Chapter 10. Setting Up, Conducting and Reporting Trials

  1. Allan Hackshaw Deputy Director1,2

Published Online: 29 APR 2009

DOI: 10.1002/9781444311723.ch10

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

How to Cite

Hackshaw, A. (2009) Setting Up, Conducting and Reporting Trials, in A Concise Guide to Clinical Trials, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311723.ch10

Author Information

  1. 1

    Cancer Research, UK

  2. 2

    UCL Cancer Trials Centre, UK

Publication History

  1. Published Online: 29 APR 2009
  2. Published Print: 10 APR 2009

ISBN Information

Print ISBN: 9781405167741

Online ISBN: 9781444311723

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Keywords:

  • setting up and conducting clinical trials - summarises the clinical trial process;
  • number and type of staff required – depends on complexity of trial and sample size;
  • investigational medicinal product (IMP);
  • sponsor: individual, company, institution or organisation which takes responsibility initiation, management and financing of a clinical trial;
  • chief investigator (CI): person responsible for trial design and conduct;
  • investigator: person responsible for conducting the trial at a site

Summary

This chapter contains sections titled:

  • Pre-trial

  • Trial set up

  • Trial conduct

  • End of trial

  • Monitoring adverse events

  • Reporting clinical trials in the literature

  • Summary

  • Glossary of common terms

  • References