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Background

SENDIG-DART v1.1 Fit For Use Pilot is a CDISC SEND Team, FDA CDER, and Industry collaboration to evaluate the usability of the SENDIG-DART v1.1 standard for use in submissions of the Embryo-Fetal Developmental Toxicity studies.

This pilot, as described in the FRN, Docket Citation 85 FR 67355, Docket No. FDA-2020-N-1806 (see below), was open to the public to apply for participation.

One of the main tenets of an FDA Fit for Use Pilot is that feedback and learning by each pilot participant will be shared with the public broadly.  This wiki site is made publicly accessible for that purpose and will be shared in multiple forums beginning in May of 2022.

Learning from this pilot is intended to inform industry improvement efforts and will be incorporated in the next major version of the SENDIG.

Shared Learnings


  • Summarized Learnings:

 


  • Individual Participant Feedback / Take-Aways (participant questionnaire responses):

.  


  • FDA Feedback:

     


  • Individual Participant Submission Packages (Anonymized / Redacted):

Participant zip files (6 participants)

Reviewer Feedback:
  • PTOX Study Review Document

KickStart Session Documents:

  • Data Fitness Summary
  • KickStart Session Report 
  • Outputs – Janus
  • Outputs - SEND Explorer

Submission Documents (anonymized / redacted):

  • SEND Datasets (.xpt, .csv, or .xlsx)
  • nsdrg 
  • define-xml
  • Study Report
  • Study Protocol
DART FFU (P2).zip
DART FFU (P3).zipDART FFU (P4).zip

DART FFU (P5).zip

RptAudited_Redacted_CDISC (P5)-Part2.zip

RptAudited_Redacted_CDISC (P5)-Part3.zip

DART FFU (P6).zip
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