Public review comments for etmf-v1.0-Metadata Vocabulary: Category 108 Vendors

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

108                      The term “third parties” is more usually used. The term “vendor” implies provision of a product or service in exchange for financial reward. Whilst this is often the case, it need not necessarily be the case for the provision of trial-related services. Third parties is a more neutral term, implying any party other than the sponsor and investigator. It is the term adopted by the TMF Reference Model.

 

108.10.10            This content type includes a wide range of documents. Consideration should be given to providing greater granularity to better reflect best practice in industry. For example, initial evidence of vendor qualification could be differentiated from ongoing activities to confirm oversight of the services provided by the third party 9e.g. visit reports, quality questionnaires).

 

108.11                 The subcategory name is too ambiguous. In addition, the definition is not clear viz. agreement between vendor and CRO or between vendor and sponsor.

 

Eldin Rammell

Managing Director, Rammell Consulting Ltd.