@bwiernik and @adam3smith any input on what item type to use for clinical trials?

I would use Report for this.

@dhimmel and @agitter two quick questions that I thought you may have answers to:

1. Date: Clinical trials seem to have lots of dates; I'm currently using the "LastUpdateSubmitDate". Is this the date we would want in the citation or would we want "StudyFirstSubmitDate" or some other date? Here's an example of the date info available:

"StatusVerifiedDate":"March 2020",
              "OverallStatus":"Completed",
              "ExpandedAccessInfo":{
                "HasExpandedAccess":"No"
              },
              "StartDateStruct":{
                "StartDate":"February 6, 2020",
                "StartDateType":"Actual"
              },
              "PrimaryCompletionDateStruct":{
                "PrimaryCompletionDate":"February 25, 2020",
                "PrimaryCompletionDateType":"Actual"
              },
              "CompletionDateStruct":{
                "CompletionDate":"February 25, 2020",
                "CompletionDateType":"Actual"
              },
              "StudyFirstSubmitDate":"February 6, 2020",
              "StudyFirstSubmitQCDate":"February 6, 2020",
              "StudyFirstPostDateStruct":{
                "StudyFirstPostDate":"February 7, 2020",
                "StudyFirstPostDateType":"Actual"
              },
              "LastUpdateSubmitDate":"March 22, 2020",
              "LastUpdatePostDateStruct":{
                "LastUpdatePostDate":"March 24, 2020",
                "LastUpdatePostDateType":"Actual"
              }

2. Author: I'm using the "ResponsiblePartyInvestigatorFullName" if one exists and the "LeadSponsorName" if it doesn't. Is this standard / ok? It seems like the "LeadSponsorName" will sometimes be a company.

I looked https://www.who.int/ictrp/How_to_cite.pdf and https://blogs.uoregon.edu/annie/2017/10/25/clinical-trial-apa-format/ but they didn't seem to be conclusive.

For things like preprints, Zotero translators typically save the last updated date (i.e., the date of the version of the item actually being viewed) as the date. The first submit date could be stored in Extra with the label "Original date:"

Agree on the regular date, but I'd be careful with using original date too widely. Its most common use is for historical publication dates of reprinted works, which are often rendered in citation styles. I don't really see that that'd be true for clinical trials (or preprints, for that matter).

That's a really good point. "Submitted" might be a better (and rarely used in citation styles) variable.

I'm using the "ResponsiblePartyInvestigatorFullName" if one exists and the "LeadSponsorName" if it doesn't. Is this standard / ok? It seems like the "LeadSponsorName" will sometimes be a company.

Just looking at a random record NCT04291053:

            "SponsorCollaboratorsModule":{
              "ResponsibleParty":{
                "ResponsiblePartyType":"Principal Investigator",
                "ResponsiblePartyInvestigatorFullName":"Chen Xiaoping",
                "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
                "ResponsiblePartyInvestigatorAffiliation":"Tongji Hospital"
              },
              "LeadSponsor":{
                "LeadSponsorName":"Tongji Hospital",
                "LeadSponsorClass":"OTHER"
              }
            },

I think perhaps we want everything: the lead investigator, the sponsor, and collaborators. Each one of these could be different authors. I don't know too much about clinical trials however, so would be interested in what others think

Thank you all for the quick responses. Much appreciated!

My last commit attempts to incorporate that feedback.

• I'm including the initial submission date in extra.submittedDate
• I'm including the lead investigator, sponsor, and collaborators as creators and, as a way to be able to tell who is who, I'm also including this info in the extra section explicitly stating what type of creator they were.
  (there aren't many creatorTypes for report so I'm just listing everyone as an author but including this info in the extra's will let downstream analyses be able to untangle who was a collaborator vs. sponsor, etc.)

When I run the tests locally it says that the extra field doesn't match. Here's the testing output:

         -   "extra": {
         -     "submittedDate": "February 6, 2020"
         -     "responsiblePartyInvestigator": "undefined"
         -     "sponsor": "Gilead Sciences"
         -   }
         +   "extra": "[object Object]"

i.e. it's getting "[object Object]"

@adam3smith or someone else experienced with Zotero, any input on this?

Haven't looked at your code, but Extra needs to be a string with the different values newline separated. It looks like you have it as an array?

Thanks @adam3smith! That worked. All three test are now passing. Ready for review.

A few immediate comments:

1. I would enter submittedDate just as submitted. That is the actual CSL variable. This will make it accessible for citations if needed.
2. I would suggest not saving the same information in multiple places; that has a decent chance of producing unexpected results in citations. I'll defer to @adam3smith as to where Principal Investigators, other collaborators, and the lead sponsor should go. My intuition is that the Principal Investigator should be stored as Author, any collaborators stored as Contributor, and the Sponsor stored in Extra (and only in Extra) labeled "Sponsor:". Perhaps conditionally if there is no Principal Investigator, then Sponsor could instead be stored as an author.
3. Use proper narrative capitalization and spacing when storing data in Extra, rather than camelCase (e.g., Principal investigator: rather than nresponsiblePartyInvestigator:).
4. Undefined or missing values should be dropped rather than being stored as undefined
5. "ClinicalTrials.gov" should be stored in the institution (publisher) field, and "Clinical trial registration" in the reportType field.
6. The registration number (I think NCTId) should be stored in reportNumber
7. The BriefSummary part of the DescriptionModule should be stored in abstract