1. Maintenance, Management and Monitoring of Investigational Supply
Kim McConnell, PharmD, CCRP
CCOP Annual Investigators Meeting
Houston, Texas
March 3, 2011

2. Objectives
To present and review regulations that apply to the maintenance, management and monitoring of Investigational doses
To review milestones for an Investigational Protocol as they relate to Investigational doses
To provide pointers for practical application of this information for the management and maintenance of Investigational inventory

3. Regulations Pertaining to Investigational Doses and Supply

4. Roles and Responsibilities of the Investigator
Properly administer doses to enrolled Patients
21 CFR , ICH GCP 4.6.5
Maintain complete documented accountability of inventory
21 CFR , ICH GCP 4.6.3
Maintain proper storage conditions
ICH GCP 4.6.4
Return/Destroy all unused inventory as instructed
21 CFR
Delegation of duties where applicable
ICH GCP 4.6.2
Document retention*
21 CFR , ICH GCP 4.9.5

5. Roles and Responsibilities of the Sponsor
Document retention*
21 CFR , ICH GCP
Provide information on Investigational Product
21 CFR , 21 CFR312.50, ICH GCP 5.12
Proper delivery, packaging and labeling of Investigational Product
21 CFR , 21 CFR , 21 CFR 312.6, ICH GCP 5.13, 5.14
Proper instruction for use and maintenance of Investigational Product
21 CFR , 21 CFR , ICH GCP 5.14
Verification of proper usage of Product
21 CFR , ICH GCP 5.18
Provide safety information regarding product
21 CFR , 21 CFR , 21 CFR , 21 CFR312.56

6. Additional Regulations and Guidelines
Additional Federal Guidelines
State Law
Institutional Policy and Procedures
Departmental Policy and Procedures

7. Protocol Milestones

8. Protocol Milestones Site Activation Inventory Request and Receipt
Maintenance of Supply
Storage
Dispensing
Maintaining the Blind
Expiration/Recall
Study Monitoring
Study Closeout

9. Site Activation Supporting Documentation Requested IRB Approval Letter
Policies and Procedures
Destruction Policy
Accountability Records
Contact Information
Unblinded Team Members

10. Requesting Inventory Determining Initial Supply Needs
Number of Patients
Dosing Schedule
Blinding and Supply Presentation
Study Specific Order Form
Site Contact Information
Protocol Number
Protocol Title
Quantity Needed
Date Needed
Turnaround Time

11. Inventory Receipt Documentation of Receipt Shipment Acknowledgement
Packing Slip
Accountability Record
Shipment Acknowledgement
Recordkeeping

12. Maintenance of Supply Storage Conditions and Monitoring Security
Room Temperature
Refrigerated
Security
Secure area with limited access
Documentation

13. Dispensing Medication
Methods for Preparation
Proper Labeling
Required components of labeling
Blinded Presentation
Verification of Doses and Dispensing Accuracy
Confirmation of Kit Number/Treatment
Recording of Information
Record Retention

14. Dispensing Medication: Mailing Supply
Requirements for Mail Out
IND Status
Permission to Mail Out
Record Retention
Requirements and Guidelines
Federal Regulations 21 CFR , 21 CFR
State Regulation
Institutional Policies

15. Maintaining the Blind Randomization Record
Familiarity with Study Design and Schedule
Identification of Blinded and Unblinded Personnel
Access to Treatment Assignment
Steps for Randomization
Steps for Verifying Randomization

16. Expiration or Recall of Stock
Notification
Final Accountability
Final Disposition
Destruction vs Return to Supplier
Documentation

17. Study Monitoring
Record Requests
Count Review
Discrepancies

18. Study Closeout
Complete Accountability
Final Disposition
Documentation

19. Practical Application

20. Ideas for Practical Application
REMEMBER THE PATIENT
Organization of Records
Knowing the Inventory
Knowing the Protocol
Randomization and Maintaining the Blind
Maintaining Contact
Asking Questions
Documentation

21. REMEMBER THE PATIENT

22. Organization of Records

23. Organization of Records
Maintain a consistent filing system
Include a copy of the treatment plan
Include instructions for coverage
Find a system that works

24. Knowing the Inventory

25. Knowing the Inventory How is it supplied? How must it be taken?
Appearance and Blinding
Tear off Labels and Kit Numbers

26. Knowing the Protocol

27. Knowing the Protocol
Understand and be aware of the milestones and treatment plan throughout the Protocol
Review for information as it pertains to inventory
Storage Conditions
Emergency Reassignment
Unblinding
Unused Medication

28. Randomization and Maintaining the Blind

29. Randomization and Maintaining the Blind
How does randomization work?
Access and Procedures for Computerized Randomization
How will this inventory be presented to the Patient?
What is everyone’s blinding status on the Study Team?

30. Keep In Contact

31. Communication and Asking Questions

32. Summary REMEMBER THE PATIENT
Know and understand the responsibilities of the Sponsor and Site Investigator
Stay within the definition of local, state and Federal requirements
Be aware of your resources
Maintain perpetual, timely and accurate documentation
Be familiar with the Protocol and the Product
Maintain blinding
If in doubt, ask

33. kmcconnell@mdanderson.org invdrugs@mdanderson.org