Regulatory Focus™ > News Articles > 2019 > 8 > CDER Plots Pilot Project to Test CDISC Standard

CDER Plots Pilot Project to Test CDISC Standard

Posted 19 August 2019 | By Zachary Brennan 

CDER Plots Pilot Project to Test CDISC Standard

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday said it will conduct a small pilot project to test the processing and analysis of nonclinical study data provided electronically using an updated standard, known as the SEND 3.1, from the Clinical Data Interchange Standards Consortium (CDISC).

CDER is seeking a maximum of five participants for the pilot, which will evaluate the compliance of sample SEND 3.1 datasets submitted to CDER.

FDA notes that studies initiated after 17 December 2016 must be submitted with data according to data standards listed in the FDA Data Standards Catalog for new drug applications, biologics license applications and abbreviated new drug applications. For investigational new drug applications, the requirement applies to studies initiated after 17 December 2017. “SEND 3.1 is included in the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future,” the agency said.

The pilot will involve the submission of a nonclinical study package containing the following materials:
  • SEND 3.1 datasets
  • Sample related study report (PDF format)
  • Nonclinical Study Data Reviewers Guide
  • Define.xml (v2.0)
  • Sample standardized study protocol
“CDER will prioritize nonclinical packages that highlight the most significant changes from SENDIG 3.0 to SENDIG 3.1,” CDER said, noting that potential pilot applicants should be submitting studies that meet as many of the following criteria as possible:
  • “Toxicology studies with safety pharmacology data that demonstrate appropriate use of:
    • Continuous data typically included in these safety pharmacology studies:
      • Cardiovascular data represented in the Electrocardiogram (ECG) Test Results Domain, Electrocardiogram Domain (EG), and the Cardiovascular Test Results Domain (CV).
      • Respiratory data in the Respiratory Test Results Domain (RE)
    • Timing variables for Planned Start of Assessment Interval (--STINT), and Planned End of Assessment Interval (--ENINT) (in the use of timing variables in the EG domain).
    • Unscheduled Flag, (--USCHFL) variable.
    • Nominal Study Day for Tabulations, (--NOMDY), Label for Nominal Study Day, (-- NOMLBL) variable to group and label data for reporting purposes.
    • Study data from a study or studies using the Latin Square design.
  • Toxicology studies including Pharmacokinetic Concentrations Domain (PC) and Pharmacokinetics Parameters Domain (PP) domains.
  • Toxicology studies with study data using controlled terminology (version 2018-03-30 or later) for:
    • Severity.
    • Non-neoplasm (NONNEO) using code list NONNEO and Microscopic Domain (MI).”
Pilot participants also commit to publicly share lessons learned with the CDISC SEND team to ensure that the CDISC SEND standard is improved moving forward, CDER said, noting that sensitive information can be redacted as needed.

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe