Evaluation of IFUs for creatinine and uric acid patient meters

• Research type

  Research Study

• Full title

  An evaluation of the comprehensibility and clarity of instructions for use (IFU) for patient self-testing devices used to measure blood creatinine and uric acid levels.

• IRAS ID

  194488

• Contact name

  Maurice O'Kane

• Contact email

  Maurice.OKane@westerntrust.hscni.net

• Sponsor organisation

  NOVA Biomedical UK

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  0 years, 2 months, 9 days

• Research summary

  Two new self-monitoring patient meters have been designed; one to measure blood creatinine and one to measure uric acid levels. This study will evaluate the comprehensibility and clarity of the IFUs for the new meters.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  15/NW/0955

• Date of REC Opinion

  8 Dec 2015

• REC opinion

  Further Information Favourable Opinion