groups » Trial Management » Elicitation and Recording of Participant-reported Safety Data in Malaria Clinical Drug Trials/Studies -


Research has shown that the results of clinical drug trials and pooled individual participant harms data are influenced by the methods used to collect such data. However, there is no consensus regarding the detail of how participants should be questioned about their health and treatments, or how staff should assess and/or record the data elicited.

The University of Cape Town in conjunction with the ACT Consortium (see http://www.actconsortium.org/pages/project-16-safety.html) is currently conducting a survey of the various methods used by antimalarial clinical researchers to elicit, record and assess participant-reported safety data in their studies (including adverse events, concomitant medications, medical histories and adherence data). This is in preparation for the implementation of a Delphi process whereby researchers with experience in this field will be invited to work towards consensus about the appropriate design of relevant and feasible malaria clinical drug trial safety data methods.

Please click on or type www.surveygizmo.co.uk/s3/925111/ACT-survey to take the survey.

Do not hesitate to contact myself or my colleague, Nyaradzo Mandimika (nyaradzo.mandimika@uct.ac.za), for further details/clarifications.
Thank you and best wishes
Liz Allen

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data recording malaria safety data

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