warning letters issued in 2014 was 101, followed by 106 in 2015, as the USFDA focused more on data integrity issues, while the number decreased to 53, 27, and 19, respectively, in 2016, 2017, and 2018. The highest number of warning letters were issued to manufacturers located in the USA (379), followed by Canada (52), and China (37). Section 820.30 of Title 21 CFR was found to be most violated with 603 infringements. This section represents the design control requirements for cGMP. Class 2 type of medical devices were found to be most violated (82%), followed by Class 3 with 7%. Only 32% of the companies responded to the warning letters although 52% Not Issued the closeout letter followed by 16% of the letters were considered as non-applicable letters. With the time, scientific developments and increased awareness of both regulatory authorities and industries/academic organizations, overall improvement are observed with significant decrease in the number of warning letters.

Background: When implementing e-health solutions, effective integration into a clinic's existing processes is essential to facilitate adoption and sustained usage. Introduction: This article examines the effectiveness of adoption/utilization of an electronic consultation (eConsult) service by primary care providers (PCPs) using a "delegate model," through which referral clerks manage requests on behalf of PCPs, thereby reducing PCPs' administrative burden. Materials and Methods: We conducted a retrospective cross-sectional study of all eConsults submitted between May 1, 2013, and December 31, 2017, by the Bruyere Academic Family Health Team (FHT), after the clinic implemented the service using a delegate model. We assessed system utilization, including monthly volume of submitted eConsults, requested specialties, and impact on PCP referral behavior based on the mandatory closeout surveys. We also conducted a subanalysis to compare the volumes of eConsults per provider between the FHT and all other providers. Results: The Bruyere Academic FHT submitted 3,233 eConsult cases. Volume increased 3.5 fold, from 285 in the first year to 1,016 in the last year. Active Bruyere Academic FHT providers (those who submitted ≥3 cases in 6 months) submitted a median of 25 eConsults (interquartile range [IQR]: 14.75-35.25) versus 14 (IQR 8-24) for all other active users. In 36% of cases, a referral was originally contemplated but avoided based on specialist advice. In 5% of cases, the referral was not originally contemplated but deemed appropriate by the PCP based on specialist advice. Discussion: Our findings show high levels of eConsult use in the clinic utilizing a delegate model, which persisted throughout the study period and was reported to significantly reduce the backlog of traditional referrals at the clinic. Conclusions: The integration of eConsult capability into existing clinic operations was successful in that it allowed the PCPs to request eConsult using a familiar process, avoiding the challenges associated with adopting a new and unfamiliar technology.

Objective To compare the content of traditional faxed referrals and electronic consultations (eConsults) and determine how many questions sent by traditional referral could be successfully addressed using eConsult. Methods We conducted a cross-sectional, qualitative study of eConsults and faxed referrals sent to a tertiary diabetes and endocrinology clinic in Ottawa, Ontario. A convenience sample of 300 faxed referrals sent between March and July 2017 and 300 eConsults submitted between January and December 2017 were selected and coded using an established taxonomy to determine question type. Two endocrinologists reviewed the faxed referrals to assess whether they could have been addressed using eConsult. Responses to a mandatory closeout survey were reviewed for all eConsults, assessing the case’s outcome, impact on decision to refer, and educational value. Results Most faxed consultations were requests for shared care in diabetes mellitus, whereas most eConsults requested help in diagnostic test interpretation. 25–27% of faxed consults were felt to be potentially amenable to eConsult. Referring provider behaviour was changed in 45.3% of eConsult cases through avoidance of face-to-face consultation. Conclusion eConsult is a promising tool for PCPs to improve access to specialist opinion without necessitating a face-to-face visit.

In this paper, we launch a practical modus-operandi for the assessment of potential market risk exposures for financial trading portfolios by providing an investment management perspective from the 2007-2009 global financial crisis. This proposed tactic is based on the renowned concept of Liquidity-Adjusted Value-at-Risk (LVaR) along with the innovation of a risk-engine algorithm that can estimate LVaR for both long and short-sales positions.

