Good Clinical Practice Guide
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Thread: Trial Master File in SharePoint

  1. #1
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    Nov 2011

    Trial Master File in SharePoint

    In our Pharma Company we receive SharePoint, an internet platform where we file all our documents with metadata. The trial master file of a clinical trial will not be in the usual file structure but each document saved with its own metadata in a 'huge pot'. The guidelines say that the documents need to be filed in an 'organised way'. Is SharePoint suitable for archiving a TMF in the way described?

  2. #2
    In my view, absolutely!! By implementing a structured metadata approach, you are actually creating a system of organisation and therefore complying with the regulatory requirement to file in an organised way. Increasingly, IT vendors are moving away from the traditional hierarchical folder approach that mimics the paper file structure and moving towards the use of structured metadata to organise electronic documents. If required, your system actually allows you to present the eTMF content in a folder structure by defining specific SharePoint views based on selected metadata. However, your approach offers much greater flexibility because it allows the user to search for and locate documents based on a much larger number of parameters.

    A paper file system is only "organised" because it has cardboard index pages to delineate metadata groupings. Take away the index dividers and the file is disorganised. Your SharePoint "big bucket" is just like the paper file without the index dividers but you have instead provided a number of different types of index dividers depending on how users want to view the documents. In my opinion, your approach is a better approach! The only caveat to my comments is that search and retrieval depends to a much greater extent on the continued availability of the document management software (SharePoint in this case). Consideration should be given to long-term accessibility over the retention period of the eTMF content. Perhaps archiving at a defined time point in the future to a more traditional flat-file structure might be appropriate?

  3. #3
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    Jan 2012
    One quick question: would this approach, as described by DG01, need to be a validated "system" as per CFR Part 11 (assuming use in the US)? I understand that some eTMF technologies use a Sharepoint platform and include mechanisms for ensuring regulatory compliance. But would a "homegrown" Sharepoint solution be suitable if one needed to ensure all the checks and balances involved in validation, change management, etc.? I ask this because the exact solution described by DG01 has generated some interest in my global department. Thank you.

  4. #4
    Any solution - including homegrown ones - would need to be validated. An in-house build would take more effort to validate than an off-the-shelf Sharepoint-based system. However, I have seen in-house Sharepoint systems be validated, as per 21CFR11, FDA guidance on use of computerized systems in clinical trials and the EU guidance "Good Practices for Computerised Systems in Regulated GxP Environments".

  5. #5
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    Mar 2012
    I agree with rammellconsult. We have implemented Sharepoint numerous times. I like the analogy of the index dividers and that yiou have indeed created many other types of "index dividers" so the files can be found quickly and efficiently. The beauty of Sharepoint and correct assignment of metadata. I'd be interested to learn more about the homegrown variants of sharepoint deployments though.

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