During the course of a clinical trial, the occurrence of adverse events must be carefully monitored and recorded. For this process, special forms to report trial-related adverse events should be developed. Serious adverse events must be notified to the data monitoring office and the trial team promptly. It is important that a system for prompt and efficient notification of any unexpected or serious adverse event be set up.
Illustrative example -WHO pre-eclampsia
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Data management Data will be collected prospectively by the researcher responsible at the local collaborating centre and forms will be sent to the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) at WHO headquarters in Geneva monthly following the standard data management procedure of HRP. Side effects will be recorded by the researcher. Although it is very unlikely that serious adverse events will occur, these will be recorded in special forms and will be returned by the local investigators to the Trial Coordination Unit (HRP/WHO in Geneva) by facsimile within 24 hours of the event. These procedures have been used in multiple multicentre trials and proven to be very efficient and compliant with the GCP principles and data management. Data entry will be done centrally in Geneva. Unblinding The need for unblinding should be extremely rare as the trial intervention is not associated with severe side effects and it will not delay or prevent standard management of the patient in the case of a complication such as renal calculi. If the woman develops pre-eclampsia or eclampsia, she will be treated according to routine treatment protocols regardless of the supplementation status. If, however, unblinding is needed for any reason the principal investigator will be informed and, if necessary, the trial coordinator will be contacted to reveal the code. (WHO Multicentre Randomised Trial of Calcium Supplementation for the Prevention of Pre-eclampsia - go to protocol) |
Illustrative example - CRASH trial
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Unexpected adverse events |
Illustrative example - Perinatal care trial
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Adverse Events |
This checklist has been contributed by Dave Sackett, who prepared it for the forthcoming 3rd edition of Clinical Epidemiology; A Basic Science for Answering Questions about Health Care, to be published by Lippincott, Williams & Wilkins in 2005.
This checklist has been contributed by Barbara Farrell who prepared it for the second version of the Trial Management Guide.
This is a sample form for reporting serious adverse events.
This is a sample form for reporting adverse events.