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Thread: Hospital Electronic Notes - External Monitors

  1. #1
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    Hospital Electronic Notes - External Monitors

    We as a trust are in a transitional process whereby all hospital records are going electronic, i am trying to gain more advice on what access external study monitors should have when monitoring clinical trials. It is proposed that they have a generic password to log onto the system, once they have completed visit an audit report as to what notes they have viewed is produced. However my concern is that they have access to all notes and although audit report after states notes viewed is this sufficient? how does it effect all other patient notes whereby the patients are not in clinical trials but potentially there data coudl be exposed to external Sponsors?

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    The MHRA GCP Guide (2012) appears to say that monitors, auditors and inspectors should not have free access to EHR of all patients. No advice is given about after-the-fact audit trail information, but I would support what you say, that this does not preclude the possibility of pre-emptive violation of patients rights. MHRA GCP Guide (2012) has some advice (11.5.2):- "Electronic Health Records (EHR) are commonly used in GP practices as well as some hospitals. ... should therefore consider implementing systems that allow for read only access for research purposes by monitors, auditors and inspectors, with access restricted to trial subject data. ... when EHR are used as source data, it is possible that monitors may not have direct access to the system for reasons of confidentiality. ... monitors and inspectors may only have direct access with the supervision of site personnel. . this may be time consuming. An option may be for the site to print out ... It is recommended that site personnel sign and date to verify... certified copy of the EHR and that they represent the complete, chronological set of notes. ..there should be a process for retaining the previous printouts, as these will serve as an audit trial (by comparing older versions against the latest printout).”

  3. #3
    I have a few questions on this topic. The first being, are we any further forward in the access to the systems to review Clinical Trial data from source records? I completely agree and empathise with the restrictions that are needed to preserve non trial patient confidentiality but surely someone could have thought to design a system which would allow access to a discrete set of records electronically, either by a reporting function or otherwise? I know for a fact that many staff enter these clinical systems and are not sure of all the nooks and cranny's within the system so printing out does not always give all information and can sometimes be very selective.

    The second point is - these printouts - where are they being stored at the end of the study? I was recently told (not UK) that the printouts used by the monitor for SDV could not be kept at the end of the study. I accepted this because of the fact that the system in use was fully validated and informatoin entered could not be modified or changed without the audit trail function. It was also possible to see who had entered the data and when plus who had printed the data and when. So are these printouts always being kept and in the event of an audit or inspection what checks are being done to ensure that the data has not been modified or is identical to the printouts? I note the point about chronological notes and retaining of previous printouts but how many trusts or GPs or the like have a proper SOP or equivalent in place to do this at their site?

    The third point is those sites which will not print and sign and date in a timely manner or will only do it once, or will not go back and confirm that nothing has been changed. How are these being dealt with?

    My last point is that I believe that CRAs/Monitors are not being trained sufficiently in how to assess e systems at site and due to their lack of knowledge they are unable to extrapolate what they see and find back to the regulations and also, when faced with issues at site they are either oblivious to them or just do not know how to handle the issue. By the time it is escalated it is too late and an "elastoplast" approach has to be made. Going back to point 2, if it was a requirement to have a process within a GP or hospital etc for the use of EMR in clinical trials (i.e. their SOP for their site) then monitors/sponsor staff could ask for this at Pre study visits and then use this as the basis for confirming if it was possible or practical to use the site.

    So, over a year on from the original poster's question - is there anything to add or are clinical trials and technoliogy still at odds?

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    I think that clincial trials and technology are still at odds!!!

    The issues are that their is no one generic electronic system that is used nationally individual hospitals have created their own electronic data capture system. For us a tthis site we still continue to print off source documents and get them verfied upon completion of the study we are then scanning back into the eletronic system and destroying paper copies.

    This issues still continues for us, as out site will not adapt the system to allow restricted access to patients data for monitors.

    If woudl be nice to have other comments on this issue.

  5. #5
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    Here are some good UK references if you are working in the UK:-
    The Good Practice Guidelines for GP electronic patient records v4 (2011) Department of Health (DH)/Royal College of General Practitioners (RCGP)/British Medical Association (BMA).
    Joint Guidance on Protecting Electronic Patient Information British Medical Association / NHS Connecting for Health.
    Records Management: NHS Code of Practice (2nd Edition) DH/Digital Information Policy.
    Electronic Health Records (EHR): Guidance for Community Pharmacists and Pharmacy Technicians November 2012.

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