Organon trials with Macro

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Organon trials with Macro

• e-CRF Does the e make a difference?

Author Renate Verbeeten van Hoof Function
Project Data Manager Date 20 February 2008
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Topics

• What happened since the last MUG- Trials-
  Organization
• Lessons learned - Changing roles Data manager
  Monitor- Adapt programming edit checks-
  Training

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Trials - facts and figures

• 3 trials completed
• 7 trials ongoing
• Over 7,000 subjects included
• Up to now more than 7 million datapoints
  collected
• gt 1,000 users (sites, monitors, data management)
• Approx. 320 participating sites in all
  continents
• Online and offline sites

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Organization

• Validation Clinical Gateway OC 4.5 completed
• EDC Core team with members from monitoring, data
  management and project management Infermed -
  gather all issues from the trial teams and seek
  overall solutions- main contact with Infermed
• User manuals and training materials for
  monitoring, sites and data management are in
  place, but require continuous adaptation due to
  growing experience
• In view of acquisition of Organon Biosciences by
  Schering-Plough no new trials will be started
  with Macro

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Lessons learned Changing roles Data manager -
Monitor

• Data transferred continuously from Macro into
  CDMS. Data manager should realize that data in
  CDMS may not be monitored yet
• Data manager and Monitor review data in
  parallel- Data manager is responsible for
  discrepancies in CDMS- Monitor is responsible
  for discrepancies in Macro
• Data manager sends discrepancies directly to site
• Realisation of split responsibilities in query
  resolution

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Lessons learned Adapt programming edit checks

• Timing of discrepancies in line with e-process
• Example AE stop date marked ongoing while
  only definite at End of Trial ? query to fire
  after EOT is entered
• Rephrase text of discrepancies and shorten length
  of query - there is no Monitor to explain
  before investigator responds - discrepancy pops
  up at the relevant data pointExample paper
• Pre-treatment medication PARACETAMOL is
  reported with primary reason for administration
  HEADACHE. Please report HEADACHE and provide
  all details as asked for on the Medical history
  form or AE form.
• e-CRF
• Please report this condition on the Medical
  history form or AE form.

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Lessons learned Training (1)

• Training on the EDC systeme.g. tips and tricks,
  how to make use of the search panel, customized
  reports
• Training on instructions
• e.g. - what to do with empty eForms- not only
  respond to the discrepancy, but also make the
  update in Macro

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Lessons learned Training (2)

• Training on processe.g. Monitors should -
  monitor overrule reasons- monitor responded
  discrepancies from data management - ensure that
  there are no missing items or warnings
  anymore- SDV all eForms
• Realisation that there is a need to frequently
  retrain the system, the instructions and the
  process

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Lessons learned - Conclusions

• Realize that the role between Data manager en
  Monitor concerning data review and query
  resolution has changed
• Realize that training and retraining is essential
  for a new system
• Realize that there should be an increased
  dialogue on responsibilities and on quality of
  the data

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e-CRF technology ...
Works straight from the box
You will get to wherever you want not without
some sort of fuss
Performing trials will never be the same again
Start but without limiting your time and effort
in applying lessons-learned
Youll quickly learn to adapt your paper
procedures
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Conclusion

• e-CRF Does the e make a difference?
• YES, apart from buying and installing hardware
  and software, we should continuously learn along
  the way how to optimise our processes and
  procedures
• sharing experiences is very valuable