Responsible research : a guide for coordinators

著者

    • Fedor, Carol A.
    • Cola, Philip A.
    • Pierre, Christine

書誌事項

Responsible research : a guide for coordinators

senior editor, Carol A. Fedor ; editors, Philip A. Cola, Christine Pierre

Remedica, c2005

  • : [pbk.]

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注記

Description based on 2009 printing

Includes bibliographical references and index

内容説明・目次

内容説明

Coordinators are an integral element of the clinical research team, and are essential to the efficient running of clinical trials. Yet, the input of coordinators is often unacknowledged and learning and training opportunities can be scarce. "Responsible Research: A Guide for Coordinators" provides a comprehensive resource for coordinators (both experienced and new), monitors, and other study site professionals. The book gives practical information on the many activities and responsibilities that are undertaken by the modern coordinator. The international authorship ensures that the content is relevant to the global body of research coordinators.

目次

The Evolving Role of the Clinical Research Coordinator * Guiding Principles and Regulations * Ethics and Human Subjects Protection * Responsible Conduct of Research * The Informed Consent Process * Pediatric Informed Consent and Assent * Study Implementation and Start-up * Recruitment and Retention of Research Subjects * Documentation * Assuring Quality in Clinical Trials * Communication * Learning: A Continuous Journey * Future trends

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