Good Clinical Practice Guide
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Thread: Electronic archiving of ISFs and E-CRFs

  1. #1
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    Electronic archiving of ISFs and E-CRFs

    As a host site we only have a contract and facilities for hardcopy archiving. Sponsors often send our site's ECFs, EDC etc on a CD for archiving. It is not feasible to print these document out as they exceed 1500 per patient (as it includes full audit trails for each participant's data points).

    The MHRA's position statement is (there should be) '
    Appropriate archiving to ensure long term reliability, retrieval and reproducibility of electronic data (and metadata), in line with regulatory storage timelines (note this will be 25 years as standard under the new Clinical Trials Regulation 536/2014);

    Is it reasonable for our archiving SOP to state that site staff print off the E-CRF pages and archive these but NOT the audit trails as this will reduce the number of pages to ~150 per patient. Is this adequate to ensure that we have archived the PI's essential documents and source data if we have assurance from the sponsor that they have long term reliability, retrieval and reproducibility of electronic data (and metadata)?


  2. #2
    It is expected that both the data and associated metadata (audit trails) are retained and archived by the Investigator to ensure that they maintain their own independent copy of the trial data.

    There is no requirement to have to print out all the eCRFs and audit trail data and this could use up extensive storage space. Electronic archiving and archiving of discs is acceptable, however the organisation should have a process in place to ensure that the data can be retrieved and is still readable. Therefore, options include periodically retrieving the disc from the archive to check that the disc still works and the data can be read. If during these reviews it becomes apparent that the storage medium may become obsolete, then consideration should be given to storing the data in another format which can be read (any transfer of data to a different media/ format should be a validated process which is fully documented). Other options may include ensuring that hardware and software is retained in order to view the data in the future.

    In summary, the regulations don't specify how this is to be done and it is recommended that a risk assessment is performed of the data and storage format, and a process developed to ensure it can be retrieved (and is periodically tested) during the archival period.

    The process used should be clearly described in a SOP and documented.

    Further information is available in Section 10.7.9 of the MHRA GCP Guide.

    Kind regards,
    MHRA Moderator

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