Understanding the Importance of Data Consistency and Quality in SEND Submissions
With the recent release of the FDA’s binding guidance for electronic submission of nonclinical data, sponsor submissions will be required to include electronic datasets in SEND format in addition to the study report. With this new mandate, sponsors will have to ensure consistency and quality between the electronic datasets and the study reports. Any data discrepancies between the SEND datasets and the study report will impact not just the workflow for sponsors and CROs, but also for the FDA reviewers.
Impact on FDA Regulatory Reviewers
The main goal of providing study data in SEND format is to make the regulatory review process more efficient. When provided with SEND datasets, the reviewers will have access to subject level data in NIMS, the FDA’s review system. Within NIMS the reviewers can use a number of analytical views to assess trends and potential areas of toxicity within a study. Reviewers will use the study report to confirm and compare any patterns or observations found in NIMS.
Any discrepancies found may result in data curation or data consistency checks through the Nonclinical JumpStart service. Data curation or consistency checks can result in delay of the study review and, in extreme cases, may result in the study being returned to the sponsor.
Impact on Sponsors
The current process for generating SEND datasets for sponsors is shown below. Data from LIMS extracts are carefully curated prior to being added to the study report. Similar processes will be applied when creating SEND datasets; however, without proper mechanisms in place this process can easily lead to discrepancies between the SEND datasets and study reports.
After having invested significant amounts of time and money to both develop the product and prepare the submission, the possibility of a delay for data inconsistency is a risk well worth avoiding.