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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Submission of Data in CDISC Format to CBER

Process for Planning and Accepting CDISC SDTM and ADaM

Formatted Submissions in CBER 

 

Questions can be directed to CBER CDISC

 

Effective December 15, 2010

 SDTM and ADaM are being accepted for all BLA submissions

 

Amy Malla is the Point of Contact

for all CDISC related questions (timelines, pilot opportunities, etc) at CBER

PLANNING

  1. Sponsor/Applicant will obtain the SDTM and ADaM Planning Checklist
    • The template and example can also be accessed via the link under "Resources for You" on this page
  2. The Sponsor/Applicant should contact the Review Division and notify the RPM of the intent to submit SDTM formatted datasets.
  3. The Sponsor/Applicant will complete the checklist and include it in the meeting packet or email the completed form to the RPM assigned to the submission.
    • Any planning meeting can be the forum for these discussions (pre-BLA, end of phase 2, prior to pivotal study, etc.)
  4. Reviewers and the Sponsor/Applicant will come to an agreement on the Domains identified for the trial, variables placed in the SUPPQUAL domains and any custom Domains created by the Applicant/Sponsor.
    • Reviewers will ensure there are no alternative master domains to place the variables contained in the SUPPQUAL datasets
  5. Prior to regulatory submission the Sponsor/Applicant is requested to submit a DEMO via the test Gateway or CBER DCC (CD-ROM) a minimum of 3 separate submissions in order to ensure compliance to the SDTM standard as well as a valid define.xml
    • The Demo may be in conjunction with the eCTD Demo or may be an eCTD skeleton with the data and define file in the m5 folder and is executed in the test environment.
  6. Demo Planning
    • Create eCTD backbone containing the datasets, define.xml and Validation and Data Interpretation Report in the M5 folder according to eCTD specifications.
    • For paper submissions with electronic data the note CDISC Demo in the cover letter and send the CD-ROM to CBER DCC, attention Amy Malla, HFM-25
    • The number for all Demo's is 999999, submit through the Gateway test account.  Select SDTM submission to identify the Demo appropriately.
    • Email the core ID/receipt number to CBER CDISC and Yudha Rustaman
  7. The validation of the Demo will be reconciled by Amy Malla with the Sponsor/Applicant to ensure errors are resolved or explained as appropriate.
    • Sponsor/Applicants should be pre-validating their submissions.  CBER requests the Sponsor/Applicants include a Validation and Data Interpretation Report with both their Demo and their regulatory submission to provide the reviewers will additional detail on known issues with the data.  A link to an example of this report can be found below.
    • The Validation Report that is generated by the validation tool (OpenCDISC) will be sent to the submitter to enable resolution or acknowledgement of issues, as applicable.

 

SUBMISSION

  1. Sponsor/Applicant will document CDISC submission on their Cover Letter
  2. Submission may be received as an eCTD via the Gateway (data will be in the M5 folder, no change from what occurs today) or paper/CD-ROM to CBER's DCC
  3. For each study in the submission two of three of the following domains will be evaluated for visual conformance to the SDTM standard:
    • AE (Adverse Events), DS(Disposition) or EX(Exposure) datasets 
    • M5/datasets/study name/tabulations
  4. For each of the two datasets, there will be a visual inspection of the first four columns in the are in order, STUDYID, DOMAIN, USUBJID, --SEQ (where -- is either AE, DS or EX).
    • Clinical studies that meet these requirements will be treated as SDTM submissions.

 

VALIDATION

  1. OpenCDISC is the tool that will be used for validation
  2. Amy Malla will perform the validation
  3. The define.xml will be validated using OpenCDISC
    • If, the define.xml passes, SDTM datasets will be validated
    • If, the define.xml fails, SDTM cannot be validated until the define file is corrected.  The Sponsor/Applicant will be contacted to resolve the errors.
  4. The SDTM and define.xml will be validated together and reconciled to the Validation and Data Interpretation Report.  All unresolved errors will be discussed with the Sponsor/Applicant for clarification or resolution.
  5. Upon completion of the reconciliation of the Validation Report a memo will be written to document that either the data is acceptable or that the data requires correction.
    • If correction is required, the memo will document the issues and the correction expected.
  6. The memo and the Validation Report will be appended to the regulatory file.
  7. Amy Malla will send the RPM an email summarizing the results of the validation and any action required.
  8. The RPM will communicate the results of the validation to the Sponsor/Applicant by sending a copy of the Validation Report to the Sponsor/Applicant and scheduling a meeting, as required, to discuss resolution of issues.

REVIEW

  1. Review continues the same as it occurs today
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