Clinical Study Protocol
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Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

Licenses

Page standards status: Informative

This Implementation Guide is concerned with implementation of the ICH M11 HARMONISED GUIDELINE CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP). There is content from CDISC and TransCellerate that is also relevant. Terminology used by ICH is held by the NCI Thesaurus.

The license terms under which this content is used is presented here:

ICH M11

HL7 Vulcan acknowledges that ICH is the copyright holder for the ICH M11 Harmonised Guideline CeSHarP.

Use of ICH M11 Section Headings and Fields within the mapping spreadsheet, the creation of FHIR Profiles representing the M11 structures and the representation of M11 terminology structures within FHIR value sets is under the terms of the custom license provided in the ICH M11documents. That text is reproduced here:

Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modification or translation of the original document is endorsed or sponsored by the ICH must be avoided. The document is provided "as is" without warranty of any kind. In no event shall the ICH or the authors of the original document be liable for any claim, damages or other liability arising from the use of the document. The above-mentioned permissions do not apply to content supplied by third parties. Therefore, for documents where the copyright vests in a third party, permission for reproduction must be obtained from this copyright holder.

CDISC

HL7 Vulcan acknowledges that ICH is the copyright holder for USDM.

USDM is a reference architecture produced by CDISC to be used by TransCelerate and "anyone who wishes to create conformant standards-based technologies, which produce or consume study definitions - source DDF-RA/README.md at v4.0.0 · cdisc-org/DDF-RA · GitHub".

The statement of license terms for use of USDM content is

Content based on DDF-RA (GitHub) used under the CC-BY-4.0 license.

The Implementation Guide makes NO changes to this content with the exception of copying content from the m11 mapping document. The actual mappings are not changed.

TransCellerate

The exact terms are to be determined.

NCI Thesaurus

Terminology in the M11 specification was authored by ICH and will be maintained by CDISC. The NCI Thesaurus itself has the following license terms:

NCI THESAURUS™ Terms of Use

The NCI Thesaurus™ is released under the Creative Commons Attribution 4.0 International license (CC BY 4.0).

The NCI Thesaurus™ is produced by the Enterprise Vocabulary Services group of the Center for Biomedical Informatics and Information Technology, National Cancer Institute, Maryland, USA.

The name "NCI Thesaurus" is trademarked. Only the NCI Thesaurus™ published by the NCI can be released under this name.

Please see https://creativecommons.org/licenses/by/4.0/legalcode for the terms of the CC BY 4.0 license.

Intellectual Property Statements

In addition to the above the following standard IP acknowledgements apply

This publication includes IP covered under the following statements.