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 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.
Open the CDE Browser and click on the following:
CDASH, SDTM and Sponsor Defined Variables folders are displayed.
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.
If you use your mouse to hover over the CDASH or SDTM folder, you will see the latest version of content in caDSR, as shown in the picture below, “CDEs related to CDASH version 2…” When a new version of CDASH or SDTM is published, any new CDEs requests will be completed using the new version as a reference (unless otherwise requested) and the “mouse over” information will be changed.
The CDISC CDEs are curated as requested by the caDSR user community. Our first request was for the entire CDASHIG 2.0 metadata table and so the 658 variable CDEs were created, classified by their domains, and assigned CDASH Core (Highly Recommended, Recommended/Conditional and Optional). Later requests came for SDTMIG 3.3 variable CDEs as users wanted to make sure their CDEs were compatible with both their dataset submissions and data collection applications. We recommend that searches begin with the CDASH CDEs and then SDTM if you can’t find the variable you need.
The NCI CBIIT Curation Team (also known as the Curation Team) can add CDASH variables to the SDTM domain folders by request. Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following:
CDE Public ID
New Source Classification (CDASH or SDTM)
Domain (DM, AE, EX, etc.)
The Curation Team can create new CDEs for any model permissible, implementation guide, or therapeutic area guide variables.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following:
Source (CDASH or SDTM or Both)
Domain (DM, AE, EX, etc.)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
Yes. A non-standard variable is any variable outside of the Standard CDASH or SDTM variables found in the model or implementation guides and are included in Supplemental Qualifier (SUPP--) datasets for each domain at the time of data submission. In addition, CDISC has an established process to create a custom SDTM domain.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line. Include the following information for the new CDE:
Source (leave blank)
Domain (leave blank)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
Yes, a CDE is needed and the Curation Team can help. A sponsor defined variable is any variable outside of the Standard CDASH or SDTM variables found in the model or implementation guides and are included in Supplemental Qualifier (SUPP--) datasets for each domain at the time of data submission.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
Source (leave blank)
Domain (leave blank)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
The Curation Team can help you verify your search for an existing CDISC CDE and/or help you with creation of a new CDE, if needed.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
Your CRF question text, pick list values (if any) or data format (data type and maximum character length)
CDISC Observation Class and Domain that matches your expected data
While the term “custom variable” isn’t found in the CDISC CDASH or SDTM documentation, it’s often used to mean the same thing as a non-standard, supplemental qualifier, or sponsor-defined variable. At the time of submission, the data are included in Supplemental Qualifier (SUPP--) datasets for each applicable domain.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following:
Source (leave blank)
Domain (leave blank)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
Since FDA doesn’t mandate the format for collection of data, you can always use the same CDEs you’ve used in the past for these questions. At the time of data submission, the data will need to be transformed into the SDTM format.
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:
Source (CDASH)
Domain (IE)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
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.
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.
You can still continue to use the same CDEs you always have to collect your PRO questionnaire data since there are no FDA guidelines about the collection of data. However, CDISC develops SDTM QRS supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments for FDA data submission. The NCI CBIIT Curation Team is currently mapping the existing CDEs to these questionnaires and developing new CDEs where needed.
If I want to use CDISC compliant CDEs, how do I request them?
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
Questionnaire Name
Source with information concerning the applicable copyright or licensing restrictions
We will follow up with your request and let you know what CDEs exist or can be created.
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.
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.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line. You will need to provide the following information:
Source (CDASH or SDTM or Both)
Domain (DM)
Your CRF Question (CDE Preferred Question Text)
Proposed CDISC Variable label (CDE Long Name)
Proposed CDISC Variable name (CDE Short Name)
Data format (Data type and max length)
Your CRF List of values (if enumerated)
CDE Public ID for reference (if available)
The NCI CBIIT Curation Team can help you with requesting new values for an existing or new CDISC CDE for the CDISC CTs.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
Your CRF Question
Proposed response value(s)
Proposed Response value definition(s)
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.
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 can add values to a new or existing CDE for use with your EDC system.
Send an email to caDSR.RA@nih.gov with CDISC CDE in the subject line and include the following information:
CDE Public ID (for reuse, if existing)
Your CRF Question
Proposed response value(s)
Response value definition(s)
At the time of data submission, your study team can use sponsor defined terminology for the SDTM formatted dataset.