Auction is probably the most seasoned method of purchasing and selling merchandise and items. The present world has been changed to the web so closeout has additionally advanced to online.83% of the absolute populace purchase something in the auction.94% of the all-out populace sell items in the bartering. 34% of the complete populace determines the status of the sale. This two-way component is utilized for purchasing and selling items or IAAS. The Internet gave an unbounded commercial center to clients, one in which they can discover anything they need and think about costs without any problem. Distributed computing is the transport of figuring administrations including workers, limit, information bases, coordinating, PC program, examination, and insight over the Web ("the cloud") to offer speedier turn of events, versatile resources, and economies of scale. You usually pay in a manner of speaking for cloud organizations you use, having an effect lower you're working expenses, run your structure all the more capably, and scale your trade needs changes.

This article investigates the applicability and compatibility of project closeout processes defined in traditional project management frameworks in cases of agile-developed IT projects. Based on a literature review analysis of three project management frameworks, the hypothesis is formed that traditional project closeout processes are critical in agile developed IT projects. The developed hypothesis suggests an unclear indication of how to trigger a project closeout, the inapplicability of scope fulfillment for closeout trigger, and critical transitions between closed projects and ongoing agile software improvement and maintenance. All three parts of the hypothesis are then individually evaluated by an online survey with 85 participants. As a result of this survey, all three hypotheses are falsified. For most project management practitioners in agile projects, closeout processes are not critical, scope fulfillment is still the most relevant closeout trigger, and the transition to a continues-improvement and maintenance process is seen as principally uncritical.

Background: Research site monitoring (RSM) is an effective way to ensure compliance with Good Clinical Practice (GCP). However, RSM is not offered to trainees (investigators) at African Institutions routinely. The Makerere University/Uganda Virus Research Institute Centre of Excellence in Infection and Immunity Research and Training (MUII-Plus) introduced internal monitoring to promote the quality of trainees’ research projects. Here, we share our monitoring model, experiences and achievements, and challenges encountered. Methods: We analysed investigators’ project reports from monitoring visits undertaken from April 2017 to December 2019. Monitors followed a standard checklist to review investigator site files and record forms, and toured site facilities. We planned four monitoring visits for each trainee: one at site initiation, two interim, and a closeout monitoring visit. A team of two monitors conducted the visits. Results: We monitored 25 out of the 26 research projects in progress between April 2017 and December 2019. Compliance with protocols, standard operating procedures, GCP, and GCLP improved with each monitoring visit. Median (IQR) compliance rate was 43% (31%, 44%) at site initiation visit for different monitoring items, 70% (54%, 90%) at the 1st interim monitoring visit, 100% (92%, 100%) at 2nd interim monitoring visit and all projects achieved 100% compliance at site closeout. All investigators had good work ethics and practice, and appropriate facilities. Initially, some investigators’ files lacked essential documents, and informed consent processes needed to be improved. We realized that non-compliant investigators had not received prior training in GCP/GCLP, so we offered them this training. Conclusions: Routine monitoring helps identify non-compliance early and improves the quality of research. We recommend continuous internal monitoring for all research studies. Investigators conducting research involving human subjects should receive GCP/GCLP training before commencing their projects. Institutional higher degrees and research ethics committees should enforce this as a requirement for project approvals.

In the recent times, the World Wide web has the drastic effect on the way people used to do the business in a standard way. Individuals can financial institution, oversee ventures, demand various items, and acquire information on an unbounded variety of points on the internet. It is not a good sign that, such a boost to the technique is not contributing to the development and prosperity of the new entrepreneur. It is also disappointing that the pharmacy business failed to take gain of this fortunate ruin to modernize a standard limit —prescription agreement. Various web drug stores provide medium-term delivery, enabling customers to hold a strategic distance from the deferral of regular mail. Web medicate stores can offer protection that is regularly ailing in a standard drug store. In any case, there is need to consider fundamentally the moral standards in the usage of digital drug. The online medical stores has induced administrative and checking activities at the government, and expert affiliation stages. The closeout of e-medicines in the global framework is possibly perilous and needs universal guidelines. Here is an outline of online drug stores, their latent advantages, the affiliations engaged with controlling these destinations, and the enormous discussions including on the web drug stores.

