Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements

JAMA ◽  
2021 ◽  
Author(s):  
Reshma Ramachandran ◽  
Christopher J. Morten ◽  
Joseph S. Ross
Keyword(s):  
Reporting Requirements

Enriching AIS Courses With SOX Compliance Activities

2010 ◽  
Vol 5 (1) ◽  
pp. 1-24 ◽  
Author(s):  
Joann Segovia ◽  
Carol M. Jessup ◽  
Marsha Weber ◽  
Sheri Erickson
Keyword(s):  
Corporate Governance ◽  
Financial Reporting ◽  
Internal Controls ◽  
Accounting Profession ◽  
Investor Confidence ◽  
Reporting Requirements ◽  
Sarbanes Oxley ◽  
Audit Firms ◽  
Significant Change

A very significant change to the accounting profession occurred in 2002 when the Sarbanes-Oxley Act of 2002 (SOX) was enacted. This legislation had a significant impact on corporations and their audit firms. The objective was to improve corporate governance and its quality of financial reporting to improve investor confidence. This paper provides instructors with a background on SOX and suggests readings and activities that reflect the requirements of SOX as it relates to the AIS environment and the analysis of internal controls. These activities can strengthen students' understandings of how corporations respond to the various reporting requirements of this Act.

An Analysis of Segment Disclosures under SFAS No. 131 and SFAS No. 14

2000 ◽  
Vol 14 (3) ◽  
pp. 287-302 ◽  
Author(s):  
Don Herrmann ◽  
Wayne B. Thomas
Keyword(s):  
Decision Making ◽  
Geographic Area ◽  
Segment Reporting ◽  
Internal Organization ◽  
Country Level ◽  
Reporting Requirements ◽  
Geographic Segment Disclosures ◽  
Segment Disclosures ◽  
Number Of Firms ◽  
Segment Information

The purpose of this paper is to compare the segment reporting disclosures under SFAS No. 131 with those reported the previous year under SFAS No. 14. Under SFAS No. 131, firms are required to report segments consistent with the way in which management organizes the business internally. In addition, the accounting items disclosed for each segment are defined consistent with internal segment information used to assess segment performance. For many companies, this represents a significant change from the approach used to report segments under SFAS No. 14. Under SFAS No. 14, firms were required to disclose segment information by both line-of-business and geographic area with no specific link to the internal organization of the company or the measurements that were used for internal decision making. As a result, many complained that the resulting disclosures were highly aggregated and of limited use for decision-making purposes. We find that the change in segment reporting requirements under SFAS No. 131 has made a relatively significant impact on the disclosure of segment information. Over two-thirds of the sample firms have redefined their primary operating segments upon adopting SFAS No. 131. There has also been an increase in the number of firms providing segment disclosures and companies are disclosing more items for each operating segment. For enterprise-wide disclosures, the proportion of country-level geographic segment disclosures has increased, while the proportion of broader geographic area segment disclosures has decreased. However, the number of firms reporting earnings by geographic area has declined greatly as this item is no longer required to be disclosed for firms reporting on a basis other than geographic area.

Company Law

2018 ◽  
Author(s):  
Simon Butt ◽  
Tim Lindsey
Keyword(s):  
Corporate Governance ◽  
Corporate Social Responsibility ◽  
Mergers And Acquisitions ◽  
Foreign Investment ◽  
Corporate Crime ◽  
Codes Of Conduct ◽  
Company Law ◽  
Reporting Requirements ◽  
Governance Regime ◽  
Corporate Social

This chapter deals with the law regulating business vehicles in Indonesia. The principal focus of the chapter is companies (including publicly listed companies, foreign investment, and shari’a companies) but it also covers partnerships, cooperatives, and state-owned enterprises, as well as the different regulations that apply to each. It explains the rules governing shares and capital, and directors and commissioners, as well shareholders’ rights, including in relation to general meetings. The rules for mergers and acquisitions are covered, as are corporate audit and reporting requirements. The chapter then summarizes the corporate governance regime applied in Indonesia through a mix of legislative provisions, codes of conduct, and other rules, including corporate social responsibility obligations. It also explains Indonesia’s corporate crime regime.

scholarly journals Automated Extraction and Time-Cost Prediction of Contractual Reporting Requirements in Construction Using Natural Language Processing and Simulation

2021 ◽  
Vol 11 (13) ◽  
pp. 6188
Author(s):  
Parinaz Jafari ◽  
Malak Al Hattab ◽  
Emad Mohamed ◽  
Simaan AbouRizk
Keyword(s):  
Natural Language Processing ◽  
Natural Language ◽  
Language Processing ◽  
Stochastic Simulations ◽  
Clear Understanding ◽  
Time Cost ◽  
Cost Prediction ◽  
Construction Contracts ◽  
Reporting Requirements ◽  
Reporting Requirement

Due to a lack of suitable methods, extraction of reporting requirements from lengthy construction contracts is often completed manually. Because of this, the time and costs associated with completing reporting requirements are often informally approximated, resulting in underestimations. Without a clear understanding of requirements, contractors are prevented from implementing improvements to reporting workflows prior to project execution. This study developed an automated reporting requirement identification and time–cost prediction framework to overcome this challenge. Reporting requirements are extracted using Natural Language Processing (NLP) and Machine Learning (ML), and stochastic simulations are used to predict overhead costs and durations associated with report preparation. Functionality and validity of the framework were demonstrated using real contracts, and an accuracy of over 95% was observed. This framework provides a tool to rapidly and efficiently retrieve requirements and quantify the time and costs associated with reporting, in turn providing necessary insights to streamline reporting workflows.

scholarly journals Shifting Landscape of Healthcare-Associated Infection and Antimicrobial Resistant Infection Reporting Policy, 2005–2019

