Re: [members] Proposed Charter for OASIS Electronic Trial Master File (e

Subject: Re: [members] Proposed Charter for OASIS Electronic Trial Master File (eTMF) Standard TC

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Peter Alterman, Ph.D.

Chief Operating Officer
SAFE-BioPharma Association

cell: 301-943-7452

On Fri, Oct 25, 2013 at 2:27 PM, Chet Ensign <chet.ensign@oasis-open.org> wrote:

OASIS Members:

A draft TC charter has been submitted to establish the OASIS Electronic Trial Master File (eTMF) Standard Technical Committee. In accordance with the OASIS TC Process Policy section 2.2: (https://www.oasis-open.org/policies-guidelines/tc-process#formation) the proposed charter is hereby submitted for comment. The comment period shall remain open until 11:45 pm ET on 11 November 2013.

OASIS maintains a mailing list for the purpose of submitting comments on proposed charters. Any OASIS member may post to this list by sending email to: oasis-charter-discuss@lists.oasis-open.org. All messages will be publicly archived at: http://lists.oasis-open.org/archives/oasis-charter-discuss/. Members who wish to receive emails must join the group by selecting "join group" on the group home page: http://www.oasis-open.org/apps/org/workgroup/oasis-charter-discuss/. Employees of organizational members do not require primary representative approval to subscribe to the oasis-charter-discuss e-mail.

A telephone conference will be held among the Convener, the OASIS TC Administrator, and those proposers who wish to attend within four days of the close of the comment period. The announcement and call-in information will be noted on the OASIS Charter Discuss Group Calendar.

We encourage member comment and ask that you note the name of the proposed TC (eTMF) in the subject line of your email message.

=== Charter

(1) Proposal for OASIS Electronic Trial Master File (eTMF) Standard TC

(1) (a) Name of the TC

OASIS Electronic Trial Master File (eTMF) Standard Technical Committee (TC)

(1) (b) Statement of Purpose

The purpose of the OASIS eTMF Standard Technical Committee (TC) is to define machine readable formats for BioPharma clinical trial master file content interoperability and data exchange to include:

1) An eTMF content classification model comprised of a standards-based vocabulary and content classification ontology;
2) A set of eTMF content classification rules and policies;
3) An eTMF Data Model and format for the interoperable exchange of electronic trial master file information for the clinical trials domain, whereby eTMF content can be exchanged and viewed, e.g. in web browsers.

Problem to be solved:

As clinical trial stakeholder organizations seek to move from paper-based research to electronic approaches, information interoperability, information standards and agency compliance are key factors in accelerating the safe delivery of therapies to patients globally.

In order to move clinical trial content from paper-based approaches to automated electronic content management systems (CMS), a standardized, machine-readable content classification system with a standards-based, controlled vocabulary is needed. For those without access to CMS systems, a method to exchange, view and navigate content offline is needed. Today there is no standard that defines how eTMF data (content items such as documents, images, and record data) should be formatted for electronic exchange. To maximize interoperability, an open systems approach that is operating system independent, software application independent and computer language independent is required. Finally, any system must support government agency requirements that help raise the effectiveness, efficiency and safety of clinical trials, and must support long-term electronic archiving of content in standards-based formats.

(1) (c) Scope of Work

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.

2) 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.

3) We will create a standards-based eTMF controlled vocabulary with terms that are taken from published sources such as National Cancer Instituteís online NCI Thesaurus, HL7, BRIDG, CareLex and other academic, government or non-profit sources of clinical trial terms. Terms that are deemed by the eTMF TC as ëcoreí 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.

4) 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.

The TC will accept as input the following public specification:

-CareLex Model Specification, V1.03, Published June 27 2013
http://carelex.org/downloads/

-CareLex eTMF Content Model Database, V 1.02, June 9 2013 - RDF/XML format (.OWL)
http://carelex.org/downloads/ and http://purl.bioontology.org/ontology/CareLex

-CareLex eTMF Content Model Spreadsheet, .XLS Format, V1.02, June 9 2013
http://carelex.org/downloads/

- Other contributions will be accepted for consideration without any prejudice or restrictions and evaluated based on technical merit in so far as they conform to this charter and the IPR guidelines of the TC.

