In a recent monitoring activity our monitors found the study team doing retrospective documentation of source data which ought to have been done a week earlier. does this amount to fraud?

Gilbert

Reply

  • NKisengese Nicodemus Kisengese July 28, 2010

    where are you colllecting the source data from? participants? machine records?

  • gogetii Gilbert Ogetii July 28, 2010

    from participants...

  • wenny Ednah Wenwa July 29, 2010

    Hi Gilbert,I don't see how this would amount to fraud as only the documentation of the original work was delayed. It would only be fraudulent if they backdated the documentation to fit into the required schedule.

  • gogetii Gilbert Ogetii July 29, 2010

    Thanks ednah, in the said case the documentation was backdated because these were meant to be patient observations and by the time the documentation was being made the patient had long been discharged!

  • CMaingi Cmaingi July 29, 2010

    Hi Gilbert,Was these data really collected or it was also fake data?

  • gogetii Gilbert Ogetii July 30, 2010

    Hi Charity, it reported to have been collected but not duly documented... staff believed they could recall the data!

  • Naomi Naomi Waithira July 30, 2010

    In this case,it is likely that the study team member will not give an accurate recording of the patient's observations after one week. While it is hard to prove that what was recorded is the actual observation (or not), the approach I would take is address the reason why recording patient's observations is delayed for up to one week. Is there a trend? It may be a case of under-staffing,negligence etc.

  • jchandra jchandra Aug. 2, 2010

    Greetings from India. I think the case you report is a common one and I contragulate you for raising it it likely happens and people do not comment or report. It seems it happened with the best intentions and this is fine and something that might be helped by training. The point is that a source document is just that 'original source' so cannot be generated retrospectively. Training would help and it can help remind staff what is what and give them confidence. Mistakes happen and that is fine and i was taught that the most important this is always to document. So really they just needed to do like they have done, but acknowledge that they have not produced 'source data' but instead captured what they beleived was the data/situation at the time as a report and then write a filenote (the best tools to help in so many eventualities!). Then they need to ammend their practices to ensure the source data is all ok from that point forward. No one is perfect and mistake are allowed and expected. It is a matter of what we learn and how they are documented. I hope that is helpful, it is just my view and what I would do.

  • gogetii Gilbert Ogetii Aug. 2, 2010

    Thanks Naomi for your very helpful comments

  • gogetii Gilbert Ogetii Aug. 2, 2010

    Hi Chandra thanks for you comments which directly address the issue at hand. I find the suggestions on corrective actions very helpful.

  • Roma Roma Chilengi Aug. 4, 2010

    Hi all,

    Allow me to simply agree with Chandra, but to also emphasize that back-dating is not acceptable. It is OK to call back the patients and document as suggested, but the date has to be on the material day.

    Roma

  • jessegitaka Jesse Gitaka Aug. 4, 2010

    Hi Gilbert, retrospective documentation of source data is certainly likely to lead to false data which mirrors the study findings more so if touching on the end points determinants. do you suppose that monitoring pressure may have precipitated this? quite sad, monitoring ought to be more of supportive rather than adversarial.

  • Nanfuka Rehma Nanfuka Kisakye Aug. 8, 2010

    Hi all,

    This is a good question. Thanks Gilbert for posting it.
    My opinion, though not very differnt from Roma's and Chandra's above, is that retrospective documentation is not necessarily fraudulent however, it simply shouldn't be happening! Just to get it clearly, at what point were CRFs completed? Within the week before source data was documented or after? If CRFs are being completed before source documentation, then the meaning of source (original / first record of) data ceases to exist. If the CRFs are being completed after, and hence by copying data from the source, the quality of that data (on the CRFs) would be questionable..(I think)..and this is not good at all for the integrity of the whole trial.

    If I was the monitor for this site, I'd definitely retrain the team on source documentation (though chances are high that this team is well informed about it) or try to find out why this practice is happening (maybe understaffing, or negligency like Naomi commented) and try to solve it together with the team.

  • gogetii Gilbert Ogetii Aug. 13, 2010

    Thank you all for the good discussion on this subject and am sure we've all learnt form everyone's contribution

    Gilbert

  • rravinetto Raffaella Ravinetto Aug. 18, 2010

    Hi Gilbert, sorry, I am a bit late!

    I would also agree that retrospective documentation is not necessarily fraudulent: it becomes "fraudolent" if there is deliberate backdating. However, it can be seen as "misconduct" or "malpractice", and it can negatively affect the reliability of the study data, because of the difficulty/ impossibility to recall accurate information later on.
    In addition to retraining the team, the monitor could also assess the tools where source data are collected. If it has to be collected, for instance, on a hospital record form which is not always quickly available, the monitor could help the team to design a study-specific source document template, which is more easily available all the time.

    Good luck! Raffaella

  • Nanfuka Rehma Nanfuka Kisakye Aug. 25, 2010

    Thanks Raffaella. That is a very good point (about the source document).

  • fbaiden fbaiden Sept. 7, 2010

    Thanks for this interesting discussion. The topic here borders on a common misconception of what a source document is and should be. The word "original" in the ICH definition of SD is key! If the team has found it okay thus far to enter data directly into the CRF and are only now back-copying onto another form in order to have something to show the monitor as "source document", then in all likelihood, this study does not need the so-called form that is used as "source document" and they will be better off abandoning it,even if it means amending their protocol or SOPs to state that "data will be collected and entered directly into the CRF". They will save themselves the attendant issues of transcription errors, time and resources that could be committed to improve others areas of the trial. The decision NOT to use the CRF as source document should be taken with caution and with all the considerations made of the available time and resources. It is a common source of unnecessary frustration to many in clinical trials in resource-limited settings. What they are doing could be called fraud, but only to the extent they will be calling something by a name that it is not!! The essential about a source document is not the form or sheet on which it is written, but about where the information referred to is coming from -SOURCE!!!

  • fbaiden fbaiden Sept. 7, 2010

    Thanks Raffaella!
    The approach you propose is a route often taken by many monitors - namely, cause the creation of more study forms - quasi-CRFs, worksheets etc. If the information is being collected on routine hospital forms, then the challenge of its availability for source document verification should be addressed, rather than creation of new forms. Lets remember the team that is already struggling will now have to complete the routine hospital formS, the new-created formS and then the CRF!!

  • VivatThomas_Njie Vivat Thomas-Njie Oct. 5, 2010

    Dear Gilbert,
    Thank you for raising such a pertinent issue, we recently had such an incidence at a site, and what happened was the notes were written up with the current date (not back-dated) and a file note generated to explain what had happened. I agree that this is not best practice and re-training of staff on what Source data means should be done and not just having something done for the Monitor's visit. I like what Chandra said that the site must "acknowledge that they have not produced 'source data' but instead captured what they beleived was the data/situation at the time as a report and then write a filenote (the best tools to help in so many eventualities!).
    Thank you Chandra for that
    Regards
    Vivat

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