Adverse events reporting and harms {22}
adverse reaction
ADVERSE EFFECTS, EVENT, ADVERSE REACTION
The PhD candidate will have thorough training on the operation of the machine, familiarise herself with the troubleshooting scheme, and closely monitor adverse effects during PEMF. In the event of a severe adverse reaction to the PEMF, it will be reported to the trial steering committee immediately. The participant will be removed from the trial and referred to the outpatient clinic at the Prince of Wales Hospital.An independent auditor from the ethics committee will conduct the trial conduct annually. The trial steering group meet weekly to report research progress to the principal investigator. The principal investigator will complete a standardised progress report form for the ethics committee to review conduct annually during the trial period.