The TC will refine these initial contributions to produce OASIS standard specifications, including necessary supporting documentation.

The scope of the TC's work is limited to technical refinements to the features defined in the input contributions and the following features and capabilities.

The features in scope for the TC have been divided into the following categories:

1. Core Technology Architecture
2. Content Classification System
3. Metadata Vocabulary and Core Content Types

4. Data Model
5. Guidance for Use
6. Future Enhancements

The TC will focus on delivering the core specification first, as outlined below. The team will work on the Core Technology Architecture first, followed by the Content Classification System, (including any necessary changes to core), followed by Metadata Vocabulary and Core Content Types, Content Model Format, Data Model Format, Guidance for use, not precluding parallel work.

Core Specification: eTMF Content Classification Specification

1. General Requirements Statement of Need

2. Core Technology Architecture
2.1. Description of the Architecture

2.1.1. Web Standards support
2.1.2. Digital Signature support
2.1.3. Business Process model support
2.1.4. Export / Import formats

3. Content Classification System

3.1. Classification Categorization
3.1.1. Content Entities, Hierarchy and Numbering System
3.2. Metadata Definitions
3.2.1. Core Metadata
3.2.2. Domain specific Metadata

3.2.3. Organization Specific Metadata
3.2.4. General Metadata
3.3. Content Model
3.3.1. Content Model Format
3.3.2. Content Model Exchange

4. Metadata Vocabulary and Core Content Types
4.1. Core Content Types for the eTMF domain
4.2. Core Metadata vocabulary for eTMF domain
4.3. Optional Metadata vocabulary for the eTMF domain

5. eTMF Data Model
5.1. eTMF Data Model Format
5.2. eTMF Data Model Viewing using Web Browsers
5.3. eTMF Data Model Exchange
5.4. Interoperability with the Content Management Interoperability Services (CMIS) standard

5.5. Supported Document and Record Exchange methods

6. Guidance for Use
6.1. Content Model Editing and Modification
6.2. Creating and submitting new Metadata vocabulary terms

6.3. Security considerations

Out of Scope

The following is a non-exhaustive list provided only for the sake of clarity. If some function, mechanism or feature is not mentioned here, and it is not mentioned as in-scope in the Scope of Work section, then it will be deemed to be out of scope.

The following items are specifically out of scope of the work of the TC:

* Mapping to models, representations or protocols not scoped above
* Adding classifications that are not related to the clinical trial regulatory document domain to the content model, data model, vocabulary or content type definitions;

* Extending beyond the scope described above
* Defining mechanisms for authentication, encryption, security, cross-origin access;
* Attempting to maintain backward compatibility with external applications, systems, schemas or models.

* Contributions to this TC which are out of scope for this charter may be accumulated and taken into consideration for potential development of a charter for another technical committee that may be created to address future extensions or modifications to the eTMF Standard.

(1) (d) List of Deliverables

The TC has the following set of deliverables:

- OASIS standards track eTMF core content classification specification (item 1 below) shall be 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, Metadata Definitions, Metadata Vocabulary, Ontology Content Types for the eTMF domain; Content Model Format; Core Content Types for the eTMF domain; Metadata vocabulary for the eTMF domain; eTMF Data Model and file format; eTMF Data Model Viewing and Exchange; Non-Core: Guidance for Use; Editing Content Models, Security Considerations

2. An eTMF Content Model Ontology comprised of:
a) A core eTMF Vocabulary and metadata using standards-based terms;
b) A core rules-based eTMF hierarchy with content classification categories;

c) An eTMF Content Model database delivered in machine readable format such as RDF/XML.

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 PDFís 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.

