1. Investigational Drugs DUMC STERILE PREPARATIONS CLEANROOM TRAINING MODULE: 1 DUMC STERILE PREPARATIONS CLEANROOM

2. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS PHARMACIST DUTIES: Identify protocol (IDS or ONC) by drug name and IRB number. Retrieve protocol notebook located in the supply cabinet in the anteroom. Read information for compounding (SPA Procedures in IDS or ONC notebook). 2 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

3. PHARMACIST DUTIES: Complete study drug accountability log. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 3 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

4. PHARMACIST DUTIES: Complete study drug accountability log. Be sure to sign out for each supply – drug, diluent, and vial size. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 4 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

5. PHARMACIST DUTIES: Complete study drug accountability log. Be sure to sign out for each supply – drug, diluent, and vial size. Obtain drug supply from the supply cabinet in the anteroom or the investigational drug section of the refrigerator. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 5 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

6. PHARMACIST DUTIES: Complete study drug accountability log. Be sure to sign out for each supply – drug, diluent, and vial size. Obtain drug supply from the supply cabinet in the anteroom or the investigational drug section of the refrigerator. Reconcile log balance matches the actual drug supply each time study drug is signed out. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 6 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

7. PHARMACIST DUTIES: Verify that DRUG NAME and IRB/IDS NUMBER match everywhere - Study notebook, study drug supply (bin), and dose label. Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 7 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

8. PHARMACIST DUTIES: Pharmacist writes compounding instructions from the study notebook on the work label. These instructions should include: Any necessary volume or concentration calculation Auxiliary labels Expiration date Special instructions for preparation Handling instructions Investigational Drugs: PRODUCT PROCUREMENT AND COMPOUNDING INSTRUCTIONS 8 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

9. TECHNICIAN DUTIES: The technician provides all necessary documentation on the work label. Investigational Drugs: DOSE PREPARATION 9 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

10. TECHNICIAN DUTIES: The technician provides all necessary documentation on the work label. Only auxiliary labels indicated in study notebook are placed on the dose label. Investigational Drugs: DOSE PREPARATION 10 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

11. TECHNICIAN DUTIES: The technician provides all necessary documentation on the work label. Only auxiliary labels indicated in study notebook are placed on the dose label. Prepare the dose per established guidelines and according to the instructions specific to the study involved. Investigational Drugs: DOSE PREPARATION 11 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

12. TECHNICIAN DUTIES: The technician provides all necessary documentation on the work label. Only auxiliary labels indicated in study notebook are placed on the dose label. Prepare the dose per established guidelines and according to the instructions specific to the study involved. Refer to the instructions given by the pharmacist. Investigational Drugs: DOSE PREPARATION 12 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

13. The pharmacist verifies the identity and amounts of the ingredients in the dose before the product is dispensed. Refer to the PHARMACIST VERIFICATION OF CSPs SOP for more information on end-product verification. Investigational Drugs: VERIFICATION AND RELEASE OF THE DOSE 13 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009

14. End of Presentation: Take the Test! 14 DUMC STERILE PREPARATIONS CLEANROOM JG/SA 2009