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Thread: Destruction of Paper Patient Notes

  1. #1
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    Destruction of Paper Patient Notes

    We are an NHS Trust that is going through the transition of paper notes to electronic, patients historical paper notes are being scanned into the electronic system. After the information is scanned in is it ok to destroy the paper records?
    Thanks

  2. #2
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    Destruction of Paper Patient Notes

    Scanning & destruction of original is a difficult problem and there are two places where helpful information may be found: the RQA (Research Quality Association, www.theRQA.com)) website and the MHRA GCP Guide (2012).

    RQA GCP website Q & A. Question:- Investigator Site Master File: conversion to electronic format.

    Answer: Electronic storage of GCP documentation is a continuing problem and has not been fully resolved as far as the RQA GCP Committee understands. Although there have been great advances made in setting standards for the storage of electronic data (21CFR Part 11, SAG, CDSIC, GAMP, etc) it is not yet certain if this is fully acceptable to GCP inspector of all inspectorates.

    One GCP inspectorate (UK MHRA) has replied to a similar question about scanning of SMFs on 11Sep2009:-
    “The EU Directives state that essential trial documents must be retained for defined periods. There is no mention of circumstances where they can be destroyed before the defined periods have elapsed. It is possible to transfer authenticated copies to other media, but it is the responsibility of the sponsor and chief investigator to ensure that the TMF (site and sponsor) is a complete and accurate collection of all essential trials. It would be their responsibility to demonstrate that this was so where they have allowed essential documents to be transferred to other media.”
    The MHRA had previously answered a question on scanning of the TMF (20 May 2005):
    Q. “Electronic storage of Trial Master Files – would the MHRA still require that paper copies be held in addition to the electronic records? A. If the original is generated on paper (e.g. requires a ‘wet’ signature), then paper originals are expected to be kept. However, the organisation may choose to perform a risk assessment for destruction of originals, whilst maintaining scanned electronic versions. The draft [now final] “Recommendation on the content of the trial master file and archiving (July 2006)” has been published as part of Eudralex Volume 10. This provides guidance on storage media to be used.”

    RQA GCP Committee recommendation:-
    GCP regulations & guidance stress that original documents should be retained securely and intact for the full duration of the retention period. There are many documents in the Site Master File where original documents would be difficult to replace with “certified copies” (electronic or paper) such as: - signed consent forms; signed agreements (& contracts); delegation of duties and signature logs; handwritten notes; original films or recordings; etc. Monitors, auditors and inspectors would be anxious to have access to original documents.
    Storage of electronic documents on an investigator’s server or hard disc would bring with it problems regarding its security and longevity. The system would have to be capable of being: confidential; secure; validated; have an audit trail of any changes; be securely backed up at regular intervals; and have a plan for long term storage (inc Disaster Recovery Plan) that ensures that the records can be fully readable (including the meta data) for the full length of the retention period. For some data this may be 15 years or longer if the sponsor requires. All data scanned would have to go through a thorough QC and validation process, so that the storage system only contained accurate, legible and complete copies of originals that are durable and readily available. At present, it is the RQA GCP Committees recommendation that it would be best to maintain original documents in the SMFs in their original form. Documents sent by the sponsor (or others) in an electronic format should be filed in a secure format (such as PDF files on a CD-ROM) along with the other SMF documents and kept readily available in case of audit or inspection.
    Documentation created in an electronic environment by the investigator/institution, should either have a fully validated system that can comply with all the requirements outlined above, or should have certified copies made on a durable media for long term archiving. Date: 11th November 2009


    A more current guide is the MHRA GCP Guide (2012) which says something similar.
    MHRA GCP Guide (2012) section 10.5.4 "When original paper TMF documents are transferred to an electronic format (or other media) the system of transfer must be validated in order to ensure that the transfer of documents is without loss and to ensure that certifiable copies are made (such that there should be a demonstrable 1:1 mapping between the content of the original TMF and the eTMF, which essentially means a QC check of the original TMF against the eTMF)". ........ "There is a move towards scanning of subjects medical records within the NHS and the same principles of ensuring authentic copies also applies to this situation, prior to any destruction of original source documents".
    Section 10.5.5 ".... early, complete destruction of such records is not currently recommended or should only be undertaken on a risk-adapted approach. .... "This indicates that the eTMF would contain some documents that are more likely to have the original paper copy requested than others, such as, agreements with wet ink signatures, signed letters. The current recommendation is to undertake a risk assessment so as to decide which documents do not need to be retained on paper, particularly focussing on whether or not the paper version could be obtained or not upon request (for example, reprinted or obtained from another location)".

