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  • Book
    Cemal Cingi, Nuray Bayar Muluk.
    Summary: This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard - Good Clinical Practice - provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

    Contents:
    1 Clinical Trials: Historical Aspects and Importance and New Drug Developments
    2 The Definition of GCP
    3 The Principles of GCP
    4 The Drug Development Process and Evolution of Regulations
    5 Planning Clinical Research
    6 Preparation of Ethics Committee (IRB) Proposal
    7 Preparation of Informed Consent
    8 Preparation of Findings Tables
    9 Setting the Ideal Statistical Methods
    10 The Duties of a Clinical Research Coordinator
    11 The Duties of Clinical Researchers
    12 The Phases of Clinical Studies
    13 Safety in Clinical Trials
    14 Setting the Size
    15 Setting the Ideal Method
    16 Ethics of Clinical Research
    17 Recruitment and Enrolment
    18 Why we need Clinical Consent and Other Documentation
    19 Monitoring the Trial
    20 Inspection
    21 Ethics
    Institutional Review Board/Independent Ethics Committee(IRB/IEC)
    22 Responsibilities of the Investigator
    23 Responsibilities of the Sponsor
    24.Clinical Trial Protocols.
    Digital Access Springer 2017