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Thread: Requirements electronic archive

  1. #1
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    Nov 2011

    Requirements electronic archive

    As the sponsor we will receive an electronic TMF compiled by the CRO during a phase-3 study. What are the requirements regarding IT to be able to archive the TMF 'forever'. Would a server that automatically and regularly creates copies of the content be sufficient? Can the documents be in MS-Word or Excel or do they need to be pdf files? Will scanned signature pages count as originals? In what format should e-mail correspondence be archived? Where could I find some guidelines/guidance documents on the subject?

  2. #2
    Some guidance is available in "The Rules Governing Medicinal Products in the European Union" Volume 10 Clinical Trials. Chapter 5, Section 5 deals with electronic records. It emphasises the need to ensure that records are complete, accurate and legible across the whole retention period. Whilst MS-Word or MS-Excel are appropriate in the short term, it is likely that you would either need to migrate those records to newer versions of Microsoft Office over the coming years or migrate to an alternative format such as PDF/A. So, whilst MS-Office is not precluded, it does mean a potential migration issue for the future which PDF/A is unlikely to.

    The EMA and FDA have both published a definition for "certified copies" which are quite similar to each other. For scanned pages to be accepted in lieu of the paper, the images need to be generated as certified copies. This means introducing a quality management system that includes a check that the images are an accurate and complete copy of the original. Copies need to be certified by an appropriate individual; according to FDA guidance this may be on a document-by-document basis or in bulk (i.e. certify a batch of scanned documents).

    There seems to be differeing viewpoints in relation to format for emails. Saving in the native email format (e.g. Microsoft .msg format) preserves all of the metadata and permits access via the original software. However, as per the comments previously about software obsolescence, there is no guarantee that MSG files will be able to be opened for the lifetime of the record. It is for this reason that many choose to archive as PDF/A. Conversion to PDF/A does lose some metadata but following the principles of a risk-based approach, the loss of internet header information is generally considered to be acceptable. I am not aware of any agency inspectors refusing to accept PDF copies of emails on the basis that they are not a true copy of the original email. As for scanned copies, conversion of emails to PDF/A should be compliant with the requirements for a certified copy.

    In addition to the EU Volume 10 guidance, the Scientific Archivists Group have produced a guidance document "Guidance on the Archiving of Good Clinical Practice Material" which includes some information on electronic records. They currently have a working group who are developing guidance specifically on electronic archiving.

    As far as the archive media is concerned, I would advise against archiving the data on CD-ROM or DVD. These are genarally not suitable for lon-term retention. Ideally, you should create an electronic archive that has equivalent controls to those described in the regulations for a paper archive. The data would be routinely backed up, as per your standard IT backup processes.

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