1. Managing the Systems

3. 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) Managing the Systems

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

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

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

7. 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. Randomisation Problems

8. 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. Randomisation Problems

9. 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! Randomisation Problems

10. 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 Randomisation Problems

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

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

13. 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 What now?

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

15. 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 Data Processing

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

17. 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 Data Processing