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 |