Would it be impossible to expect such help in the real world?
A clinical SAS programmer can notify the data management team during study-live, thereby helping to re-investigate data issues.
Programmers get a consolidated list of critical errors in the SDTM package, so chances of sponsor finding are reduced.
When issues in SDTM are identified, programmers are supported in such a way that enables traceability of the data collected.
So what can be achieved?
Contribute to a better assessment of the quality of clinical data
To comply with CDISC/ FDA guidelines
To perform the checks which are yet to be integrated to Pinnacle 21 Validator
Has a strong understanding of SDTM and data compliance.
Not a wallflower- but also user friendly
Expertise in various skills: [Structure Compliance, Cross-domain verification, cross variables verification, data/terminology]
Can distinguish between the programming error/data issue and the criticality of the issue.
Can draw a distinction between pinnacle vs non-pinnacle checks, which are mainly CDISC/SDTM IG 3.2 compliance checks.
Can be integrated with all kinds of SAS environments and set-ups.
Can highlight the issues in a detailed manner like the SDTM domain, its variable, and the value within it where the issue occurred.
Can help in the traceability of data collected from EDC, to ensure data integrity.
Can be a great input for documenting the issues that needs to be addressed in Reviewer’s guide.
Can capture more issues with Low detection limit.
How it works?
Once the SDTM dataset is clinically evaluated by the CDISC Checks, Open CDISC Validator/Pinnacle 21 won’t surprise the SAS programmer about the quality of SDTM domains.