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.
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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