4 DSUR, Biostatistics, Sponsor Oversight, and More Updates
ClearTrial 6.0 adjusts existing 5.9 resources and resource level-of-effort algorithms for existing Drug Safety Update Reporting, Biostatistics, and Sponsor Oversight tasks in the 6.0 Cost Model.
| 5.9/6.0 Major Task Name | 5.9/6.0 Task Name |
|---|---|
| Annual Drug Safety Update Report | Conduct summary of the status of each study in progress or completed during the previous year |
| Annual Drug Safety Update Report | Conduct summary of the status of the subjects planned and the number entered into the study |
| Annual Drug Safety Update Report | Prepare summary of any study results available |
| Annual Drug Safety Update Report | Prepare summary of serious adverse events (SAEs) |
| Annual Drug Safety Update Report | Prepare summary of deaths |
| Annual Drug Safety Update Report | Prepare summary of discontinued subjects |
| Sponsor Oversight | Oversee - Annual IND Report Activities |
| Issued Unique Summary Table | Complete unique summary table programming |
| Issued Unique Summary Listing | Complete unique summary figure/graph programming |
| Issued Repeat Summary Figure/Graph | Complete repeat summary figure/graph programming |
| Sponsor Oversight | Oversee – Issued Summary Table |
| Sponsor Oversight | Oversee – Issued Listing |
| Sponsor Oversight | Oversee – Issued Figure/Graph |
| Interim Analysis | Provide/review/approve interim analysis |
| Interim Analysis | Provide/review/approve interim SAS dataset design |
| Interim Analysis | Provide/review/approve interim tables |
| Sponsor Oversight | Oversee - A Written Protocol |