Closeout procedures enable central counterparties (CCPs) to respond to events that challenge the continuity of their normal operations, most frequently triggered by the default of one or more clearing members. The procedures ensure the regularity of the settlement process through the prudent and orderly closeout of the defaulter’s portfolio. Traditional approaches to CCPs’ margin requirements typically assume a simple closeout profile, and do not account for the ‘real-life’ constraints embedded on the management of a default. The paper proposes an approach of evaluating how distinct closeout strategies may expose a CCP to different sets of risk and costs, and consequently could impact the sufficiency of financial resources to cover its risk exposure to a default. The approach is based on a counterfactual simulation, and evaluates a full spectrum of hedging strategies in an exploratory and model-free manner, deriving endogenous and market-dependent risk metrics. Using the trade repository data available to the Bank (as a result of EMIR reporting) on over-the-counter (OTC) interest rate swaps (IRS) and ten years (ie 2005 to 2015) of information on related market risk factors, the paper derives empirically an efficient hedging strategy that minimizes the CCP’s risk exposure to a defaulting clearing member. Endogenous trade-off structures between total risk (market risk plus funding needs) and transaction costs are also established, with marginal sensitivities to individual components of the hedging strategy determined.

To apply final as-built BIM models to facility management (FM) during the operation phase, it is important for owners to obtain an accurate, final as-built model from the general contractors (GCs) following project closeout. Confirming the accuracy of the final as-built BIM model is one of the most important works executed by owners to meet the accuracy requirement of final as-built models for FM. However, many practical problems arise relating to the management of final as-built models such as final as-built model mismatch, the lack of available final as-built models, and the entry of incorrect non-geometric information into the final as-built models. To solve these practical problems, this study develops a Final As-built BIM Model Management (FABMM) system for owners to handle final as-built BIM model inspection, modification, and confirmation (BMIMC) work beyond project closeout. The proposed approach and system can be used to manage the status and results of BMIMC management work for the final as-built BIM model to be performed. The proposed approach and system were applied in a case study in a selected building in Taiwan to verify and demonstrate its practical effectiveness. This study identifies the benefits, limitations, and conclusions of the FABMM system, and presents suggestions for its further application.

Purpose Problems of Malaysian construction industry have often been associated, in part to incompetent construction manager (CM) when managing the construction projects. Although various education and training provisions have been introduced, critics argue that the provisions have not been effective. Central in the debate on the adequacy of the CM education and training offered is the answer to the question of “what constitutes the technical competency of the CM?” The purpose of this paper is to present the study that identifies the technical competencies required by the CM to address the question. Design/methodology/approach Multi-layered thematic analysis of literature was first carried out to identify the technical competency elements. Then, interviews were undertaken to confirm the elements of competencies. It was followed with questionnaire surveys to test the validity of the technical competencies against different contractors’ category and grade/size. Findings The findings suggest that the technical competencies of CM are generic, regardless of the size of construction organisation or the types of projects they undertake. A total of 16 CM technical competencies were identified which include the ability to manage: staff, materials, labour, plant, sub-contractors, safety, money, quality, time, environment, site administration, pre-construction activities, project closeout and handover, third parties, computer literacy, and construction contract. Originality/value The findings suggest that generic education and training is possible to develop technically competent CM. It also provides insights to the CM technical competencies which the industry is expecting.

