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Sunday, December 9, 2012

The need for a Electronic Lab Notebook

Some of the problems in medical research could have been avoided had we had a proper electronic trail for any inquiry into possible misconduct.

From the top of my head, there are a few things a electronic paper trail should include (possibly more):

  • Material received, put to storage, removed from storage, transferred, shipped, etc.
  • Experiments performed, for what project/study, with what materials, in what lab, with which equipment, by whom and with what results (e.g. Western Blots, EM images, Antibody titers, Gene Sequences and so on)
  • Results received from third parties
  • Patient/Control samples should be coded ("blinded") by default
  • The person who does patient/control sample coding
  • The time of code-breaking for each sample
  • Any corrections to the record (with before/after record)
Of course everything must be recorded with a time-stamp. And all materials (reagents, patient samples, and so on) must have a machine readable label.

The entire electronic paper trail should be kept at the lab and updates be send regularly (Weekly? Or better daily?) to a central storage (e.g. NIH).

Access to the study-relevant electronic paper trail at the central storage (including records from third parties) should be made available at the time of submission for peer-review to the editors/reviewers.

Parts (at least) of the electronic paper trail relevant to the published paper should be made available as supporting online material.

In case of a formal inquiry the entire electronic record of the lab (and third parties) for the time under inquest should be available to the inquiry board.

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