How to manage adverse events ?
Sibylle DUPONT
Created on August 7, 2023
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Transcript
Version 1.2 of 03/12/2024 based on v6.12 of MIRIO - ©2024 Deeplink Medical – Confidential – Document covered by the industrial and comercial confidentiality
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How to manage adverse events ?
From the Clinical trial study portal, click on the Tele-Monitoring icon to access specific patients questionnaires tab
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Access the follow-up of adverse events
Capture d'écran MIRIO
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Click on the Reporting of adverse events tab. You can manually add a new AE or open an AE created automatically following the patient's answers (PRO-CTCAE questionnaire), delete an AE, sort the table by date / EI / Grade
Access the follow-up of adverse events
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How to edit AE Informations
SUIVANT
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If necessary, an AE of type “XXXXX - other, specify” can be selected. In this case a free description field is made available:
How to edit AE Informations
SUIVANT
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It is possible to add as many concomitant treatments as possible for the same AE, using the button The start and end dates must be completed for each treatment separately. A treatment can be deleted with
How to edit AE Informations
Click on Report Preview to review and generate the final report of AEs.
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How to edit the final Report
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