Purpose The purpose of this paper is to provide an analysis of a post-project review (PPR) method designed to verify the accomplishments of urban disaster risk reduction-neighborhood approach (DRR-NA) projects after at least one year of project closeout. The PPR revisited the essential processes identified during project implementation and analyzed the sustainability of project gains. Design/methodology/approach The first section focuses on a literature review of the evaluation methods after project implementation, and the second describes the urban risk PPR design, its implementation, and findings. Findings The proposed framework for the PPR was clear and uniform and at the same time offered the necessary flexibility to adapt to the different DRR-NA projects and contexts. The PPR methodology sought to determine the conditions of the physical works, social and environmental gains, and progress in institutional arrangements associated with the NA projects. Factors that contribute and impede success in DRR-NA projects were identified. Practical implications Allowing at least one year between the completion of the NA projects and the PPR is both convenient and challenging. On the positive side, this approach allows for the verification of project outcomes after an extended period of time. However, there are also challenges, such as the need to seek additional financial resources to carry out the review; generate new contractual mechanisms; and assign human resources to review a project already closed. Originality/value The changes introduced into the PPR methodology to obtain a participative and self-conducted process resulted in a truly collective learning experience, becoming an act of accountability and social commitment.

Summary Identifying biomarkers as surrogates for clinical endpoints in randomized vaccine trials is useful for reducing study duration and costs, relieving participants of unnecessary discomfort, and understanding vaccine-effect mechanism. In this article, we use risk models with multiple vaccine-induced immune response biomarkers to measure the causal association between a vaccine’s effects on these biomarkers and that on the clinical endpoint. In this setup, our main objective is to combine and select markers with high surrogacy from a list of many candidate markers, allowing us to get a more parsimonious model which can potentially increase the predictive quality of the true markers. To address the missing “potential” biomarker value if a subject receives placebo, we utilize the baseline immunogenicity predictor design augmented with a “closeout placebo vaccination” group. We then impute the missing potential marker values and conduct marker selection through a stepwise resampling and imputation method called stability selection. We test our proposed strategy under relevant simulation settings and on (partially simulated) biomarker data from a HIV vaccine trial (RV144).

Background Fever is an important vital sign and often the first one to be assessed in a sick child. In acutely ill children, caregivers are expected to monitor a child’s body temperature at home after an initial medical consult. Fever literacy of many caregivers is known to be poor, leading to fever phobia. In children with a serious illness, the responsibility of periodically monitoring temperature can add substantially to the already stressful experience of caring for a sick child. Objective The objective of this pilot study was to assess the feasibility of using the iThermonitor, an automated temperature measurement device, for continuous temperature monitoring in postoperative and postchemotherapy pediatric patients. Methods We recruited 25 patient-caregiver dyads from the Pediatric Surgery Department at the Massachusetts General Hospital (MGH) and the Pediatric Cancer Centers at the MGH and the Dana Farber Cancer Institute. Enrolled dyads were asked to use the iThermonitor device for continuous temperature monitoring over a 2-week period. Surveys were administered to caregivers at enrollment and at study closeout. Caregivers were also asked to complete a daily event-monitoring log. The Generalized Anxiety Disorder-7 item questionnaire was also used to assess caregiver anxiety at enrollment and closeout. Results Overall, 19 participant dyads completed the study. All 19 caregivers reported to have viewed temperature data on the study-provided iPad tablet at least once per day, and more than a third caregivers did so six or more times per day. Of all participants, 74% (14/19) reported experiencing an out-of-range temperature alert at least once during the study. Majority of caregivers reported that it was easy to learn how to use the device and that they felt confident about monitoring their child’s temperature with it. Only 21% (4/9) of caregivers reported concurrently using a device other than the iThermonitor to monitor their child’s temperature during the study. Continuous temperature monitoring was not associated with an increase in caregiver anxiety. Conclusions The study results reveal that the iThermonitor is a highly feasible and easy-to-use device for continuous temperature monitoring in pediatric oncology and surgery patients. Trial Registration ClinicalTrials.gov NCT02410252; https://clinicaltrials.gov/ct2/show/NCT02410252 (Archived by WebCite at http://www.webcitation.org/73LnO7hel)

Social processes that change quickly are difficult to study, because they require frequent survey measurement. Weekly, daily, or even hourly measurement may be needed depending on the topic. With more frequent measurement comes the prospect of more complex patterns of missing data. The mechanisms creating the missing data may be varied, ranging from technical issues such as lack of an Internet connection to refusal to complete a requested survey. We examine one approach to mitigating the damage of these missing data - a follow-up or closeout interview that is completed after the frequent measurement. The Relationship Dynamics and Social Life (RDSL) study used this approach. The study asked women weekly about their attitudes and behaviors related to sexual relationships and pregnancy. The surveys were carried out for 130 weeks and concluded with a closeout interview. We explore the patterns of missing data in the RDSL study and then examine associations between the data collected in the closeout survey and key variables collected in the weekly survey. We then assess the extent to which data from the closeout survey are useful in repairing the damage caused by missing data.

