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)

Managing the Systems

• How to avoid systems getting corrupted

– Anti-virus Software• MUST be installed on all computers• Keep up-to-date daily

Managing the Systems

• To maintain good IT systems

– Talk to us at the ICC

– Have access to local IT support

Managing the Systems

• Automated telephone system– Misunderstanding of some questions

• Web randomisation– Intermittent connection – No connection at all

Randomisation Problems

• 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

• 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

• 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

• 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

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

• 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

• 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?

• Has a linear progressionRandomisationDownload Trial EntriesEnter After Delivery DataEnter Postpartum Stay DataEnter 6 week DataUpload to Oxford

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

Data Processing

• On-screen error messages when doing data entry– Often ignored

• Previous Sections• In labour at randomisation• Parity• Time between randomisation and surgery

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

Data Processing