CT-Study file in the recruitment an delivery phase

While the study is ongoing the study files have to be maintained. See CT SOP Study Files for information and see checklists Checklist Conduct of Clinical Trial – Sponsor and Checklist Conduct of Clinical Trial – Center

All unused study drug must either be returned to sponsor or destroyed. The templates below should be used if a specific stock with study drug has been provided for the study.

IMP Reconciliation

IMP Destruction