This chapter provides regulatory guidance and author insight on how study teams can correctly and efficiently conclude a trial, ensuring regulatory compliance as well as positioning the site for attracting future sponsor and research funding. The chapter provides detailed information on study closeout procedures, including important International Council on Harmonisation Good Clinical Practices (ICH GCP) guidance on Essential Document Retention following the clinical study conclusion. The chapter concludes with recommendations on the procedures for publishing the results of a clinical trial.

The HALT Polycystic Kidney Disease Trials Network consisted of two randomized, double blind, placebo-controlled trials among patients with autosomal dominant polycystic kidney disease. The trials involved 5-8years of participant follow-up with interventions in blood pressure and antihypertensive therapy. We provide a framework for designing and implementing closeout near the end of a trial while ensuring patient safety and maintaining scientific rigor and study morale.We discuss issues and resolutions for determining the last visit, tapering medications, and unblinding of participants to study allocation and results. We also discuss closure of clinical sites and Data Coordinating Center responsibilities to ensure timely release of study results and meeting the requirements of regulatory and funding authorities.Just over 90% of full participants had a 6-month study visit prior to their last visit preparing them for trial closeout. Nearly all patients wanted notification of study results (99%) and treatment allocation (99%). All participants were safely tapered off study and open label blood pressure medications. Within 6months, the trials were closed, primary papers published, and 805 letters distributed to participants with results and allocation. DCC obligations for data repository and clinicaltrials.gov reporting were completed within 12months of the last study visit.Closeout of our trials involved years of planning and significant human and financial resources. We provide questions for investigators to consider when planning closeout of their trials with focus on (1) patient safety, (2) dissemination of study results and (3) compliance with regulatory and funding responsibilities.

Multi-asset class, multimarket central counterparties (CCPs) are becoming less uncommon as a result of merges between specialized (single-asset class, single market) CCPs and market demands for greater capital efficiency. Yet, traditional CCP risk management models often lack the necessary sophistication to estimate potential losses relative to the closeout process of a defaulter’s portfolio in a multi-asset class, multimarket environment. As a result, multi-asset class, multimarket CCPs usually rely on a simplified silo approach for risk calculation which not only fails to deliver efficiency, but may also increase systemic risk. The CORE (Closeout Risk Evaluation) approach, on the other hand, provides conceptual and mathematical tools necessary for robust and efficient central counterparty risk evaluation in multi-asset class and multimarket environments, acknowledging the portfolio dynamics involved in the closeout process as well as important “real life” market frictions.

The endocrinology eConsult service at Mount Sinai Hospital, in New York City, was conceived to simplify and accelerate access to the expertise of endocrinologists. Here we detail how we designed our workflow according to input from primary care providers (PCPs). Additionally, we describe the impact of the pilot phase of our endocrinology eConsult service. In this pilot phase, providers in a Medicaid clinic and those making visits to homebound patients placed eConsult orders within the hospital's EMR using one of 18 original, disease-specific templates and one generic template. The eConsultant sent evidence-based recommendations in a response template, which included a rationale with references. As part of an ongoing quality improvement project, PCPs were asked to complete a two question closeout survey. Seventy percent of PCPs indicated that they got good advice for a new or additional course of action, and 25% answered that they were able to confirm a course of action that they already had in mind. Referral was originally contemplated, but avoided as a result of the eConsult according to 62% of respondents, exceeding rates reported at other academic institutions. Our unique emphasis on providing a detailed rationale for recommendations may have contributed to these outcomes. With a majority of respondents indicating that a formal consultation was averted, an expanded endocrine eConsult service could reduce a significant volume of unnecessary endocrine referrals, expedite more urgent visits, and reduce costs. This outcome is especially significant in light of a nationwide shortage of endocrinologists.

