Establishment of CE Marked Equipment in Children
Research type
Research Study
Full title
Establishing clinical and research validity, and normative values for CE marked devices in children.
IRAS ID
189406
Contact name
Steve Cunningham
Contact email
Sponsor organisation
NHS Lothian
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
To enable staff working in research and clinical areas to ask children (through their parents) to participate with tests on CE marked devices to enable children (and staff) to gain sufficient expertise in the technique for satisfactory research and clinical validity. To also enable children to provide non-interventional normative data from associated testing of CE marked devices.
REC name
South East Scotland REC 01
REC reference
15/SS/0175
Date of REC Opinion
13 Oct 2015
REC opinion
Unfavourable Opinion