Eliciting adverse effects data from participants in clinical trials

  • Protocol
  • Methodology

Authors

  • Elizabeth N Allen,

    Corresponding author
    1. University of Cape Town, Division of Clinical Pharmacology, Dept of Medicine, Cape Town, Western Cape, South Africa
    • Elizabeth N Allen, Division of Clinical Pharmacology, Dept of Medicine, University of Cape Town, K45, Old Main Building, Groote Schuur Hospital, Observatory, Cape Town, Western Cape, 7925, South Africa. elizabeth.allen@uct.ac.za.

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  • Clare IR Chandler,

    1. London School of Hygiene and Tropical Medicine, Dept of Global Health & Development, London, UK
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  • Nyaradzo Mandimika,

    1. University of Cape Town, Division of Clinical Pharmacology, Dept of Medicine, Cape Town, Western Cape, South Africa
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  • Karen Barnes

    1. University of Cape Town, Division of Clinical Pharmacology, Cape Town, South Africa
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Abstract

This is the protocol for a review and there is no abstract. The objectives are as follows:

To systematically review available literature on research that compares the methods used within, or specific for, clinical drug trials/studies to elicit information from the participants about the AEs that were defined in the protocol or in the preparation for the trial.