---
schema-version: v1.2.8
id: OASISeTMF-v1.0-CS01
title:
- content: Electronic Trial Master File (eTMF) Specification Version 1.0
  language:
  - en
  script:
  - Latn
  format: text/plain
  type: main
link:
- content: http://docs.oasis-open.org/etmf/etmf/v1.0/cs01/etmf-v1.0-cs01.html
  type: src
- content: http://docs.oasis-open.org/etmf/etmf/v1.0/cs01/etmf-v1.0-cs01.pdf
  type: pdf
- content: http://docs.oasis-open.org/etmf/etmf/v1.0/cs01/etmf-v1.0-cs01.docx
  type: doc
type: standard
docid:
- id: OASIS eTMF-v1.0-CS01
  type: OASIS
  primary: true
docnumber: eTMF-v1.0-CS01
date:
- type: issued
  value: '2016-10-25'
contributor:
- organization:
    name:
    - content: OASIS
    contact:
    - uri: https://www.oasis-open.org/
  role:
  - description:
    - content: Standards Development Organization
    type: authorizer
  - type: publisher
- organization:
    name:
    - content: OASIS Electronic Trial Master File (eTMF) Standard TC
    contact:
    - uri: https://www.oasis-open.org/committees/etmf/
  role:
  - description:
    - content: Committee
    type: authorizer
- person:
    name:
      given:
        forename:
        - content: Zack
          language:
          - en
          script:
          - Latn
      surname:
        content: Schmidt
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: SureClinical
        contact:
        - uri: http://www.sureclinical.com/
    contact:
    - email: zs@sureclinical.net
  role:
  - description:
    - content: Chair
    type: editor
- person:
    name:
      given:
        forename:
        - content: Aliaa
          language:
          - en
          script:
          - Latn
      surname:
        content: Badr
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: CareLex
        contact:
        - uri: http://www.carelex.org/
    contact:
    - email: abadr@carelex.org
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Jennifer
          language:
          - en
          script:
          - Latn
      surname:
        content: Alpert
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: CareLex
        contact:
        - uri: http://www.carelex.org/
    contact:
    - email: jalpert@carelex.org
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Rich
          language:
          - en
          script:
          - Latn
      surname:
        content: Lustig
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: Oracle
        contact:
        - uri: http://www.oracle.com/index.html
    contact:
    - email: rich.lustig@oracle.com
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Catherine
          language:
          - en
          script:
          - Latn
      surname:
        content: Schmidt
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: SterlingBio
        contact:
        - uri: http://www.sterlingbio.com
    contact:
    - email: cms@SterlingBio.com
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Zack
          language:
          - en
          script:
          - Latn
      surname:
        content: Schmidt
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: SureClinical
        contact:
        - uri: http://www.sureclinical.com/
    contact:
    - email: zs@sureclinical.net
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Airat
          language:
          - en
          script:
          - Latn
      surname:
        content: Sadreev,
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: SureClinical
        contact:
        - uri: http://www.sureclinical.com/
    contact:
    - email: airat@sureclinical.com
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Troy
          language:
          - en
          script:
          - Latn
      surname:
        content: Jacobson,
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: Forte Research Systems
        contact:
        - uri: http://forteresearch.com/
    contact:
    - email: troy.jacobson@forteresearch.com
  role:
  - type: editor
- person:
    name:
      given:
        forename:
        - content: Prabhat
          language:
          - en
          script:
          - Latn
      surname:
        content: Vatsal
        language:
        - en
        script:
        - Latn
    affiliation:
    - organization:
        name:
        - content: Next Docs
        contact:
        - uri: http://www.nextdocs.com/
    contact:
    - email: "///C"
  role:
  - type: editor
language:
- en
script:
- Latn
abstract:
- content: |-
    Publishes details of an interoperable content classification system with rules, policies and procedures for how electronic content can be shared and customized for clinical trials.  Machine readable, open standards-based technologies are used in a vendor neutral approach.
    Instructions on converting the eTMF schema spreadsheet to an OWL RDF/XML ontology are available from IEEE.
  language:
  - en
  script:
  - Latn
  format: text/plain
doctype:
  type: specification
editorialgroup:
- name: OASIS Electronic Trial Master File (eTMF) Standard TC
ext:
  schema-version: v1.0.1
technology_area:
- Content-Technologies