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These FAQs document some of the most frequently asked questions received from the caDSR user community as groups are working to implement the CDISC standards. Additional questions and answers will be added over time as they are asked received via the CADSR.RA@nih.gov email. In addition to the FAQs, an Excel template is included to assist requests for the creation of new caDSR CDEs that conform to CDISC standards and a brief presentation to guide the creation of new CDEs using the caDSR standard format.
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CDISC domains are located below the CDASH and SDTM folders. Click on the CDASH or SDTM folder icon to display folders for each domain. The CDEs are displayed by clicking on the domain name.
You can also search for the specific standard CRF modules using CDE Browser or FormBuilder by clicking on Protocol Forms and then the name of the standard CRF Template.
2. How can I tell what version of CDASH or SDTM is in caDSR?
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Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following (or use the Template request Excel spreadsheet):
Source (CDASH or SDTM or Both)
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Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line. Include the following information for the new CDE (or use the Template request Excel spreadsheet):
Source (leave blank)
Domain (leave blank)
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Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information (or use the Template request Excel spreadsheet):
Source (leave blank)
Domain (leave blank)
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Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information (or use the Template request Excel spreadsheet):
Your CRF question text, pick list values (if any) or data format (data type and maximum character length)
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Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following (or use the Template request Excel spreadsheet):
Source (leave blank)
Domain (leave blank)
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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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If you prefer, the Curation Team can curate new CDEs to match the SDTM formatted dataset. Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line. You will need to provide the following information (or use the Template request Excel spreadsheet):
Source (CDASH)
Domain (IE)
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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?
The Curation Team will not automatically create new CDEs. Once you’ve chosen the variables that map to your questions/responses and searched the existing content in caDSR, you can request to have the missing CDEs curated by the NCI CBIIT Curation Team or trained caDSR Curators can create their own CDEs following the guidance provided in the CDE Curation Basics for CDISC presentation.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line. You will need to provide the following information (or use the Template request Excel spreadsheet):
Source (CDASH or SDTM or Both)
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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?
If your requested value is not approved by EVS or CDISC for addition to the CT value set, you should receive information from CDISC about why it was rejected along with an alternative solution(s). You can still collect and submit that data. The NCI CBIIT Curation Team or trained caDSR Curators can add values to a new or existing CDE (owned by your Context) for use with your EDC eDC system.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
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At the time of data submission, your study team can use sponsor defined terminology for the SDTM formatted datasedataset.