Due to financial crisis many entrepreneurs suffered heavy losses on derivatives, mainly currency options and forward contracts. Tax authorities tend to disallow deduction of those losses from the taxable income. Many cases ended up in administrative courts, resulting in judicature controversies on the issue in question. This paper is the third of four in a cycle. The aim of the whole cycle will be to analyze deeply these controversies and suggest the proper interpretation of the legal provisions, determining whether the expenses on currency options and forward contracts should or should not be regarded as tax-deductible expenses. The aim of this paper is to determine if the rights from the derivatives are being exercised or waived (as the law provides) in case of their early closeout (which allows the deduction as well). The conducted analysis suggests that early derivative closeout realises in exercising the rights from the derivative (as the law provides) which allows the deduction.

Background Since 2010, the Champlain BASE (Building Access to Specialist Advice through eConsultation) has allowed primary care providers (PCPs) to submit clinical questions to specialists through a secure web service. The study objectives are to describe questions asked to Infectious Diseases specialists through eConsultation and assess impact on physician behaviors. Methods eConsults completed through the Champlain BASE service from April 15, 2013 to January 29, 2015 were characterized by the type of question asked and infectious disease content. Usage data and PCP responses to a closeout survey were analyzed to determine eConsult response time, change in referral plans, and change in planned course of action. Results Of the 224 infectious diseases eConsults, the most common question types were as follows: interpretation of a clinical test 18.0% (41), general management 16.5 % (37), and indications/goals of treating a particular condition 16.5% (37). The most frequently consulted infectious diseases were as follows: tuberculosis 14.3% (32), Lyme disease 14.3% (32), and parasitology 12.9% (29). Within 24 hours, 63% of cases responded to the questions, and 82% of cases took under 15 minutes to complete. In 32% of cases, a face-to-face referral was originally planned by the PCP but was no longer needed. In 8% of cases, the PCP referred the patient despite originally not planning to make a referral. In 55% of cases, the PCP either received new information or changed their course of action. Conclusions An eConsult service provides PCPs with timely access to infectious disease specialists’ advice that often results in a change in plans for a face-to-face referral.

Display of stock plays an effective role to boost up the demand as it encourages customer to buy more. For perishable good freshness is also an important factor affecting its demand, as consumers look for fresh items. Selling price is also a major factor affecting the demand. This paper proposes an inventory model where demand depends on selling price, freshness of item and displayed stock. The traditional assumption of zero ending inventories is relaxed to a non-zero ending inventory. As it may be profitable to have a closeout sale at a markdown price, and always keep on-hand fresh displayed stocks if the demand is freshness-and- stock dependent. The objective is to maximize the total profit with respect to three decision variables (i.e., unit price, cycle time and ending-inventory level). Numerical examples are presented to validate the model and sensitivity analysis of inventory parameters is done to understand their effect in determining optimal policies.

Introduction: Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is less frequent, may be more complex, and may require added flexibility in closure methods, including short term follow-up. VOLUME was a randomized, open-label, post-approval pragmatic clinical trial (PCT) or large simple trial that terminated early due to product withdrawal. The aim of this paper is to describe circumstances unique to post-approval PCTs that may require a closure amendment rather than immediate study termination, and our recommendations for operational study closure in these circumstances. We use the VOLUME case study throughout to provide a practical example. Methods: Study closeout considerations at the study level include: notifying external governance bodies, e.g., data monitoring committees (DMC), and scientific steering committees (SSC); executing a study closure amendment; notifying and training of study physicians; and institutional review board (IRB)/ethics committee (EC) approvals. Study closure considerations at the patient level focus on patient safety and include: patient notification, efficient transition to alternative treatments, the need for re-consenting; and drug supply shortages. Conclusions: Early study closeout logistics require careful analysis, detailed planning, and close coordination, and are ideally considered at the study planning phase. Lessons learned from the VOLUME closeout should help other researchers devise contingencies when terminating post approval pragmatic trials that utilize a marketed product.ClinicalTrials.gov: NCT00359801. Keywords: Large simple trial, Closure, Product withdrawal, Commercial withdrawal, Pragmatic