2020 ◽  
Vol 41 (S1) ◽  
pp. s389-s389
Author(s):  
Jeremy Goodman ◽  
Samuel Clasp ◽  
Arjun Srinivasan ◽  
Elizabeth Mothershed ◽  
Seth Kroop ◽  
...  
Keyword(s):  
Health Department ◽  
Adverse Outcomes ◽  
Health Departments ◽  
Healthcare Associated Infection ◽  
Candida Auris ◽  
Quality Reporting ◽  
Notifiable Diseases ◽  
Reporting Requirements ◽  
Resistant Infection ◽  
Healthcare Associated

Background: Healthcare-associated infections (HAIs) are a serious threat to patient safety; they account for substantial morbidity, mortality, and healthcare costs. Healthcare practices, such as inappropriate use of antimicrobials, can also amplify the problem of antimicrobial resistance. Data collected to target HAI prevention and antimicrobial stewardship efforts and measure progress are an important resource for assuring transparency and accountability in healthcare, tracking adverse outcomes, investigating healthcare practices that may spread or protect against disease, detecting and responding to the spread of resistant pathogens, preventing infections, and saving lives. Methods: We discuss 3 healthcare-associated infection and antimicrobial Resistant infection (HAI-AR) reporting types: NHSN HAI-AR reporting, reportable diseases, and nationally notifiable diseases. HAI-AR reporting requirements outline facilities and data to report to NHSN and the health department to comply with state laws. Reportable diseases are those that facilities, providers, and laboratories are required to report to the health department. Nationally notifiable diseases are those reported by health departments to the CDC for nationwide surveillance and analysis as determined by Council of State and Territorial Epidemiologists (CSTE) and the CDC. Data presented are based on state and federal policy; NHSN data are based on CDC reporting statistics. Results: Since the 2005 launch of the CDC NHSN and publication of federal advisory committee HAI reporting guidance, most states have established policies stipulating healthcare facilities in their jurisdiction report HAIs and resistant infections to the NHSN to gain access to those data, increasing from 2 states in 2005, to 18 in 2010, and to 36 states, Washington, DC, and Philadelphia in 2019. Reporting policies and NHSN participation expanded greatly following the 2011 inception of CMS HAI quality reporting requirements, with several states aligning state requirements with CMS reporting. States listing carbapenem-resistant Enterobacteriaceae (CRE) as a reportable disease increased from 7 in 2013 to 41 states and the District of Columbia in 2019. Vancomycin-intermediate and vancomycin-resistant Staphylococcus aureus (VISA/VRSA) was added as a nationally notifiable disease in 2004, carbapenemase-producing CRE (CP-CRE) was added in 2018, and Candida auris clinical infections were added in 2019. The CDC and most jurisdictions with HAI reporting mandates issue public reports based on aggregate state data and/or facility-level data. States may also alert healthcare providers and health departments of emerging threats and to assist in notifying patients of potential exposure. Conclusions: Through efforts by health departments, facilities, patient advocates, partners, the CDC, and other federal agencies, HAI-AR reporting has steadily increased. Although reporting laws and data uses vary between jurisdictions, data provided serves as valuable tools to inform prevention.Funding: NoneDisclosures: None

scholarly journals Evaluating performance of health care facilities at meeting HIV-indicator reporting requirements in Kenya: an application of K-means clustering algorithm

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Milka Bochere Gesicho ◽  
Martin Chieng Were ◽  
Ankica Babic
Keyword(s):  
Clustering Algorithm ◽  
Distinct Pattern ◽  
Health Care Facilities ◽  
Health Facilities ◽  
Hiv Care ◽  
Care Providers ◽  
Homogeneous Groups ◽  
Reporting Requirements ◽  
Low Middle Income Countries ◽  
Over Time

Abstract Background The ability to report complete, accurate and timely data by HIV care providers and other entities is a key aspect in monitoring trends in HIV prevention, treatment and care, hence contributing to its eradication. In many low-middle-income-countries (LMICs), aggregate HIV data reporting is done through the District Health Information Software 2 (DHIS2). Nevertheless, despite a long-standing requirement to report HIV-indicator data to DHIS2 in LMICs, few rigorous evaluations exist to evaluate adequacy of health facility reporting at meeting completeness and timeliness requirements over time. The aim of this study is to conduct a comprehensive assessment of the reporting status for HIV-indicators, from the time of DHIS2 implementation, using Kenya as a case study. Methods A retrospective observational study was conducted to assess reporting performance of health facilities providing any of the HIV services in all 47 counties in Kenya between 2011 and 2018. Using data extracted from DHIS2, K-means clustering algorithm was used to identify homogeneous groups of health facilities based on their performance in meeting timeliness and completeness facility reporting requirements for each of the six programmatic areas. Average silhouette coefficient was used in measuring the quality of the selected clusters. Results Based on percentage average facility reporting completeness and timeliness, four homogeneous groups of facilities were identified namely: best performers, average performers, poor performers and outlier performers. Apart from blood safety reports, a distinct pattern was observed in five of the remaining reports, with the proportion of best performing facilities increasing and the proportion of poor performing facilities decreasing over time. However, between 2016 and 2018, the proportion of best performers declined in some of the programmatic areas. Over the study period, no distinct pattern or trend in proportion changes was observed among facilities in the average and outlier groups. Conclusions The identified clusters revealed general improvements in reporting performance in the various reporting areas over time, but with noticeable decrease in some areas between 2016 and 2018. This signifies the need for continuous performance monitoring with possible integration of machine learning and visualization approaches into national HIV reporting systems.

Reporting requirements under health care

2010 ◽  
Vol 22 (2) ◽  
pp. 71-73
Author(s):  
Caroline D. Strobel
Keyword(s):  
Health Care ◽  
Reporting Requirements
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