Study Data Standardisation Plan (SDSP) Package
- Former user (Deleted)
- Alex Pearce
- Former user (Deleted)
Owned by Former user (Deleted)
| Overview | Version/Publication Date | Link |
|---|---|---|
| The SDSP documents the data standardisation approach for clinical and nonclinical studies within a development program. This Package includes information on the CBER appendix, with proposed domain/variable usage. The SDSP Package includes the template, completion guidelines, sponsor implementation guide, and examples. | Version 1.0, 16-Jan-2018 |