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Subject: Public review comments for etmf-v1.0-csprd01: B.3 Annotation Properties


Comment type [editorial]

Impact [major]

The definition of ‘archive’ may be an accurate definition from a computer architecture perspective but it is not consistent with regulatory definitions, for example, the OECD definition of an archive (including the requirement for content to be under the control of a named archivist and suitable for long-term preservation of content). As this specification is to be used in a regulated domain, by professionals who understand the OECD, MHRA and EMA definition of an archive, the generic definition proposed should be avoided. The use of ‘archive’ elsewhere in this document must be avoided unless it corresponds with the regulatory meaning and definition of a GCP archive (e.g. see Repository definition).

 

Whether or not a code originated by CareLex or is pending review by CareLex is immaterial to this specification. Once agreed and published, all that matters is the code that needs to be used to uniquely identify the resource. There need only be two prefixes: codes that are included within the specification (e.g. commence with C) and codes which are not included in the specification (e.g. commence with Z). This specification is not a CareLex specification, NCI specification or TMF Reference Model specification; all codes and references to any such organizations within the coding system must be avoided.

 

Eldin Rammell,

Principal Consultant, Rammell Consulting Ltd.



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