Submission for Lancet Protocol Review Title A study ... - NHS Lothian

A separate further study is planned that will assess the impact of using the
CDR on admission rate, outpatient follow-up rate and detection of serious
outcomes. A separate cost benefit analysis study will also be performed.
Ethics Committee approval
This study received full ethical approval from the MREC for Scotland A Ethics
committee (Reference: 06/MRE00/107) and Lothian REC (Reference:
06/S11ADMIN/151) on January 8 th 2007, and a submitted substantial
amendment was approved on 22 nd February 2007. Lothian R&D
management approval was also obtained on 24 th January 2007 (Reference:
2006/R/AE/03).
Informed consent and information sheet
MREC approval has been obtained for the study Patient Information Sheet,
Patient Information Sheet for Relatives, Patient Consent Form, Patient
Consent Form for Relatives and GP Information Sheet.
Dissemination
It is anticipated that the study results will be submitted for to a internationally
renown peer reviewed journal and presented at both national and international
meetings and conferences.
Sponsor
Chief Scientist Office of the Scottish Executive (Reference No: CSO/CAF/01)
Start date (recruitment): March 2007
Finish Date (18 months recruitment): July 2008
Finish Date (1 month follow up): August 2008
Expected Reporting Date: November 2008
Version 14: 14/06/2007 10