Controlled Terminology Best Practices

March 3, 2021

Controlled Terminology have you confused? We got you.

When starting a new clinical study and preparing the data collection design, you may ask yourself: How important is Controlled Terminology (CT)? How do I prepare the data collection process to be CDISC compliant and avoid rework for submissions? We often receive questions such as these. Whether you are newer to clinical studies or a seasoned veteran, CT can often be an elusive and confusing topic. Having a better understanding of CT standards and requirements, as well as CT-related issues found in validation checks, can improve your submission data and processes.

CDISC ADaM Validation with P21

December 1, 2020

P21 Validation Engine Improvements

The P21 Validation Engines are consistently updated and improved upon with insights from our Subject Matter Experts, consultations with regulatory agencies, and findings submitted by our users. Examples include:

  • AD1012 has been split into two rules: AD1012 and AD1012A. The former checks for custom variables and is a Warning; the later checks for standard variables and is an Error. These rules consider secondary variable names ending in *N or *C, for numeric or character equivalent, respectively.

  • AD0047 was producing problems for some variables but has already been fixed and patched for over a year.

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.

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.

Best Practices for Annotated CRFs

August 4, 2020

The SDTM annotated CRF (aCRF) is a cumbersome submission document to create. It's also highly important. It visually documents how data are mapped from the CRF to SDTM. Because this is mostly a manual task, it is key to know what makes a high-quality aCRF.

In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices for CRF annotations. These practices ensure your aCRF meets current regulatory requirements and the needs of internal users.

How We Improved the SEND Validation Rules

June 11, 2020

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.