Communication, monitoring

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• Communication, monitoring
• and recruitment targets

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Communication

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

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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)

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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)

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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.

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Monitoring

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

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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.

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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

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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.

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Central statistical monitoringData Monitoring
Committee (DMC)

• The DMC is an independent group of experts
• who meet annually, to review accumulating data.
• Met on 16th 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.

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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?

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Revised monthly recruitment by region