  3. #3
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    If a MHRA moderator could provide a view on this it would be very useful, as this is happening at more and more NHS Trusts.

    We have been asked for our view as sponsor/monitor and currently we aren't 100% sure how to respond with anything more useful than asking them how they are validating the scans (i.e. how they are certifying the copies).

  4. #4
    To help clairfy expectation, please see a response from the MHRA:

    The MHRA GCP Inspectorate repeatedly receives forum posts and GCP queries via the clinical trial helpline about electronic health records (EHR) and eTMFs. So, this is a hot topic in GCP at the moment. There is extensive information on this in a number of places:
    1.MHRA GCP forum under the sticky notes for trial master file there are numerous Q&As regarding electronic records in particular questions 11, 12, 17).
    2.MHRA GCP Guide, in particular chapters for the TMF and investigator site.
    3.EU guidance on electronic data
    4.EU guidance TMFs

    The TMF and investigator documentation (including patient notes) are governed by the clinical trials legislation in the UK S.I. 2004/1031, and its subsequent amendments:
    1.Regulation 31A: regarding the trial master file, including the investigator documentation
    2.Schedule 1, part 2, principle 9: all clinical information shall be recorded, handled and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentially of records of the trial subjects remains protected.
    As such, the Sponsor and Chief Investigator shall ensure that the medical files and essential documents from the Trial Master File (TMF) are retained for at least 5 years after the conclusion of the trial. Please note, that some trial files (including medical records) may need to be retained for longer than 5 years in relation to other legislation (e.g. paediatrics, advanced therapies and marketing authorisation trials).

    However, the legislation does not say you cannot transfer to another media.

    Therefore, you may transfer to another media at any time and electronic copies are acceptable, provided, you can demonstrate that the copies were certified as accurate, complete, legible and retaining the meaning of the original document. There should also be security in place to ensure that such records cannot be changed and are supported by an audit trail (i.e. audit trail of who created and when and any audit trail of the amendment or deletion of the documentation). It should also be ensured that the system for the electronic archiving allows continuing access (taking into account media degradation, software/hardware changes and it is backed-up including test restores to ensure retrievability is maintained).

    However, our advice remains that it is recommended that you retain all original trial essential documents (including trial medical records) for the required retention time (as detailed above).

    Therefore, documents can be destroyed, but there must be confidence in the electronic system in order to do this. We have seen many issues with electronic systems whilst on inspection. As a result our advice remains that originals are retained for the required retention time (as detailed above). This is also in line with the EMA advice on his matter.

    We hope this helps clarify expectations as sponsor.
    MHRA Super Moderator

  5. #5
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    In order to provide further clarity, could an MHRA moderator please comment on the situation where some NHS Trusts are now stating that they will no longer be providing paper medical notes at all for new patients – everything will be on their local network.
    In this case, as Sponsor, would we have to insist that if they are entering patients into a trial they have parallel paper notes? Or ensure they have a system that can produce a report ?
    Many thanks for your response

  6. #6
    Electronic Health Records can either be scanned paper records or direct data entry/source data capture. However, it make no diference how the data is collected in terms of the expectations of GCP. The sponsor is responsible for identifying where the source data is captured and how they will perform source data verification. If the source data is electronic, then there must be provisions with the site about how the sponsor will access this data. This can either be by direct access, or as a certified paper copy. If it is the later the sponsor is responsible for verifying this a robust process to ensure the certified copies are complete and reliable. It is recommended you refer to the EMA reflection paper EMA/INS/GCP/454280/2010.

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