SAFETY REPORTING INSTRUCTIONS
Please report any potential side-effects of study medication to the ARCHIE study co-ordinating centre at the University of Oxford. Please note that you do NOT need to report the following potential side-effects unless they result in a serious adverse event: diarrhoea, nausea, vomiting, thrush.
If you are based at one of the recruiting sites taking part in our study, please complete the following for each potential side-effect:
- Record the event on the participant’s Adverse Event Report Log (paper copy provided in study pack).
- Send a copy of the log to the trial office, per instructions on the form, after additional information is added. This must be done within 5 working days of becoming aware of the event, unless the adverse event is serious (see below).
If the adverse event is serious, please complete an Adverse Event Report Form and a Serious Adverse Event Report Form and return these to the University of Oxford within 24 hours of becoming aware of the event. You can download our Serious Adverse Event Report Form from our ‘Useful Documents’ link or make a photocopy of the form provided in your Investigator Site File.
Non recruiting sites
If you are not based at one of our recruiting sites, please contact the Local Investigator shown on the child’s ARCHIE study contact card or contact the ARCHIE Trial Manager by telephone on 01865 617842 with the following details:
- Your name
- Your place of work
- A contact telephone or bleep number
- The child’s ARCHIE ID and Medication ID numbers if known