In this webinar, we discussed how SEND-ASSURE ensures consistency with the audited Study Report, conformance to Technical Rejection Criteria guidelines, and follows details of the Technical Conformance Guide as the trusted references for data submission and regulatory compliance.
Key Takeaways:
- The most common errors in SEND with recommendations to correct them
- Feedback related to submission and analysis
- Pinpoint QC ideas
Submit with Confidence: We covered the common issues to look out for in your SEND datasets. PointCross has standardized and quality checked over 7,500 SEND datasets over 10 years. Our experts shared insights on common validation tool triggered rules that affect SEND dataset preparation by Sponsors, CROs, and 3rd Party Vendors.
Webinar Recording
Watch the recording of the webinar below:
Questions asked during webinar:
- What do you use to create your define files?
Internally, Xbiom technology is used for SEND generation. Our eDataValidator online application can be used to create define.xml files for already prepared SEND datasets.
- As we know, SEND datasets reflect the report. However, from time to time, we see different presentations in In-Life information (mostly wording of the report) and the individual appendix. For example, is there any standard for Planned Time Point Name to help you choose the correct one?
The SEND Implementation Guide has provided multiple examples as to how planned time points can be represented, as each CRO, Sponsor, and Test Site can record their own planned time points. A standardized format most closely relating to the study report is used by PointCross. If multiple representations are used, the most common or most consistent timepoint is typically used; PointCross will also refer to other studies in the same compound to maintain consistency for future cross-study analysis.
Additionally, the representation in –TPTNUM should also be in order– 30 minutes should only be represented as “30” when all timepoints are represented as minutes; when timepoints are a mix of minutes, hours, and potentially days, –TPTNUM should be sequential in order of the time since the reference timepoint (immediately post dose, 30 minutes, 1 hour, 1 day).
- Could you clarify your statement regarding including “Out of scope” data and providing an example of ADA as per the new SEND i.g 3.1.1 in your presentation?
Data is considered “out of scope” for SEND when the test subject is not modeled into SEND – i.e. functional observational battery assessments are considered “out of scope”, but could be represented in a tabular model, and could be included per the language in the TCG and since SENDIG 3.1.
Some SEND preparers include language in their nSDRGs that because an assessment is out of scope, it should not be included in the SEND dataset. Examples of “out of scope” assessments include ADA data, Nervous System Test Results, Ophthalmic examinations, and Cell phenotyping; PointCross takes the view that in order for the SEND dataset to be rendered effective for analysis, all study endpoints should be included in their appropriate custom domains at no additional charge with a 100% successful submission rate. PointCross populates these domains based off of recommendations in the PHUSE whitepapers, SDTM model, and any other guidance that may be released in the meantime.
- How long does the SEND QC process take? Will you fix a SEND dataset?
The SEND-Assure deliverable is ready in approximately 2-4 weeks. PointCross does offer SEND-Assure + QC Correction services; please contact us at ask@pointcross.com for a quote or use our online quote generator.
- What set of validation rules are used?
Validation rules for the eDataValidator are updated with various rules and guidance updates. Please see eDataValidator: (https://pointcrosslifesciences.com/edatavalidator/).
- What is the difference between a conformance rule and a traceability error?
An error in conformance is one that violates a rule as put out by a standards organization (i.e. CDISC Conformance Rules), FDA Technical Rejection Criteria, FDA Business Rules, or FDA Validator Rules.
An error in traceability is one in which there is a discrepancy between some combination of the study report, raw study data, and the SEND dataset.
- How do I view my SEND package?
PointCross uses the Xbiom-Insights tool to both visualize the .xpt files, as well as the data that is ingested to create the SEND dataset.
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