1. Communication, monitoring and recruitment targets

2. Communication Communication is vital if we are to maintain a successful collaboration. Communication is easy in 2008. Communication must be at every level.

3. Communication From us to you: –Daily email –Fortnightly data updates –Quarterly newsletters –Presentations at local and national meetings by Regional Co-ordinators or the ICC team –The trial website (www.npeu.ox.ac.uk/coronis)

4. Communication From you to us: –Weekly data email (a minimum) –Respond to our emails –By telephone in an emergency –The trial website (www.npeu.ox.ac.uk/coronis)

5. Communication From you to your colleagues This is your major role and only you can do it. Give them regular updates about the progress of the trial; email, phone or visit. On-going training and trial awareness. Ask for contributions to the website news forum.

6. Monitoring 1Regional Co-ordinator’s monitoring role; recruitment, data collection and staff competencies. 2International Co-ordinating Centre (ICC) monitoring of overall recruitment patterns and trends, data accuracy and compliance. ICC will also monitor competencies of RTO teams. 3Site visit monitoring by ICC staff. -For ‘cause’ -Random sampling 4Central statistical monitoring. -Data Monitoring Committee (DMC)

7. Regional Co-ordinators’ monitoring Recruitment, data collection and staff competencies: Regional Co-ordinators are responsible for monitoring the day-to-day activity of the trial in their region. Provide guidance for trial staff. Facilitate on-going training and trial awareness in recruiting hospitals.

8. ICC monitoring Data received in the ICC database at NPEU will be monitored using both computer programmes and manual checking to detect patterns of recruitment, baseline data and data collection trends, accuracy of RTO staff, e.g. –Randomisation procedure failing –Only elective CS recruited –Always recruited on the same day of the week –Only recruited during the daytime –Same errors or omissions repeatedly occurring –Late data entry at Regional Trial Office (RTO) –RTO staff competencies

9. Site visit monitoring Site monitoring will begin in September 2008. During the site visits a random sample of data will be reviewed against the hospital records. All SAEs will be reviewed. Additional site visits will be carried out for data monitoring if the ICC considers there is ‘cause’ to review the data locally.

10. Central statistical monitoring Data Monitoring Committee (DMC) The DMC is an independent group of experts who meet annually, to review accumulating data. Met on 16 th July 2008 for the first time. Data for ~3000 was reviewed. Interim data report provided by the ICC. DMC will make recommendations to the Trial Steering Committee.

11. Recruitment targets 15,000 women will be recruited over 3 years starting 01/09/07. 3936 have been recruited (01/09/07 – 28/7/08). Average of 364 per month. May, June and July exceeded monthly target. What does that mean for your region?

12. Revised monthly recruitment by region