kim mcconnell, pharmd, ccrp ccop annual investigators meeting houston, texas march 3, 2011
TRANSCRIPT
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Maintenance, Management and Monitoring of Investigational Supply
Kim McConnell, PharmD, CCRP
CCOP Annual Investigators Meeting
Houston, Texas
March 3, 2011
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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
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Regulations Pertaining to Investigational Doses and Supply
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Roles and Responsibilities of the Investigator
Properly administer doses to enrolled Patients 21 CFR 312.61, ICH GCP 4.6.5
Maintain complete documented accountability of inventory 21 CFR 312.62, ICH GCP 4.6.3
Maintain proper storage conditions ICH GCP 4.6.4
Return/Destroy all unused inventory as instructed 21 CFR 312.62
Delegation of duties where applicable ICH GCP 4.6.2
Document retention* 21 CFR 312.62, ICH GCP 4.9.5
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Roles and Responsibilities of the Sponsor
Document retention* 21 CFR 312.57, ICH GCP 5.5.11
Provide information on Investigational Product 21 CFR 312.23, 21 CFR312.50, ICH GCP 5.12
Proper delivery, packaging and labeling of Investigational Product 21 CFR 312.53, 21 CFR 312.56-57, 21 CFR 312.6, ICH GCP 5.13, 5.14
Proper instruction for use and maintenance of Investigational Product 21 CFR 312.50, 21 CFR 312.59, ICH GCP 5.14
Verification of proper usage of Product 21 CFR 312.50, ICH GCP 5.18
Provide safety information regarding product 21 CFR 312.23, 21 CFR 312.32, 21 CFR 312.50, 21 CFR312.56
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Additional Regulations and Guidelines
Additional Federal GuidelinesState Law Institutional Policy and ProceduresDepartmental Policy and Procedures
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Protocol Milestones
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Protocol Milestones
Site Activation Inventory Request and Receipt Maintenance of Supply
Storage Dispensing Maintaining the Blind Expiration/Recall
Study Monitoring Study Closeout
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Site Activation
Supporting Documentation Requested IRB Approval Letter Policies and Procedures▪ Destruction Policy
Accountability Records Contact Information▪ Unblinded Team Members
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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
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Inventory Receipt
Documentation of Receipt Packing Slip Accountability Record
Shipment AcknowledgementRecordkeeping
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Maintenance of Supply
Storage Conditions and Monitoring Room Temperature Refrigerated
Security Secure area with limited access
Documentation
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Dispensing Medication
Methods for PreparationProper Labeling
Required components of labelingBlinded PresentationVerification of Doses and Dispensing
Accuracy Confirmation of Kit Number/Treatment
Recording of InformationRecord Retention
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Dispensing Medication: Mailing Supply
Requirements for Mail Out IND Status Permission to Mail Out
Record RetentionRequirements and Guidelines
Federal Regulations 21 CFR 312.110, 21 CFR 312.120
State Regulation Institutional Policies
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Maintaining the Blind
Randomization Record Familiarity with Study Design and
Schedule Identification of Blinded and Unblinded
PersonnelAccess to Treatment Assignment
Steps for Randomization Steps for Verifying Randomization
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Expiration or Recall of Stock
NotificationFinal AccountabilityFinal DispositionDestruction vs Return to SupplierDocumentation
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Study Monitoring
Record RequestsCount ReviewDiscrepancies
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Study Closeout
Complete AccountabilityFinal DispositionDocumentation
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Practical Application
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Ideas for Practical Application
REMEMBER THE PATIENTOrganization of RecordsKnowing the InventoryKnowing the ProtocolRandomization and Maintaining the
BlindMaintaining ContactAsking QuestionsDocumentation
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REMEMBER THE PATIENT
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Organization of Records
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Organization of Records
Maintain a consistent filing system
Include a copy of the treatment plan
Include instructions for coverage
Find a system that works
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Knowing the Inventory
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Knowing the Inventory
How is it supplied?
How must it be taken?
Appearance and Blinding
Tear off Labels and Kit Numbers
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Knowing the Protocol
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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
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Randomization and Maintaining the Blind
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Randomization and Maintaining the Blind
How does randomization work?Access and Procedures for
Computerized RandomizationHow will this inventory be presented
to the Patient?What is everyone’s blinding status
on the Study Team?
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Keep In Contact
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Communication and Asking Questions
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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 If in doubt, ask If in doubt, ask
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[email protected]@mdanderson.org