Proposed Charter for OASIS Electronic Trial Master File (eTMF) Standard

["Zack Schmidt" <zs@sureclinical.net>]

SureClinical offers the following comments to the proposed charter for the OASIS Electronic Trial Master File (eTMF) Standard TC.  

[Comment 1] Section (1) (c) Scope of Work would be changed to the following: 

"To enable a broader time period for industry participation and input, the work will be divided into multiple versions.  In version one, the first deliverable will be limited to the technical eTMF model, including items 1), 2), 3) below related to the eTMF conceptual content model and eTMF data exchange model.   In version two and following versions, items 4) and 5) will be the focus.  In Version two and following versions, efforts will be made to develop a standards-based eTMF controlled vocabulary for use with the eTMF technical model defined in version one.   

1) We will gather, summarize and prioritize business and technical requirements from OASIS eTMF TC committee members, industry and academia for creation of a clinical trial content exchange format.   We will seek input during the initial stages of work from key industry groups including, but not limited to, CareLex, clinical trial sponsors, Document & Records Management DIA Community, NCI Thesaurus, SAFE-BioPharma, technology vendors, and TransCelerate BioPharma. Input will be incorporated into the general statement of need.
  
2) We will create and deliver an eTMF Content Model format that is:  1) Is Machine Readable, 2) Is based on web-standards such as XML or RDF/XML, 3) Can be imported/exported to and from relational database systems, file systems, content management systems and simple web sites; and that can be edited any simple text editor; 4) Can be viewed from within any major web browser; 5) Contains the eTMF Content Model Ontology schema in machine readable form  

3) We will create and deliver an eTMF Data Model format that is:  1) Is Machine Readable, 2) Is based on web-standards such as XML or RDF/XML, 3) Can be imported/exported to and from relational database systems, file systems, content management systems and simple web sites; and that can be edited any simple text editor; 4) Can be viewed from within any major web browser; 5) Contains the eTMF Content Model Ontology schema in machine readable form; 6) Supports inclusion of pointers to documents and their associated metadata records;  7) Enables exchange of documents in any state between systems; 8) Defines the status of the state of a content item (complete/incomplete; signed/unsigned); 9) Defines a core set of metadata for digital certificate signing (PKI x.509) of content items that defines details such as i) A link to the public key of a digital signer for identity verification; ii) digital signature time stamp details; other details as needed to validate the identity of a signer and the validity of a digitally signed content item.

4) We will create and deliver a content classification Ontology or Content Model that utilizes a core standards-based vocabulary and content classification hierarchy, a content classification specification that enables organizations to organize, classify, tag and archive clinical trial content using standards-based metadata with web-based standards for interoperability, while maintaining the flexibility organizations need to adapt to business and government requirements.    The content model shall include controlled vocabulary terms with relational links to term definitions that are published in NCI Thesaurus and other published vocabulary sources such as HL7, BRIDG, and CareLex. 

5) We will create a standards-based eTMF controlled vocabulary with terms that are taken from published sources such as BRIDG, CareLex, Dublin Core, HL7, National Cancer Institute online NCI Thesaurus, TMF Reference Model v2.0, and other academic, government or non-profit sources of clinical trial terms.  Terms that are deemed by the eTMF TC as core to the eTMF standard that are not part of any published vocabulary will be submitted by the OASIS eTMF Standard TC for inclusion in NCI Thesaurus."

[Comment 2]  The draft charter should modify the list of deliverables to be consistent with the scope, such that the deliverables will support the scope and nothing further.  Section 1 d)List of deliverables will be modified as follows:

"(1) (d) List of Deliverables

The TC has the following set of deliverables for Version One of the Standard:

- OASIS standards track eTMF core content classification specification (item 1 below) shall be completed by the TC within nine months after the initial TC meeting.  

A list of all deliverables includes the following:
1. An eTMF  Content Classification Specification that includes:   Architecture Diagram, eTMF Content Classification Ontology, Content Classification System Rules and Policies, Content Entities, Hierarchy and Numbering System, Core Metadata Definitions, Core Metadata for File properties, Basic audit trail, Classification, Business Process Modeling, Digital Signing and Content Item status; Ontology Content Types for the eTMF domain; Content Model Format;  Core Content Types for the eTMF domain that support FDA and ICH required regulatory documents taken from ICH and FDA publications; Core Metadata for the clinical trials domain needed to classify content by study, by site, by country, by date; eTMF Data Model and file format information; eTMF Data Model Viewing and Exchange; Non-Core:  Guidance for Use; Editing Content Models, Security Considerations. 
 
eTMF Content Model format
2. An eTMF Content Model format comprised of: 
  a) A core rules-based eTMF hierarchy with core content classification categories that supports FDA and ICH required regulatory documents;
  b) An eTMF Content Model database delivered in machine readable format such as RDF/XML.
c) Core metadata that supports Section (1) (c) Scope of Work items 1, 2, 3 in from published sources including only BRIDG, Dublin Core, FDA, HL7, ICH and NCI Thesaurus semantic concepts. 

3. An eTMF Data Model specification and file format that allows interoperability:  
  1) Support for export of clinical trial study document and record content (documents such as ISO-32000 PDF and web-standards based images) and records to a universal digital container format (such as .ZIP 64) consisting of a package containing simple file folders and XML text files; 
  2) Export of the Content Model for the exported documents and records using a machine readable format and contained in the universal digital container package;
  3) eTMF Data Model documents and records shall be viewable in major web browsers.
  4) eTMF Data Model and Content Management Interoperability Services (CMIS) standard integration points.
All other non-standards track and non-core deliverables within the scope outlined above will be delivered within twelve months after the initial TC meeting."