Subject Registration Coordinating Center Electronic Drug Accountability System Participating Site Online Agent Ordering Process (OAOP) NCI CTEP Pharmaceutical Management Branch (PBM) Drug Authorization and Review Tracking System (DARTS) 1. Sub. registered 2. Drug Order 3. Drug Order 4. Drug Order Approval 5. Drug Shipped Notification 6a. Shipment Received Notification (?) 6b. Shipping Discrepancy Notification Electronic Agent Ordering and Accountability Record for Non-Blinded Study-Level Supplies Subject Registration Sub. registered Legend: = assumptions / pre-conditions = scenario steps As in presentation

Electronic Drug Accountability System Participating Site Online Agent Ordering Process (OAOP) NCI CTEP Pharmaceutical Management Branch (PBM) Drug Authorization and Review Tracking System (DARTS) Drug Order 3. Drug Order 4a. Drug Order Approval 5a. Drug Shipped Notification 6a. Shipment Received Notification (?) 6b. Shipping Discrepancy Notification Electronic Agent Ordering and Accountability Record for Non-Blinded Study-Level Supplies Site Subject Registration System Sub. registered 5b. Order Disapproval 4b. Order Disapproval Updated – ask Rodney Should all msgs go to/from OAOP?

Participating SiteNCI CTEP Pharmaceutical Management Branch (PBM) Online Agent Ordering Process (OAOP) OR Drug Authorization and Review Tracking System (DARTS) (TBD which) 2. Query criteria 4. Matching eDARs Dispensing Study Agents for Administration to Study Subject in Non-Blinded Study 1. Transaction for dispensed agent 3. Revisions to matching eDARs Electronic Drug Accountability System

Participating Site NCI CTEP Pharmaceutical Management Branch (PBM) Online Agent Ordering Process (OAOP) OR Drug Authorization and Review Tracking System (DARTS) (TBD which) 3. Shipment received notification 2b. Agent shipped notification Study Agent Sponsor Manages Return of Un-Dispensed Study Agent Supplies 4. Search for stock recovery progress 1. Stock Recovery Message 2a. Message not received w/in 3 days 5. Matching eDARs wio stock return transaction

Electronic Drug Accountability System Participating SiteNCI CTEP Pharmaceutical Management Branch (PBM) Online Agent Ordering Process (OAOP) OR Drug Authorization and Review Tracking System (DARTS) (TBD which) 3a. Request denied 2b. Local destruction request Main Pharmacy Destroys Undispensed Study Agent Due to Inability to Meet Shipping Requirements After PMB Approval 3b. Request approved 1. Stock Recovery Message 2a. Message not received w/in 3 days 4. Destruction completed notification 5. Return Number 6. Search criteria for stock recovery in eDARs 7. Matching eDARs with stock recovery history