Pinnacle 21 is presenting on several topics at PhUSE Connect in Orlando March 9th - 11th! Come check us out!
Best Practices for Annotated CRFs (Paper SI-01)
Amy Garrett, Monday, March 9th 4:00pm
There is no doubt that the SDTM annotated CRF (aCRF) is one of the most cumbersome submission documents to create. Once a purely manual task, the extreme burden of creating the aCRF has led to several novel methods to automate or partially automate the process. As the industry moves away from manually annotating CRFs and towards automation, it’s more important than ever to truly understand the properties of a high-quality aCRF. This paper reviews published guidance from regulatory agencies and provides best practices for CRF annotations. Following these best practices will ensure your aCRF fulfills current regulatory requirements and meets the needs of internal users and programs.
Getting It Right: Refinement of SEND Validation Rules (Paper SA-05)
Kristin Kelly, Tuesday, March 10th 2:00pm
The CDISC SDTM metadata, outlined in the SDTM Model, are used for submission of data from both clinical trials and nonclinical studies. Until recently, many of the Pinnacle 21 validation rules were assigned for both SDTM and SEND domains when in some cases, a specific rule did not apply for SEND data as outlined in the SENDIG. Over the past year, the SEND rule set has been refined through the modification of existing rules, removal of others and creation of new rules. All rules are based on either an FDA Business rule, an FDA Validator rule, or CDISC rules. This paper will discuss some of the changes that have been made in an effort to ‘get the rules right’ for SEND.
Authoring ADaM Specs within P21 Enterprise (Demo SD-06)
Trevor Mankus, Tuesday, March 10th 2:30pm
If we were to survey industry and ask what tool each company uses to author specifications for clinical data, the overwhelming majority would likely say Microsoft Excel. Excel can be incredibly versatile and can serve many purposes; however, it was never designed to serve as a solution to writing mapping specifications for SDTM and ADaM data across our industry. Industry has made Excel work for the purposes of authoring specifications, but there are many gaps that are still unable to be filled based on limitations within Excel itself. Come watch a demo of a new module coming to P21 Enterprise; ADaM Designer.
Confusing Data Validation Rules Explained, Part 2 (Paper SI-14)
Michael Beers, Tuesday, March 10th 5:30pm
The 2018 PhUSE US Connect paper ‘Confusing Data Validation Rules Explained’ by Pinnacle 21 discussed some of the more confusing data validation rules, including the possible sources of confusion, and clarifications on the intent and purpose of the validation rule. This paper will discuss a new set of confusing validation rules, and explain what the resulting validation issues would mean.
SUPPQUAL datasets: good bad and ugly (Paper DS-09)
Sergiy Sirichenko, Wednesday, March 11th 9:30am
SUPPQUAL datasets were designed to represent non-standard variables in SDTM tabulation data. There are many recent discussions about whether the SDTM Model should allow the addition of non-standard variables directly to General Observation Class domains instead of using SUPPQUAL datasets. However, there is still a lack of implementation metrics across the industry to understand actual utilization of SUPPQUAL datasets. In this presentation we will summarize metrics from many studies and different sponsors to produce an overall picture of utilization of SUPPQUAL datasets by the industry. We will analyze commonly used SUPPQUAL information for being potentially promoted to standard SDTM variables. Also, we will provide and discuss examples of correct and incorrect utilization of SUPPQUAL datasets in submission data to understand if the industry is ready to switch from SUPPQUAL datasets to non-standard variables.