Public review comments for etmf-v1.0-Metadata Vocabulary: General

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

C115785              Please use ICH definition of a trial master file.

 

C115784              Please use ICH definition of a trial master file.

 

C114548              It is not understood why this term is included within the vocabulary. It adds nothing other than to provide an opportunity to promote CareLex.

 

C114463              The definition provided will lead to confusion. GCP regulations also use the term “archive”, “archiving” and “archivist” to have a very different meaning. An archive is a repository that is designed specifically for the long term retention and preservation of records and is NOT a general digital file store.

 

C114457              Please avoid using the word “archive” in this context for the reason provided above.

 

C25164                To facilitate interoperability, the date format should be mandated and not be a recommendation only.

 

C80447                No detailed specification provided for digital signature? No detailed specification provided for electronic signature?

 

C25341                The need for this attribute for interoperability is not understood or explained within the specification.

 

C29862                Requires standards to be defined to facilitate interoperability. The status of an object in the destination system must be identical to the status of the object in the source system.

 

 

Eldin Rammell

Managing Director, Rammell Consulting Ltd.