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Comment #00633 - Clinical Trials - z39_96-2015.pdf (revision #1)

Comment 633
Addressed (Unresolved)
ANSI/NISO Z39.96-2015, JATS: Journal Article Tag Suite, version 1.1 (Revision 1)
Comment Submitted by
Caitlin Gebhard
2016-06-03 08:34:19

A publisher has recently asked us how they should tag clinical trial registration information from https://clinicaltrials.gov/. The text is typically a simple heading plus the registration number, e.g.,Trial registration: NCT02442440 (https://register.clinicaltrials.gov/).



How should this be tagged? I have seen some publishers tag this a <related-object>; others treat it as a footnote; and still others tag it as a section in their Abstract. JATS4R has marked this as a future topic of discussion, but I wonder if there are recommened practices from the Working Group here. Should there be a specific element for this information?



Thanks!

Submitter Proposed Solution
Ms. B. Tommie Usdin
2017-08-31 11:34:24

? Simple links to Clinical Trials may just be <ext-link>, while more complex links may need <related-object>. In the Index ?clinical trials? will be cross-referenced to both <ext-link> and <related-object>

Both of the following examples will be used in the documentation.

  • As an External Link ? The issue is not about tagging Clinical Trials, but tagging external links to clinical trials that identify the Clinical Trial registry and have a UID for the trial. This is just like any other link to a known resource. The identifier and the resource information are supplied in the attributes and the link display text is the element content. ? Trial registration:
    <ext-link ext-link-type=?clinical trials.gov? xlink:href=?NCT02442440?>NCT02442440</ext-link> (<ext-link ext-link-type=?uri? xlink:href=?https://register.clinicaltrials.gov?>https://register.clinicaltrials.go v</ext-link> ? ANSI/NISO Z39.96-2015 April, 2017 Action Items and Recorded Decisions Page 10
  • As a Related Object ? There are cases where you may need more metadata (for instance a clinical trial title, or a DOI) and a stronger association between an article and a clinical trial than a mere <ext-link>. The following proposal is based on the <related-object> element:
    <related-object link-type="clinical-trials-registry" content-type="pre-result" source-type="clinical-trials-registry" source-id-type="ISRCTN" source-id="ISRCTN69423238" xlink:href="http://dx.doi.org/10.1186/ISRCTN69423238"> <source>Spontaneous Urinary Stone Passage Enabled by Drugs</source> </related-object>

? Suggested values for related-?object/@content-?type are: ?pre-result?, ?result?, and ?post-result?.
? Suggested values for related?object/@source?id?type are:
?ANZCTR|ReBec|ChiCTR|CRiS|CTRI|RPCEC|EU-CTR|DRKS|IRCT|UMIN-CTR|ClinicalTrials|ISRCTN|PACTR|SLCTR?