Destruction of Paper Patient Notes

[kate lees]

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

[CGW1981]

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).

[MHRA Super Moderator]

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

[LFar]

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

[MHRA Super Moderator]

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.