Public review comments for etmf-v1.0-Metadata Vocabulary: Category 103 IRB-IEC Sponsor Communication

["Eldin Rammell, Rammell Consulting" <eldin.rammell@rammell.com>]

C115691              Column C (preferred term): Inclusion of the word “Sponsor” is not understood. How would this category be used within an Investigator Site File, for example (an ISF ide defined as part of the TMF)? This category is not restricted just to Sponsor documents. Furthermore, it is not understood why site-level documents are excluded from this category. Common industry practice is to classify all IEC/IRB documentation in a single category and to use metadata to define trial-level, country-level or site-level documents. The inclusion of sub-category 104.13 provides for site-level IRB/IEC documents but does not provide for country-level IRB/IEC documents.

 

The rationale for departing so widely from the commonly adopted TMF Reference Model classification is not understood and is likely to cause issues for implementation. It is assumed that any IRB/IEC document other than file notes, meeting materials and tracking documents will be classified as 103.10.10. At the trial level (excluding site-specific IRB/IECs) this includes: IRB/IEC submissions, IRB/IEC approvals, IRB/IEC decisions, routine updates to IRB/IECs, composition lists for IRB/IECs, IRB/IEC GCP compliance statements, notification of safety events to IRB/IECs, notification of trial termination to IRB/IECs. Classifying all such documents as T103.10.10 will not assist interoperability as users of the standard will want greater granularity for this content type.

 

 

Eldin Rammell

Managing Director, Rammell Consulting Ltd.