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Organon trials with Macro

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1,000 users (sites, monitors, data management) ... Please report this condition on the Medical history form or AE form. 7 ... Training on the EDC system ... – PowerPoint PPT presentation

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Title: Organon trials with Macro


1
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
2
Topics
  • What happened since the last MUG- Trials-
    Organization
  • Lessons learned - Changing roles Data manager
    Monitor- Adapt programming edit checks-
    Training

3
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

4
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

5
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

6
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.

7
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

8
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

9
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

10
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
11
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
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