FDA submission requirements to use CDISC’s SEND data standard is going to be applicable for studies starting end of this year (and end of next year for certain study types). Now is a good time for CROs and the sponsors, to start looking into the data standard.
We at Nimble Clinical research use Nimort (in-house developed), a web-based reporting, data standardization and data management system to support clinical trial research. Nimort can be used to prepare CDISC based data packages for submission purposes. Fortunately, CDISC’s SDTM and SEND data standards are very similar. This allowed us to tweak our system for SEND standard. Within a week we were able to adapt our system for SEND and generate a sample SEND data submission package for testing and demonstration purposes.
We are freely sharing this test data submission package in this post. The data submission package is entirely based off dummy data prepared in-house.
The sample submission data package consists of following files: –
- 18 domains (BG, BW, CL, CO, DM, DS, EX, FW, LB, MA, MI, OM, POOLDEF, SUPPEX, TA, TE, TS, and TX) in compliant SAS XPT format
- xml and corresponding stylesheet file
- pdf (converted from define.xml).
- Reviewer’s Guide
Note that the several data compliance issues were intentionally left unresolved for testing and demonstration purposes. The results of compliance checks aren’t included in attached reviewer’s guide.
This sample SEND based submission data package can be requested at email@example.com. It can be used for reference and testing. Please feel free to contact us with any questions you may have.