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Thread: ePRO system - not GCP/ MHRA compliant?

  1. #1

    ePRO system - not GCP/ MHRA compliant?

    Hi all,

    We would like to investigate using our current 3rd party ePRO capture system for MHRA regulated trials but would appreciate your thoughts on the below setup. We use a system for our academic trials where patients have the option to complete QoL data direct online. Data is stored within our institutions ringfenced server.

    Of concern,
    1. Site (or anyone) have no access to the response data. Data is extracted at the end of a study or for interim meetings, for sponsor viewing only.
    2. Once completed and saved by the pt, the data can not be amended by the patient (or anyone)

    Looking into GCP/ MHRA requirements, I am concerned this set up is not compliant.
    I would appreciate your thoughts.

    Thank you,
    Rebecca

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Posts
    176
    Not sure. Others might have some good ideas.
    The data from trial participants is maintained by the investigator and is under their control and only a copy is given to the sponsor. So the big question is does the PI have "control" over the data? Is there a signed agreement between the investigator and the provider who holds the data for the investigator? Does the investigator have oversight over that provider? Does the provider provide secure retention of the data for the required retention period and under GCP compliant conditions? Can the PI and the provider provide easily available and directly accessible availability for inspections? Has the provider got all the computer validation documentation easily available for inspection and retained for the full retention period?

    How are corrections/amendments to subject data (by the subject) handled? Is there a work-round of documentation for these corrections/amendment?

    There is lots of stuff on this on both the MHA websites (& blogs) and the EMA website (see other replies in the IT computer section of this forum).

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