Zone 4 – IRB / IEC and other committees:
· All trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) are being considered a single artifact/content type – this will be a critical Regulator finding on Inspection as they will not be able to easily differentiate between submissions and approvals and communications, apart from with document level metadata. This goes against the principal of the TMF Reference Model – a model used and agreed between over 350 people now. The TMF Reference Model format must be followed for Industry standardisation. In addition, only single country studies have trial level IRB / IEC approval as an option, and then usually just single site
· All site-level IRB/IEC documents will be considered different content types to the equivalent trial-level IRB/IEC documents and classified within the Site Management zone rather than the IRB/IEC zone – this means there is no consistency in classification between site level IRB and country level IRB which will make searching far more complex. This could be a critical Regulator finding. The TMF Reference Model format MUST be followed as it is logical and agreed by over 350 people.
· There is no provision for country-level IRB/IEC documents – This goes against the basics of the clinical trial process as there is very often country level ethics committees. This needs to be broken down to separate artifacts as per the site level Ethics artifacts. This could be a critical Regulator finding.
· An “IRB/IEC-approved” ICF is considered a different artifact to the master ICF submitted to the IRB/IEC. The same applies to subject diaries, questionnaires, information sheets, subject participation cards etc. Approval of a document is more usually considered a property of the document (metadata) rather than changing the content or artifact type. This is completely unmanageable as a concept – version 1 will be finalised at a trial level, then maybe at a country level, then maybe at a site level. They will all be masters, they could all need EC approval. Approval would be an ongoing process, so documents would have to be copied from the master location to the approved location as they are approved. What happens if a trial master is approved at half the sites but not all sites? Does it go in the approved artifact? If it is stored at site level, you could have multiple copies of a single document being stored. I radically oppose this idea, it is totally unworkable in real life.
Karen
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