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

4. 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

5. 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

6. 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
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

7. Sourcing and Receipt Sponsor-driven Phase I:
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
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability

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. 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

10. IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product)
Sourcing and Receipt
Storage
Dispensing/Blinding
Randomisation
Disposal/Destruction
These are components of accountability.
Highlight differences btwn sponsor driven vs investigator led studies
Investigator led: sourcing, accountability forms, manuals – derived from investigator and site.
Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site.
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

11. 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
Dispensing licence required: hospital nurses have dispensing licence however relevant to their scope of practice within hospital, not clinical trials.
GMP: anything more than reconstitution – refer to MCC webpage
Blinding: double blinds vs single vs open label. Safe dispensing of blinding. Unblinding SOP – how to unblind when required. Example of closed envelopes per patient provided or can create yourself. As long as securely stored
If intervention is vaccine/infusion and/or blinded study, implication for dispensing? Grey area re direct dispensing by pharmacist
MCC documentation: SAPC registration, declaration, CV, Insurance (?)
Source of accountability:
MCC documentation, Pharmacy Manual (accountability, labels, patient dispensing logs)
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

12. Sourcing and Receipt Sponsor-driven Phase I:
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
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability

13. IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product)
Sourcing and Receipt
Storage
Dispensing/Blinding
Randomisation
Disposal/Destruction
These are components of accountability.
Highlight differences btwn sponsor driven vs investigator led studies
Investigator led: sourcing, accountability forms, manuals – derived from investigator and site.
Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site.
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

14. 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

15. Sourcing and Receipt Sponsor-driven Phase I:
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
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability

16. Sourcing and Receipt Sponsor-driven Phase I:
Randomisation Log Accountability
Sourcing and Receipt
Randomization Log for: ACTIVE IMP
Randomization Log for: PLACEBO FOR 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
Focus on type of study e.g. blinded? – to assist with securing appropriate placebo to ensure blinding e.g. same smell, look, feel
Focus on type of study e.g. blinded?
Sponsor vs investigator-led
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability

17. IMP/IP IMP (Investigational Medicinal Product) /
IP (Investigational Product)
Sourcing and Receipt
Storage
Dispensing/Blinding
Randomisation
Disposal/Destruction
These are components of accountability.
Highlight differences btwn sponsor driven vs investigator led studies
Investigator led: sourcing, accountability forms, manuals – derived from investigator and site.
Sponsor: often provide documentation, IP in formulation, handling procedures, accountability forms and SOPs. Less required by site.
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

18. 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

19. Sourcing and Receipt Sponsor-driven Phase I:
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
Source of Accountability:
Delivery waybills, Prescriptions, Invoices, Receipt Accountability

20. 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
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014

21. 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

23. | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
4/15/2017
Questions?
| IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
| UCT Clinical Research Centre | Pharmacy Core Group | 08 July 2014 | 1st Forum Meeting