Patient Identifiers vs valid reports – MHRA

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  • #42677
    rita.bildoy@ge.com
    Participant

    Hello!

    One question regarding patient IDs for a valid report in the UK.
    As you will be aware of, EMA has a stricter approach than the FDA regarding patient IDs for a valid report:
    – while FDA considers a define # of patients to be sufficient proof that a patient exists (even if no other patient IDS like name initials, DOB, gender etc are available); EMA considers only reports to be valid if a standard patient ID is gathered.
    There was a question regarding this on our case processing team (based in the US) – after Brexit, does the MHRA align fully with the EMA regulations on this respect, or are they open to receive reports where just “a patient”; “3 patients” etc are identified? I do believe the Human Medicine Regulations fully align with the EMA on this respect, but wanted to gather others’ perspectives.
    Thank you!

    #42731

    hi, I have the same question,
    as per GVP module ,

    ” identifiable ” refers to the possibility of verification of the existence of a patient based on the available information.

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