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.

SUPPQUAL datasets represent the non-standard variables in SDTM tabulation data. However, there is a lack of implementation metrics across the industry to understand the actual usage of SUPPQUAL datasets. In this webinar, Sergiy Sirichenko summarizes metrics from many studies and sponsors to produce an overall picture.

Our recent webinar  Confusing Validation Rules Explained generated lots of follow-up questions from you. We are addressing those questions in a series of posts. In this edition, we will clarify the meaning and purpose of the duplicate records validation rules, then answer some frequently asked questions about duplicate records.

Our recent webinar Confusing Validation Rules Explained sparked lots of follow-up questions from you. We are addressing those questions in a series of posts. In this edition, we will clarify the best practices when mapping data for screen failure, not assigned, and not treated subjects. We will also help by describing the most effective ways to respond to these situations.

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.

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.

On Friday, September 27th, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 2.0 introduce additional standard conformance rules from CDISC, support for analysis result metadata (ARM), and many other changes. At Pinnacle 21, we've got you covered. We have released support for these new rules in our latest validation engine.

Define.xml is "arguably the most important part of the electronic dataset submission for regulatory review," according to The FDA’s Technical Conformance Guide. It helps reviewers gain familiarity with study data, its origins and derivations, as well as sponsor-specific implementation of CDISC standards. In addition to the define.xml, the Technical Conformance Guide also asks that sponsors submit a stylesheet. A stylesheet transforms the define.xml into a human readable structure.