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How eClinical Can Help You

In its 2006 publication 'A Guide To Efficient Trial Management' the UK Trial Managers' Network (UKTMN) underlines the importance of data collection and storage with the phrase 'no data - no trial - it is that important'.

eClinical is specifically designed to allow you to meet your clinical requirements.  Whilst simplifying and automating the data capture processes through scanning, faxed and electronic capture, eClinical also meets many of the specific requirements outlined in this document:

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Make data collection forms and CRFs as attractive and as easy as possible to complete

  • Use trial logos and colours to promote your trial identity
  • Use simple yes/no questions and tick boxes where possible
  • Minimise free text fields and photocopying (use NCR paper)
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Develop and validate computer programmes to support

  • Logic checks (sensible dates e.g. not dead before enrolled)
  • Range checks
  • Consistency checks
  • Coding of free text data
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Data entry

  • Develop a housekeeping system to keep track of data in the office, including date stamping all documents on receipt
  • Immediately enter all data on to the trial database
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Checking data accuracy - Double data entry

  • Data is entered twice by two different people
  • Comparison of the two data entry sets is made to detect inconsistencies and identify queries
  • These may be resolved in house but more often need to be sent back to the investigator for resolution
  • This is a gold standard. It may be sufficient to agree a sample (say 20% or, if simple, key variables) of the data to be double entered. The percentage can be lowered if the data is accurate and raised if the error rate is unacceptable
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Missing and inconsistent data

  • Develop a system of computer-generated reports to monitor missing or inconsistent data and act upon them
  • Many queries will need to be resolved by the investigator and these queries should be sent out as soon as possible with a clear request
  • All query resolutions should go through the same checking process as the original data
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Storage

  • Essential records should be maintained in a legible condition
  • Prompt retrieval should be possible
  • The facilities should be secure, with appropriate environmental controls and adequate protection from fire, flood and unauthorised access

 

NO DATA - NO TRIAL - IT IS THAT IMPORTANT