Data standardization is critical to ensure successful regulatory submissions. While many sponsors now choose to create CDISC compliant outputs as part of their in-line study analysis and reporting, inevitably legacy conversion of older studies is required.
A legacy conversion project is one which requires a significant transformation effort, where neither CDASH nor SDTM has been used. Migrating to SDTM is of course a complex activity, requiring a precise and intelligent approach- it’s not just a matter of renaming variables. A gap analysis which assesses the current state of the data can ensure the project is commenced on the right footing. In the below example, we conducted a gap analysis as part of a project for a client who engaged Cytel for support with their ISS/ISE.
Gap Analysis Sets the Right foundations
Our client was a small biotechnology company with limited operational staff- they approached Cytel to help them with an ISS/ ISE.
They had been working with a full service outsourcing model which had resulted in their studies being handled by multiple CROs. CDISC standards had been only partially implemented for the historic studies and there was a lack of understanding as to what would be required. In this tricky situation, with an ISS/ISE forthcoming, the client asked Cytel to oversee the activity of the CROs working on the ongoing studies and prepare the ISS/ISE.
In this context, it was critical to conduct a gap analysis to properly identify the difference in data collection formats and clarify the scope and challenges of the migration activities before commencing the project. Key tasks we conducted as part of the gap analysis included:
Itemizing and evaluate files to support migration activities
Creating a Document inventory (taking into account Study documents, CDISC standards, Company standards and Company Implementation Guidance
Validating sample CRF fields versus source data
Verifying external data requirements e.g. central labs or local labs
Comparing protocol amendments/versions against CRF versions
In this initial stage we assessed the status of the data which had already, or partially been migrated into SDTM and quantified any gaps. It was an opportunity to do first ‘pruning’ of the raw datasets and compare the aCRF against the raw datasets. As part of this stage it is also important to look at the status of medical coding for conmeds and AEs. It may be required to bring the coding up to date with the latest version of MedDRA.
By conducting a full assessment of the data, we were able to properly lay out the process for the project moving forward. At Cytel, 100% of our statistical programming team are experienced in SDTM and ADaM, and many of our experts are recognized experts in CDISC, participating in key industry events. Cytel experts are part of the CDISC European Committee, and will be participating in the next CDISC European Interchange on 25th -29th April in Vienna. Cytel is a CDISC Registered Solutions Provider.
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This blog is based on content provided by Angelo Tinazzi. Many thanks Angelo!