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Thread: Use of colour to decipher correspondence

  1. #1
    Forum Member
    Join Date
    Mar 2019
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    Use of colour to decipher correspondence

    Colour printing is no longer available at our organisation.

    However, we are concerned that font colour is often used to attribute email responses between site and sponsor e.g. between CRA and site staff.

    We can request justified exceptions should there be a regulatory need, for example to ensure that emails can be deciphered

    We would be grateful for your thoughts.

  2. #2
    Dear Fachelray

    Further information is available in the MHRA Position Statement and guidance on Electronic Health Records which refers to black and white scanning and the expectations for clinical trial records.

    Link: https://assets.publishing.service.go..._Statement.pdf

    If you have additional queries following review to the guidance, please contact the Clinical Trials Helpline for a response via clintrialhelpline@mhra.gov.uk


    Kind regards,
    MHRA Moderator

  3. #3
    Forum Member
    Join Date
    Nov 2011
    Posts
    134
    Your organisation needs to come up with a fix. It is important that the email correspondence should be transparent and clearly available and understandable for audit and inspection. Strange that the email chain does not display who the responses are from and when. I think you are refereeing to the fact that inside the email there could be different coloured text. The latest EMA TMF final guidance will help you here. Your creation of a flat files of the emails by printing them out, loses all the meta data which is required to be retained. The guidance says that you should retain the meta data and that the emails should be available and understandable for audit and inspection. Keeping your emails in an electronic form would allow the colour difference to always be seen. Follow the advice in the EMA TMF guidance. Obviously the archiving of emails in a dynamic way and adhering the GCP archiving requirements, has its challenges. Your IT department may be able to help. Your question is a good example of where filing and archiving of emails should have been thought of from before the start of trial development (from the planning phase in fact). It also shows that printing out of dynamic files has real problems, and should be avoided if it cannot be guaranteed that all the meta-data, email chains and attachments are retained in a form that is easily readable, and readily accessible. The EMA guidance also gives advice about filing/archiving correspondence in such a way that it is readily available and accessible to someone looking at it that is not from your organisation (auditor or inspector).

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