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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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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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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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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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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 (or use the Template request Excel spreadsheet):
CDE Public ID (for reuse, if existing)
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