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Thread: ePRO eCOA questionnaire

  1. #1
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    ePRO eCOA questionnaire

    Hi, we are setting up a trial and want to understand if we can ask the patient to provide with their email addresses/mobile phone numbers so that their user accounts can be created on ePRO / eCOA devices. The vendor would also use the same contact details in order to contact the patients if they missed any of the visit or questionnaires.

  2. #2
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    Quote Originally Posted by VBZ View Post
    Hi, we are setting up a trial and want to understand if we can ask the patient to provide with their email addresses/mobile phone numbers so that their user accounts can be created on ePRO / eCOA devices. The vendor would also use the same contact details in order to contact the patients if they missed any of the visit or questionnaires.
    Think about it - how will you maintain subject confidentiality/anonymity if you have access to a list of their contact email and phone numbers?

  3. #3
    Would this be okay if state in protocol that the ePRO sponsor admin have access to patient contact details in case of emergency?

  4. #4
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    I think we may be looking at this from the wrong perspective.

    Look at the MHRA GCP Guide (2012) and other replies on this forum.
    For instance you asked a similar question on 7th May 2022 about ePRO system - not GCP/ MHRA compliant? See reply to that.

    We have to think about the flow of data; who has “control” of that data; what explicit consent has been given for that data (& whether that data includes Personally Identifiable Information (PII) or not) ; GDPR; etc

    Your question about the protocol does not really touch the issue.

    If you read the MHRA GCP Guide you will see that the MHRA (Unlike some EU inspectorates) does allow personally identifiable information (PII) to be held by others than the investigators, provided that there is explicit consent of the subjects; that the IRB/IEC has explicitly approved of this process; and that Data Protection legislation & guidelines are complied with.

    If you look on the EMA IWG GCP webpages you will see that they are much more conservative about allowing PII data to be held by the sponsor or the sponsor’s agent (CRO or vendor).

    In fact a whole book could be written about this topic, but I lack the time.

    Best to be on the conservative side in my opinion.
    Your job is to comply with GCP and DP requirements. So generally it is the investigator who should have “control” and oversight of the subjects PII (Obviously with the full consent of the subject). Generally the Sponsor and the sponsors agents (Vendors etc) may provide the finance and logistics for these systems, and receive anonymised or psydoanomised data from those systems, but they never have their hands on the PII.

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