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The Global Health Network

The Global Health Network. Sourcing, Preparing and Accounting for Investigational Products. Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014. IMP/IP. IMP (Investigational Medicinal Product) / IP (Investigational Product ) Sourcing and Receipt Storage Dispensing/Blinding

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The Global Health Network

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  1. The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014

  2. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  3. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  4. Sourcing and Receipt • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  5. Receipt Accountability Sourcing and Receipt • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

  6. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  7. Storage • Certificate of Analysis (COA) •  light, temperature, humidity • Rigorous Control •  E.g. fridges, air-con, probes, light protection • Unique Storage Space • Back-Up Plan Sources of Accountability: Temperature Logs, Calibration Certificates, SOPs, COAs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  8. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  9. Dispensing • Dispensing Licence • Expiry Dates • IP prep (e.g. reconstitution, infusion) • Labelling requirements •  e.g. Participant ID, Study/Protocol/Investigator ID, Quantity Dispensed, Mode of Delivery, Storage Condition, Exp./Lot/Batch #’s • Blinding – implication for dispensing directly to patient • Unblinding procedure Source of accountability: MCC documentation, Pharmacy Manual (accountability, labels, patient dispensing logs) UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  10. Store Accountability Sourcing and Receipt • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

  11. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  12. Randomisation • Treatment Allocation/Dispensing • Generated by statistician/pharmacist (sponsor or site produced), stored in secure location e.g. pharmacy file •  Randomisation schedule or Automated system e.g. IVRS • Randomisation log Source of accountability: Randomisation schedule and Randomisation logs UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  13. Randomisation Schedule Accountability Sourcing and Receipt • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

  14. Randomisation Log Accountability Sourcing and Receipt Randomization Log for: PLACEBO FOR IMP Randomization Log for: ACTIVE IMP • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

  15. IMP/IP IMP (Investigational Medicinal Product) / IP (Investigational Product) Sourcing and Receipt Storage Dispensing/Blinding Randomisation Disposal/Destruction UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  16. Return/disposal • At conclusion of study, final inventory and reconciliation • Sponsor-driven: return to sponsor for disposal or site arranges disposal • Arrange with waste disposal company Source of accountability: Disposal/Destruction Log UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  17. Destruction Log Accountability Sourcing and Receipt • Sponsor-driven Phase I: • New IMP & Formulation • Sponsor arranges manufacture • Importing • Dummy Dispensing • Investigator-led Phase III: • Typically Locally-Marketed Product • Pharmacist sources IMP • Dummy Dispensing Source of Accountability: Delivery waybills, Prescriptions, Invoices, Receipt Accountability

  18. SUMMARY • Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time • Accountability is a continuous process from start of study until closure • Inform/involve pharmacy at the outset • Resources available on CRC website - http://www.crc.uct.ac.za/ UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

  19. SUMMARY • Importance of pharmacy role: maintains accountability of IMP from start to finish, ensuring right dose given to right patient at the right time • Accountability is a continuous process from start of study until closure • Inform/involve pharmacy at the outset • Resources available on CRC website - http://www.crc.uct.ac.za/

  20. Questions? | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

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