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Document Drafting Handbook

Document Drafting Handbook PDF Author: Gladys Q. Ramey
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 112

Book Description


Document Drafting Handbook

Document Drafting Handbook PDF Author: Gladys Q. Ramey
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 112

Book Description


Draft Guidance Document for Industry

Draft Guidance Document for Industry PDF Author:
Publisher:
ISBN: 9780662442240
Category : Drugs
Languages : en
Pages :

Book Description


The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163

Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Guideline for the Manufacture of in Vitro Diagnostic Products

Guideline for the Manufacture of in Vitro Diagnostic Products PDF Author:
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48

Book Description


The Belmont Report

The Belmont Report PDF Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614

Book Description


Complementary and Alternative Medicine in the United States

Complementary and Alternative Medicine in the United States PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133424
Category : Medical
Languages : en
Pages : 360

Book Description
Integration of complementary and alternative medicine therapies (CAM) with conventional medicine is occurring in hospitals and physicians offices, health maintenance organizations (HMOs) are covering CAM therapies, insurance coverage for CAM is increasing, and integrative medicine centers and clinics are being established, many with close ties to medical schools and teaching hospitals. In determining what care to provide, the goal should be comprehensive care that uses the best scientific evidence available regarding benefits and harm, encourages a focus on healing, recognizes the importance of compassion and caring, emphasizes the centrality of relationship-based care, encourages patients to share in decision making about therapeutic options, and promotes choices in care that can include complementary therapies where appropriate. Numerous approaches to delivering integrative medicine have evolved. Complementary and Alternative Medicine in the United States identifies an urgent need for health systems research that focuses on identifying the elements of these models, the outcomes of care delivered in these models, and whether these models are cost-effective when compared to conventional practice settings. It outlines areas of research in convention and CAM therapies, ways of integrating these therapies, development of curriculum that provides further education to health professionals, and an amendment of the Dietary Supplement Health and Education Act to improve quality, accurate labeling, research into use of supplements, incentives for privately funded research into their efficacy, and consumer protection against all potential hazards.

The Action Plan Order

The Action Plan Order PDF Author: Great Britain. Home Office
Publisher:
ISBN:
Category : Law
Languages : en
Pages :

Book Description


Draft Guidance Document

Draft Guidance Document PDF Author:
Publisher:
ISBN: 9780660675916
Category : Medical instruments and apparatus
Languages : en
Pages : 0

Book Description


Guide for Submission of Information on Industrial X-ray Equipment Required Pursuant to 21 CFR 1002.10

Guide for Submission of Information on Industrial X-ray Equipment Required Pursuant to 21 CFR 1002.10 PDF Author:
Publisher:
ISBN:
Category : Radiation
Languages : en
Pages : 16

Book Description


Regulation of Biological Products

Regulation of Biological Products PDF Author: National Institutes of Health (U.S.). Division of Biologics Standard
Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 68

Book Description