In a recent post, we discussed how there’s quite a bit of emphasis at the moment on ensuring SEND datasets are compliant with the SEND Standard. Obviously, the main driver here is the activation of the FDA’s technical rejection criteria, which will result in the agency automatically rejecting applications which do not meet the required criteria. We’ve also seen the CDISC’s move into automated compliance checking with the initiation of the ‘CORE’ project. In fact, the whole topic of ‘compliance’ seems to be the biggest talking point in the world of SEND right now.
It should go without saying that no matter how compliant the datasets are, they also need to be a correct representation of the study data. However, it’s clear that some organizations are putting effort into compliance but forgetting the more basic principle of making sure the data are correct. I mean, there’s no point having beautifully rendered SEND datasets, with all variables populated and formatted in accordance with the standard, if the actual values are incorrect.
For clarification, I’m referring to occasions when a result in a SEND dataset doesn’t match the value in the study report. Typical issues can be things like having result data, say bodyweights, which are being reported in SEND for dates long after the subject was terminated; or negative lab results that should never be negative. All examples of data which can be rendered in a compliant manner, but still just obviously ‘wrong’.
Some of us may struggle to believe that could really occur, but it’s surprisingly easy to see how that can happen. Some organizations will collect data, complete the study, produce the PDF tables, review them and any such errors found would be corrected in the tables directly. At some point later, the SEND datasets are produced from an export from the data collection system. At this point, any corrections in the tables are not reflected in the data collection system and therefore not in the SEND Datasets.
Other practices and process which don’t consider SEND from the outset, can result in similar issues. For this reason, I continually quote what I consider to be one of the most important, and most often overlooked statements in the FDA’s Technical Conformance Guide (Section 4.1.3.2 General Considerations) “The ideal time to implement SEND is prior to the conduct of the study as it is very important that the results presented in the accompanying study report be traceable back to the original data collected.”
So, the first issue is that without proper forethought, incorrect results can occur. The second issue then is that they may be difficult and expensive to detect.
To a large degree, automated tools can be developed to check conformance, particularly with the publication of CDISC conformance rules and FDA validation rules. However, checking that a result in a SEND dataset matches the corresponding PDF table is something that still requires a human touch.
So yes, we need to ensure conformance to the standard, but how much more important is it to ensure that results themselves are correct?
Till next time,
Marc
Sensible SEND Blog 