Maintenance

Once the TC has successfully produced the deliverables, the TC will enter into a maintenance mode. The purpose of the maintenance mode is to provide minor revisions to previously adopted deliverables, in order to clarify ambiguities, inconsistencies, and obvious errors. The maintenance mode will not functionally enhance a previously adopted deliverable, or extend its functionality.

(1) (e) IPR Mode

This TC will operate under the OASIS Non-Assertion IPR mode. See https://www.oasis-open.org/policies-guidelines/ipr#s10.3 mode as defined in the OASIS Intellectual Property Rights (IPR) Policy.

(1) (f) Anticipated Audience

The anticipated audience for this work includes:

* Vendors and service providers offering products that produce data services

* Vendors and application developers who consume data services
* Software architects who design, write and deploy data producers and/or consumers
* End users implementing solutions that require an interoperable solution for exchanging clinical trial electronic content

* Regulatory agencies responsible for monitoring clinical trial regulatory compliance
* BioPharma clinical trial sponsors, clinical trial research organizations, consultants and industry stakeholders

(1) (g) Language

TC business will be conducted in English. The output documents will be written in (US) English.

(2) Non-normative information regarding the startup of the TC

(2) (a) Similar or Applicable Work

The CareLex eTMF model submitted for initial consideration utilizes the following:

* W3Cís XML, RDF/XML and OWL Semantic technologies

* The TMF Reference Model, a public domain list of content types for the clinical trials area
* Public domain Metadata vocabularies from HL7, the National Cancer Institute, and Dublin Core
* ISO 32000 PDF specification

(2) (b) Date, Time, and Location of First Meeting

The first meeting of the OASIS eTMF TC is tentatively scheduled for Monday December 16, 2013 from 9 AM PT to 10.00 PM Pacific Time. This meeting will be conducted via teleconference call and web screen sharing.

(2)(c) On-Going Meeting Plans & Sponsors

It is anticipated that the eTMF TC will meet via teleconference every other week for 60 minutes at a time determined by the TC members during the TC's first meeting. It is anticipated that the eTMF TC members will not be required to attend face-to-face meetings. The eTMF TC may change the time, frequency and dates of meetings.

Sponsorship for the meetings will be circulated among the members.

(2)(d) Proposers of the TC

Proposers of the eTMF Standard Draft Charter:

Zack Schmidt, info@SureClinical.com, SureClinical
Aliaa Badr, abadr@CareLex.org, CareLex
Eldin Rammell, eldin.rammell@rammell.com, Individual member

Catherine Schmidt, info@sterlingbio.com, Individual member
Louis Chappuie, lchappuie@gmail.com, Individual member

(2)(e) Statements of Support
"I, Zack Schmidt, info@SureClinical.com, as OASIS primary representative of SureClinical, confirm our support for this charter and endorse our proposers listed above as named co-proposers.

"I, Aliaa Badr, abadr@CareLex.org, as OASIS primary representative of CareLex, confirm our support for this charter and endorse our proposers listed above as named co-proposers.

(2)(f) TC Convener

The TC Convener for the first meeting will be Zack Schmidt from SureClinical

(2)(g) Affiliation to Member Section

None

(2)(h) Initial contributions:

-CareLex Model Specification, V1.03, Published June 27 2013
http://carelex.org/downloads/

-CareLex eTMF Content Model Database, V 1.02, June 9 2013 - RDF/XML format (.OWL)
http://carelex.org/downloads/ and †http://purl.bioontology.org/ontology/CareLex

-CareLex eTMF Content Model Spreadsheet, .XLS Format, V1.02, June 9 2013
http://carelex.org/downloads/

-CareLex eTMF Standards logo, Sept 3 2013

http://carelex.org/downloads/

-eTMF Standards FAQ
http://carelex.org/etmf-standards/

--

/chet
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Chet Ensign
Director of Standards Development and TC Administration
OASIS: Advancing open standards for the information society
http://www.oasis-open.org

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