CDISC

CDISC ADaM Submission Recommendations

October 12, 2020

Regulatory Expectations

These Data Standards Catalogs from the FDA and PMDA show the valid ADaM-IG versions for your submission’s date.

  • FDA currently accepts ADaM-IG 1.0 and ADaM-IG 1.1.
    • Note: ADaM-IG 1.0 is only accepted for studies that began prior to the dates below. If your study started on or after these dates, then you can no longer use ADaM-IG 1.0 to submit that study.
      • 03/15/2019 for NDAs, ANDAs, and certain BLAs
      • 03/15/2020 for certain INDs
  • PMDA currently accepts ADaM-IG 1.0 only. Note: Unlike the FDA, the PMDA does not grant exceptions for issues in the Reject category.

CDISC ADaM Implementation Recommendations

September 28, 2020

Intro to ADaM Conformance

ADaM data are required by the FDA and PMDA, and accepted by China’s NMPA. Agencies often begin reviews with ADaM data validation, which helps them understand the analyses performed and reproduce results.

This is the first in a series of posts where we answer questions from our recent webinar, Exploring Common CDISC ADaM Conformance Findings. In this post, we focus on implementation recommendations.

Exploring Common CDISC ADaM Conformance Findings

September 16, 2020

In the regulatory review process, it's critical to have analysis data that comply with the CDISC ADaM standard. Both the FDA and PMDA require ADaM data, and as they begin reviews, they start with ADaM data validation. ADaM data help these agencies understand the analyses performed and reproduce the results for further validation.

In this webinar, Trevor Mankus covers the more commonly occurring validation rules and some potential reasons why they fired.