Create a template form to document approval for shipment of investigational supplies for a Phase 3 drug study conducted in the US. Make sure to include verification of essential documents required for
Create a template form to document approval for shipment of investigational supplies for a Phase 3 drug study conducted in the US. Make sure to include verification of essential documents required for shipment of investigational supplies. This can include documents required by FDA regulation, ICH and/or SOPs.
Background information: In the management of clinical studies, clinical research is responsible for requesting drug/device from another department that ships investigational supplies. A clinical research professional completes a form/checklist to document or authorize that all required regulatory and study documentation is available for a clinical site and the site is ready to receive clinical supplies. This form will require documentation of approval by key team members.