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CDE Public ID for reference (if available)
9. I have an Eligibility Criteria checklist that has inclusion and exclusion questions. There’s an example dataset for the Trial Domain (TI) for Inclusion/Exclusion criteria in SDTM but it doesn’t capture any of the Yes/No data I’ll be collecting for the questions on my form. What do I do to make these CDISC compatible?
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CDE Public ID for reference (if available)
10. I want to be sure to use CDISC Standard CDEs for my data collection CRF but when I compare my form to the SDTM example dataset for submission, the formats are really different. I can see that SDTM uses a vertical approach or “normalized” to submission dataset format but I collect the data in a “flattened” or horizontal format in my eDC system. How can I find the best CDEs to use?
If you’re unable to modify your CRF to use the vertical structure of the SDTM dataset example, the best thing to do is to search for CDASH CDEs to match your CRF questions. If you can’t find a CDASH CDE, search for SDTM CDEs next. Sometimes the best solution may be to collect the data as you always have using your CRF and then transform and format the data at the time of submission using the SDTM example.
11. My CRF contains information that would be considered Personally Identifiable (PII) or Protected Health Information (PHI). Do I need to make the CDEs I’m using in my Electronic Data Capture (EDC) system CDISC compatible?
No. There are no CDISC standards, whether in CDASH or SDTM, for PII or PHI data. You can collect that data using the same CDEs you’ve always used or find applicable CDE standards to use in your EDC since you won’t be submitting that data to the FDA.
12. I’m using a Patient Reported Outcomes (PRO) quality of life questionnaire in my protocol. How can I make sure the CDEs I’m using are CDISC compliant/compatible?
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We will follow up with your request and let you know what CDEs exist or can be created.
13. I mapped my demographics questions to CDISC variables. I found some CDEs that match, but some that don’t. Can CBIIT verify my CDISC mappings are correct and if they can, suggest CDISC compatible CDEs?
The Curation Team can only verify that you have chosen the correct CDEs from the CDISC collection. We can’t perform mappings or confirm that you’ve chosen the correct variables for your CRF questions and responses.
14. Will CBIIT automatically create new CDISC compatible CDEs for the questions I couldn’t find in caDSR?
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CDE Public ID for reference (if available)
15. I have values in my list that don’t already exist in the CDISC Controlled Terminology (CT) value set when I looked in the EVS Term Browser.
a. How do I request additions to the CT value set?
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Proposed Response value definition(s)
b. How will new values be added to the CDISC compatible CDEs?
The Curation Team monitors EVS and is notified of the CDISC CT Package quarterly releases in the NCI Thesaurus. At that time, we check all existing CDE Value Domains and update the list of permissible values accordingly. Information is included in all CDISC CDEs associated with CT value sets to let you know the latest package that’s been applied.
16. I requested a new value for the CDISC coded terminology list but EVS/CDISC did not approve How do I add it to my form? How do I submit the data to FDA?
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At the time of data submission, your study team can use sponsor defined terminology for the SDTM formatted datasedataset.
