Evaluation of IFU for a creatinine patient meter

• Research type

  Research Study

• Full title

  An evaluation of comprehensibilty and clarity of Instructions For Use (IFU) for a patient selftesting device used to measure creatinine

• IRAS ID

  206023

• 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, 1 months, 1 days

• Research summary

  A new self-monitoring patient meter The Nova Max Creatinine Monitoring System, has been designed for the quantitative measurement of creatinine levels. This study will evaluate the comprehensibility and clarity of the instruction manual for the new meter.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  16/EE/0204

• Date of REC Opinion

  13 May 2016

• REC opinion

  Further Information Favourable Opinion