INDICATOR

COMPLIANCE (%)

ACTION POINTS

TARGET DATE FOR FULL COMPLIANCE

1. Do you have a system to ensure that you, or an appropriate member of your staff is notified of, and has approved, all research in your organisation?

100%

Maintain performance monitoring of research registration process to ensure continued compliance.

2. Do you have clear documented agreements with your research partners about the allocation of responsibilities for all research in your organisation?

b. Do you have clear documented agreements with Universities about responsibilities?

50%

100%

i)                    Application to the DoH, to become a recognised sponsor of research and accept responsibility for maintenance of the high quality standards identified in Research Governance Framework for Health and Social Care

ii)                   Agree with all research partners, sponsorship responsibilities and performance monitoring prior to commencement of the research.

i)                    Institute of Ophthalmology contributes and agrees research governance policy reviews and amendments before ratification by the Trust Board

June 30^th 2002

Ongoing

Ongoing

3. Do you have a system in place to ensure that all staff are aware of the Research Governance Framework?

100%

i)                    contracts

ii)                   induction

iii)                 information pack

iv)                 newsletter

v)                  research management infrastructure including research co-ordinator for all activity areas

Ongoing

4. Are links made with clinical governance in your organisation?

b. If you have arrangements to do this, please describe briefly

i)                    Appoint dedicated research co-ordinators for every research activity area with responsibility for co-ordination, data management and performance monitoring

ii)                   Undertake research governance training programme for all research co-ordinators

iii)                 Develop systematic performance monitoring against all standrds identified within the research governance policy.  Set up systems to support full monitoring as opposed to the current random percentage monitoring

March 2003

March 2003

March 2003 partial monitoring

March 2004 - total

i)                    agree principles for the definition of adverse events for individual research projects

ii)                   ensure all potential reportable adverse events are identified within the research proposal form

iii)                 set up data capture system to record adverse events at every point of contact

July 2003

March 2003

September 2003

i)                    Develop performance monitoring system as at 5iii

ii)                   Tighten data entry systems to double entry where appropriate

iii)                 Develop and expand standards for data management including routine and random auditing of data analysis by independent investigators

iv)                 Link data analysis of research findings to clinical audit findings where appropriate

March 2003

March 2003

March 2004

March 2003