BACKGROUND In 2005 through 2009, the Centers for Disease Control and Prevention (CDC) funded 5 sites to implement a colorectal cancer screening program for uninsured, low-income populations. These 5 sites composed a demonstration project intended to explore the feasibility of establishing a national colorectal cancer screening program through various service delivery models. METHODS A longitudinal, multiple case study was conducted to understand and document program implementation processes. Using metaphor as a qualitative analytic technique, evaluators identified stages of maturation across the programmatic life cycle. RESULTS Analysis rendered a working theory of program development during screening implementation. In early stages, program staff built relationships with CDC and local partners around screening readiness, faced real-world challenges putting program policies into practice, revised initial program designs, and developed new professional skills. Midterm implementation was defined by establishing program cohesiveness and expanding programmatic reach. In later stages of implementation, staff focused on sustainability and formal program closeout, which prompted reflection about personal and programmatic accomplishments. CONCLUSIONS Demonstration sites evolved through common developmental stages during screening implementation. Findings elucidate ways to target technical assistance to more efficiently move programs along their maturation trajectory. In practical terms, the time and cost associated with guiding a program to maturity may be potentially shortened to maximize return on investment for both organizations and clients receiving service benefits. Cancer 2013;119(15 suppl):2926–39. © 2013 American Cancer Society.

Achieving clinical trial research participant enrolment is clearly essential to conducting a successful trial. Adequate enrolment provides a basis for projected participant retention, resulting in evaluative patient data. Without sufficient patient retention from the time of study initiation to closeout, the number of remaining participants may prove to be too small a pool from which to derive conclusive proof or disproof of the goal of the clinical trial sponsor. Obtaining final evaluative data is dependent on successful patient retention. Patients cannot be retained without an initial pool of enrolled volunteers. This initial pool of screened, then enrolled, participants depends on designing a successful patient recruitment strategy. ‘A major focus in all clinical trials is on the recruitment of subjects. Where and how to do this depends on the demographics of the target population and the condition under investigation’. [1, 2].

To describe the impact of an eConsult service on access to endocrinologists along with its influence on changing primary care provider (PCP) course of action and referral behaviors.Established in 2011, the Champlain BASE (Building Access to Specialist Care via eConsult) service allows PCPs to access specialist care in lieu of traditional face-to-face referrals. We conducted a cross-sectional study of eConsult cases submitted to endocrinologists by PCPs between April 15, 2011 and January 31, 2015. Usage data and PCP responses to a mandatory closeout survey were analyzed to determine eConsult response times, PCP practice behavior, referral outcomes, and provider satisfaction. Each eConsult was coded according to clinical topic and question type based on established taxonomies.A total of 180 PCPs submitted 464 eConsults to endocrinology during the study period. Specialist median response time was 7 hours, with 90% of responses occurring within 3 days. PCPs received a new or additional course of action in 62% of submitted cases. An unnecessary face-to-face referral was avoided in 44% of all eConsults and in 67% of cases where the PCP initially contemplated requesting a referral. Over 95% of cases were rated at least 4 out of 5 in value for PCPs and their patients.The use of eConsult improves access to endocrinologists by providing timely, highly rated practice-changing clinical advice while reducing the need for patients to attend face-to-face office visits.BASE = Building Access to Specialist Advice through eConsult PCP = primary care physician UCSF = University of California San Francisco.

