The nurse of a patient in the CHiP trial forgot to do a blood glucose measurement and the blood glucose dropped to < 2.5 mmol/l thus requiring a bolus of glucose. Do we need to report the incident?
Yes. This would be classified as a Serious Adverse Reaction and needs to be reported within 24 hours. A Trust Incident Reporting Form should also be completed according to your local practice. A blood sugar measurement was not taken within the timescale suggested in the CHiP insulin flowchart as he/she was too busy. The blood sugar was within a safe range when a blood sugar was eventually taken. Do we need to report this as a trial adverse incident? No, you do not need to report this as a serious adverse event but you may need to follow your trust incident reporting procedures if it is appropriate.
Related Questions
- The nurse of a patient in the CHiP trial forgot to do a blood glucose measurement and the blood glucose dropped to < 2.5 mmol/l thus requiring a bolus of glucose. Do we need to report the incident?
- A child in the CHiP trial required a bolus of glucose for a blood sugar <2.5 mmol/l. Do we need to let the Chief investigator/Lead study nurse know?
- My patient has just been entered into the CHiP Trial and I have taken a waist circumference measurement. Where do I document it?
