A Comprehensive and Practical Guide to Clinical Trials

Forfatter: info mangler
Bog
  • Format
  • Bog, paperback
  • Engelsk

Beskrivelse

A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end.

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Detaljer
Størrelse og vægt
  • Vægt340 g
  • coffee cup img
    10 cm
    book img
    15,1 cm
    22,9 cm

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    Backup Screening Training Budget Clinical trials Legislation Research methods Risk assessment Quality assurance Safety Accountability Export Root cause analysis Archive Feasibility Clinical research Inspections Quality Management System Audits Protocol design Database Good Clinical Practice (GCP) Query Archiving Efficacy Research question Serum samples Key stakeholders Achieving recruitment targets clinical trial monitoring Clinical trial application (CTA) Corrective And Preventive Action Clinical Trial Agreement Blood sample collection CRF Clinical trial monitor responsibilities Emergency trolley checklist End of treatment visit Centrifugation process Delegation log Clinical Site Agreement Clinical Trial Phases Close-out visit Fundamental qualities of Source Data Informed Consent Process International Conference of Harmonization (ICH) IMP dosing institutional review board (IRB) Investigational Medicinal Product (IMP) Investigator Meeting Investigator Brochure Noncompliance report GCP training Planning of clinical trial Preclinical trial checklist Preparing for monitor visit Preparation for clinical trial audits and inspections Principles of ICH-GCP regarding source documents Informed consent guidelines Retention of trial participants Principles of blood collection Quality Risk Management Schedule of events in clinical protocol Site assessment checklist Site Initiation Meeting Site selections Site set-up Recruitment challenges Recruitment options Source Document design Safety follow-up visit Sequential steps IATA training Standard contract terms Status report Useful tips for participant retention Medicine Regulatory Authority (MRA) Treatment period Staff schedule Start-Up Meeting Qualification visit Recruitment of trial participants Plasma Samples Nonadherence to protocol or laboratory manual Protocol content Protocol training Quality Checks Storage and shipment Urine sample collection Quality management activities quality management tools Source Documents attributes Signs of potential nonadherence Site assessments Source Data Tolerability

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