Objective. To describe the impact of the Champlain BASE (Building Access to Specialists through eConsultation) eConsult service on access to specialist care for patients with chronic pain. Design. A cross-sectional descriptive study Setting. The Champlain Local Health Integration Network, comprising Ottawa, Canada, and the surrounding region. Subjects. All eConsult cases submitted to chronic pain specialists by primary care providers between April 15, 2011 and June 30, 2015. Methods. Usage data and provider responses to a mandatory closeout survey were analyzed to determine response times, case outcomes, and provider satisfaction. Results. Ninety-three primary care providers submitted 199 eConsults to four chronic pain specialists during the study period. Submitted cases had median response times of 1.9 days. Thirty-six percent of cases resulted in an unnecessary referral being avoided, and over 90% of cases were rated by primary care providers as being of high or very high value for their patients and themselves. Conclusion. The eConsult service improved access to specialist care for patients with chronic diseases. By facilitating prompt communication between primary care providers and specialists, eConsult can help mitigate the negative effects of long wait times experienced by patients with chronic pain.

Government defense contractors are burdened by contracts which have ended, but have not been finalized and closed. In order to keep good relations with organizations regulating government contracts, contractors have been forced to devise a strategy to address contract closeouts. Data was collected about a defense contractor’s contract closeout process, and a simulation model of the system was developed to aid in completing the contract closeout process. Using simulation software, the closeout process was successfully modeled under varying resource levels. The simulation model included true worker process times with integrated schedules, including holidays, over the expected period of performance. The simulation produced a realistic model which allows an organization to plan their resources to accomplish their contract closeout process under specified conditions and deadlines. The results are relevant to government (public sector) contracts as well as industrial (private sector) contracts where similar regulations are applicable.

Although design-build/engineer, procure, construct EPC contracting can potentially save millions of dollars up front, as well as dollars paid in change orders while construction proceeds, design-build/EPC contracting may not be the silver bullet for construction that design-build/EPC contractors perceive it to be. Owners often question whether the checks and balances are in place and question who really pays for alterations in design. Owners look toward the design-build/EPC contractor to be the onestop shop and the last stop for all the costs to be incurred for a project—from inception to project closeout. Thus, change becomes an issue that may not be well defined in today’s designbuild/EPC construction environment.

Current ethics and good clinical practice guidelines address various aspects of pharmaceutical research and development, but do not comprehensively address the bioethical responsibilities of sponsors. To fill this void, in 2010 Eli Lilly and Company developed and implemented a Bioethics Framework for Human Biomedical Research to guide ethical decisions. (See our companion article that describes how the framework was developed and implemented and provides a critique of its usefulness and limitations.) This paper presents the actual framework that serves as a company resource for employee education and bioethics deliberations. The framework consists of four basic ethical principles and 13 essential elements for ethical human biomedical research and resides within the context of our company's mission, vision and values. For each component of the framework, we provide a high-level overview followed by a detailed description with cross-references to relevant well regarded guidance documents. The principles and guidance described should be familiar to those acquainted with research ethics. Therefore the novelty of the framework lies not in the foundational concepts presented as much as the attempt to specify and compile a sponsor's bioethical responsibilities to multiple stakeholders into one resource. When such a framework is employed, it can serve as a bioethical foundation to inform decisions and actions throughout clinical planning, trial design, study implementation and closeout, as well as to inform company positions on bioethical issues. The framework is, therefore, a useful tool for translating ethical aspirations into action - to help ensure pharmaceutical human biomedical research is conducted in a manner that aligns with consensus ethics principles, as well as a sponsor's core values.

Sprint is one of the telecommunications industry leaders in the deployment of hydrogen fuel cell (HFC) systems to provide backup power for their mission critical wireless network facilities. With several hundred fuel cells commissioned in California, states in the gulf coast region, and along the upper eastern seaboard. A strong incentive for advancing the integration of fuel cells into the Sprint network came through the award of a Department of Energy (DOE) grant focused on Market Transformation activities for project (EE0000486). This grant was funded by the 2009 American Recovery and Reinvestment Act (ARRA). The funding provided by DOE ($7.295M) was allocated to support the installation of 260 new HFC systems, equipped with an on-site refillable Medium Pressure Hydrogen Storage Solution (MPHSS), as well as for the conversion of 21 low pressure hydrogen systems to the MPHSS, in hopes of reducing barriers to market acceptance.