eTMF TC Charter comments

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

https://www.oasis-open.org/apps/org/workgroup/oasis-charter-discuss/email/archives/201311/msg00005.html

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."

-- 

Zack Schmidt, President
SureClinical 

Healthscience Applications

2865 Sunrise Blvd Suite 218
Rancho Cordova, CA  95742



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