eTMF

["Malia, Joanne" <Joanne.Malia@pharma.com>]

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies – this was an important effort and to throw this consensus away for no apparent reason is inefficient and inconsiderate to those involved. 

 

My company has been successfully using the TMF Reference model for several years with all of our CROs.  Please consider the following

 

·         OASIS considers all trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) as a single artifact/content type.  IRB documents at the trial level contain several easily identifiable types of documents and they should remain broken out.

·         OASIS allows 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.  Please keep this as IRB documentation – as it is a specific category on its own.

·         OASIS has no provision for country-level IRB/IEC documents.  This is critical for global studies as certain countries have a central IRB for the study and local IRBs for the investigators.  They need to remain.  

·         OASIS needs to clarify the following 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.

·         OASIS must clarify the following  as sponsor and investigator study files must be clear – while many documents do overlap, the classification must be clear.The Site Management zone includes a section specifically for documents that relate to a specified site (“Investigator Documents”). This section contains 39 separate artifacts or content types. Outside of this section are listed other artifacts which are also site-specific i.e. inconsistent classification.

 

Thank you.    

 

Joanne S. Malia

 

Director,

Medical Research Process Management

Purdue Pharma, L.P.

One Stamford Forum

Stamford, CT 06901-3431

Tel. (203) 588-7569

Cell (203) 561-5571

E-mail joanne.malia@pharma.com