Excess Property Operations of Agency for International Development - 1968

Excess Property Operations of Agency for International Development - 1968 PDF Author: United States. Congress. House. Government Operations
Publisher:
ISBN:
Category :
Languages : en
Pages : 122

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Excess Property Operations of Agency for International Development - 1968

Excess Property Operations of Agency for International Development - 1968 PDF Author: United States. Congress. House. Government Operations
Publisher:
ISBN:
Category :
Languages : en
Pages : 122

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Book Description


ePro

ePro PDF Author: Brian Tiplady
Publisher: CRC Press
ISBN: 1317141911
Category : Business & Economics
Languages : en
Pages : 294

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Book Description
Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.

Mithriaca III

Mithriaca III PDF Author: Maarten Jozef Vermaseren
Publisher: BRILL
ISBN: 9789004065000
Category : Religion
Languages : en
Pages : 164

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Hospital Prospective Payment System

Hospital Prospective Payment System PDF Author: United States. Congress. Senate. Committee on Finance. Subcommittee on Health
Publisher:
ISBN:
Category : Hospitalization insurance
Languages : en
Pages : 508

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Clinical Trial Project Management

Clinical Trial Project Management PDF Author: Ashok Kumar Peepliwal
Publisher: Elsevier
ISBN: 0443136289
Category : Business & Economics
Languages : en
Pages : 352

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Book Description
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

Outcomes in Clinical Trials

Outcomes in Clinical Trials PDF Author: Martin Kolb
Publisher: European Respiratory Society
ISBN: 1849840458
Category : Medical
Languages : en
Pages : 208

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Book Description
The traditional end-points for clinical studies of lung diseases were based on functional parameters. Their value as surrogate markers for disease activity and progression has been increasingly questioned by scientists, carers, regulatory agencies and funding bodies. Novel tools and methods with regard to biomarkers and patient-reported outcomes have made these parameters emerge from their status as interesting secondary end-points and become potential primary outcomes for clinical trials. Nevertheless, their relevance and validity still needs to be proven. This issue of the European Respiratory Monograph describes the current status regarding end-points in all relevant areas of pulmonary medicine.

Digital Personalized Health and Medicine

Digital Personalized Health and Medicine PDF Author: L.B. Pape-Haugaard
Publisher: IOS Press
ISBN: 1643680838
Category : Medical
Languages : en
Pages : 1498

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Book Description
Digital health and medical informatics have grown in importance in recent years, and have now become central to the provision of effective healthcare around the world. This book presents the proceedings of the 30th Medical Informatics Europe conference (MIE). This edition of the conference, hosted by the European Federation for Medical Informatics (EFMI) since the 1970s, was due to be held in Geneva, Switzerland in April 2020, but as a result of measures to prevent the spread of the Covid19 pandemic, the conference itself had to be cancelled. Nevertheless, because this collection of papers offers a wealth of knowledge and experience across the full spectrum of digital health and medicine, it was decided to publish the submissions accepted in the review process and confirmed by the Scientific Program Committee for publication, and these are published here as planned. The 232 papers are themed under 6 section headings: biomedical data, tools and methods; supporting care delivery; health and prevention; precision medicine and public health; human factors and citizen centered digital health; and ethics, legal and societal aspects. A 7th section deals with the Swiss personalized health network, and section 8 includes the 125 posters accepted for the conference. Offering an overview of current trends and developments in digital health and medical informatics, the book provides a valuable information resource for researchers and health practitioners alike.

Electronic Patient-Reported Outcome Measures

Electronic Patient-Reported Outcome Measures PDF Author: Bill Byrom
Publisher:
ISBN: 9781720281108
Category :
Languages : en
Pages : 96

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Book Description
The book concisely covers the entire landscape of ePROs and helps to dispel some of the myths and doubts on the topic. After making the case for ePRO assessment, the authors take the readers on a tour of issues related to design, validation, and implementation of ePRO solutions. The authors have provided recommendations ("Should skipping of items allowed?"), mitigation strategies ("How can we minimize issues that may arise during user acceptance testing?") and common pitfalls, such as issues that may arise when administering these assessments to patients from a variety of cultures. The bibliography of industry standards and best practices and the key references related to ePRO assessment make this book a valuable resource for anyone who wants to take a deep dive into the topic. Although the title of the book refers to patient-reported outcomes, the volume is a must-have for those who want to collect accurate and high-quality data relating to clinical outcomes in clinical trials. The authors are donating all royalties from the sale of this book. All royalties from book sales prior to October 2019 will be shared between the following registered charities. 50% of the royalties from the sale of this book will be donated to StoneBridge City Farm, Nottingham, UK. Stonebridge City Farm is a city farm in St. Ann's, Nottingham, looking after a range of animals, large and small and growing seasonal vegetables and herbs. They are a registered charity supporting people from Nottingham with learning disabilities. http: //www.stonebridgecityfarm.com/. Registered Charity Number: 1125245. 50% of the royalties will go to Make-A-Wish Ireland. Make-A-Wish Ireland has one simple aim - to grant the wishes of children with life-threatening medical conditions, to bring hope, strength and happiness. Since 1992, Make-A-Wish has granted wishes for more than 2,300 brave children across Ireland. A wish granted is true magic for the child, providing respite from their normal routines of hospitals, doctors and treatment. Make-A-Wish does not receive any government funding, and relies overwhelmingly on the kindness of the Irish public to continue granting wishes. https: //www.makeawish.ie/ Charity Registration Number: CRA20052256 / CHY15267

Staff Memorandum on United States Investment of Military Assistance Funds in Military Installations Located in France

Staff Memorandum on United States Investment of Military Assistance Funds in Military Installations Located in France PDF Author: United States. Congress. House. Committee on Foreign Affairs
Publisher:
ISBN:
Category : Military assistance, American
Languages : en
Pages : 1190

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Analysis of Messy Data, Volume III

Analysis of Messy Data, Volume III PDF Author: George A. Milliken
Publisher: CRC Press
ISBN: 1420036181
Category : Mathematics
Languages : en
Pages : 625

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Book Description
Analysis of covariance is a very useful but often misunderstood methodology for analyzing data where important characteristics of the experimental units are measured but not included as factors in the design. Analysis of Messy Data, Volume 3: Analysis of Covariance takes the unique approach of treating the analysis of covariance problem by looking