Clinical trial info

[JGilbert-eLife]

Description

There are best-practice recommendations for capturing clinical trials on which the article is reporting, which include adding text (with tagging guidelines from JATS4R) to the end of an abstract (Any other clinical trial references that are present should remain as URL links in the text and should not be converted to references/citations or to a <related-object>).

User stories

Author

1. As an author I want to be able to add the details for a clinical trial to my abstract so that I can indicate that my work is reporting the outcome of that trial.
2. As an author, I want to be able to edit the clinical trial details in my abstract so that I can correct any errors.
3. As an author, I want to be able to remove the clinical trial details from my abstract so that I can correct any errors.

But what if . . . ?

Consideration

• Currently, SciELO is not following JATS4R recommendations on this. They instead tag all clinical trial numbers in the text using ext-links:

<p>Número de registro clínico:<ext-link ext-link-type="clinical-trial" xlink:href="https://clinicaltrials.gov/ct2/show/NCT00981734">NCT00981734</ext-link></p>

• eLife, however, is planning to implement the recommendation in the near future.

XML requirements

This information should be captured in a sec in the abstract. related-object should be used for each clinical trial.
An optional@content-type can be used on the related-object.
The source-id attribute must be used to identify the clinical trial registry.
The source-id-type attribute must be used to identify the type of ID provided in @source-id. The value of @source-id-type should be “crossref-doi” or “registry-name”, as appropriate.
The document-id attribute is required and must hold the clinical trial number as provided in the clinical trial registry.
The document-id-type attribute is required and must identify the kind of @document-id. The value must be either “clinical-trial-number” or “doi”.

<abstract>
...
<sec id="abs3-9">
  <title>Clinical trial registration</title>
 <related-object source-type="clinical-trials-registry" source-id="10.18810/clinical-trials-gov" source-id-type="crossref-doi" document-id="NCT02968459" document-id-type="clinical-trial-number" xlink:href="https://clinicaltrials.gov/show/NCT02968459">
     This study is registered with ClinicalTrials.gov as NCT02968459.
   </related-object>
 </sec>
</abstract>

JATS4R recommendation: https://jats4r.org/clinical-trials

Mock ups

Proposal