October 2020

Preparing CDISC Submissions for China’s NMPA [Updated]

October 30, 2020

(Originally published on October 6, 2020. Last Updated on October 30, 2020)

Effective October 1st, 2020, China’s NMPA will accept CDISC submissions. To support this initiative, Pinnacle 21 has released a new Chinese-language validation engine, available now in both Enterprise and Community. This engine supports datasets with Chinese-encoded characters and displays rule messages and descriptions in Chinese translation.

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.

Formatting Annotated Case Report Forms (aCRFs): Part 3

October 9, 2020

Versions and Revisions

You need to annotate and submit only the unique forms from the final version of the CRF, provided that they cover all the collected data. Combine all unique pages, e.g., those for clinical data and central review data, into a single acrf.pdf. Here are some example scenarios:

  • If Version 1 had pages not used to collect data, and Version 2 removed those pages, then submit only Version 2.
  • If Version 1 had pages used to collect data, but Version 2 removed those pages, then submit both versions.