SEND ASSURE – Assuring your SEND Datasets are Consistent with your Study Report
The major challenge to both industry and FDA continues to be ensuring consistency between the SEND dataset and study report. This is because SEND datasets typically require multi-site coordination of CROs, LIMS systems and in-house labs. The task of accurately merging the source files is more challenging than the industry expected. Due to the discrepancies we’ve seen in datasets we created the SEND-ASSURE service to ensure your final SEND submission is fit-for-review.
What do you receive from SEND ASSURE?
- SEND-Assure report detailing:
– A summary of the discrepancies found between the SEND datasets and study report.
– A summary of the discrepancies identified in the SEND datasets against the version of the SEND IG and SEND CT used to standardize the data
– A summary of the errors and warnings identified during validation of the SEND datasets with the Pinnacle 21 and NIMS validators.
– Suggestions to mediate any validation and SEND conformance issues identified by the PCLS data services team
- NIMS Validator Report: the results of validation of the dataset against the NIMS validator
- Pinnacle 21 Validator Report: An Excel file that contains the results of validation of the dataset
against the Pinnacle 21 validator
- Pinnacle 21 Validation, set to DEFINE standard, of the Define.xml file
- Modifications/suggestions for the SDRG