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Managing the Systems

Managing the Systems. Managing the Systems. Managing the Systems. How to avoid systems getting corrupted Restrict access Only RTO staff No playing games on-line No unauthorised flash keys or data sticks No downloading unnecessary software from Internet (Can introduce viruses).

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Managing the Systems

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  1. Managing the Systems

  2. Managing the Systems

  3. Managing the Systems • How to avoid systems getting corrupted • Restrict access • Only RTO staff • No playing games on-line • No unauthorised flash keys or data sticks • No downloading unnecessary software from Internet (Can introduce viruses)

  4. Managing the Systems • How to avoid systems getting corrupted • Anti-virus Software • MUST be installed on all computers • Keep up-to-date daily

  5. Managing the Systems • To maintain good IT systems • Talk to us at the ICC • Have access to local IT support

  6. Randomisation Problems • Automated telephone system • Misunderstanding of some questions • Web randomisation • Intermittent connection • No connection at all

  7. RandomisationProblems • Automated telephone system • Our records suggest that this woman has already been recruited into the trial. Please confirm that she has NOT been recruited into the CORONIS trial. Press 1 if this is correct or 0 if not.

  8. Randomisation Problems • Automated telephone system • We have similar data for a woman from your centre who has been recruited in the last 48 hours. • If you are SURE this is a different woman, press 1 to continue. • If you are NOT sure, you must check the woman’s notes and call back later. Press 0 to end this call.

  9. Randomisation Problems • Automated telephone system – 1 weeks statistics • In two weeks the call was prematurely terminated at: • That ‘difficult’ question – 6 occasions • Asked to say woman’s initials – 2 occasions • Incorrect doctor code – 2 occasions • Incorrect age – 2 occasions • The server broke!

  10. Randomisation Problems • Web randomisation • Undersea cables being cut. This affected India and Pakistan • Overloaded lines. This has affected Ghana and Kenya • Intermittent connection. This has affected most centres

  11. Randomisation • In spite of these problems you have recruited: • 2713 Using the web system • 888 By the automated telephone system • 345 By taking the lowest numbered envelope

  12. The Other Problem • Viruses • These have caused the most severe problems • Computers out of action • Hard drive had to be completely re-formatted • New software bought

  13. What now? • Treat computers with tender loving care • Do not change the operating system (Windows XP) or the underlying software (Office XP) • Train new staff in anti-virus procedures • Talk to us first before making any system changes or adding new software

  14. Data Processing • Has a linear progression • Randomisation • Download Trial Entries • Enter After Delivery Data • Enter Postpartum Stay Data • Enter 6 week Data • Upload to Oxford

  15. Data Processing • Data can only be entered in this pattern • Resolve errors and get missing data from participating sites quickly • We still have some queries that have been sitting in the RTO from before April this year and 6 from as long ago as 2007

  16. Data Processing • On-screen error messages when doing data entry • Often ignored • Previous Sections • In labour at randomisation • Parity • Time between randomisation and surgery

  17. Data Processing • Reports • For a reason – do NOT ignore them • Act on them • Ask ICC if there is anything you do not understand or reports are giving wrong information

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