the global health network sourcing, preparing and accounting for investigational products nicky...
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![Page 1: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/1.jpg)
The Global Health Network
Sourcing, Preparing and Accounting for Investigational Products
Nicky Kramer and Wynand Smythe
19TH SEPTEMBER 2014
![Page 2: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/2.jpg)
![Page 3: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/3.jpg)
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IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 5: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/5.jpg)
IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 6: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/6.jpg)
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
![Page 7: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/7.jpg)
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
Receipt Accountability
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IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 9: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/9.jpg)
Storage
• Certificate of Analysis (COA)
light, temperature, humidity
• Rigorous Control
E.g. fridges, air-con, probes, light protection
• Unique Storage Space
• Back-Up PlanSources of Accountability: Temperature Logs, Calibration Certificates, SOPs, COAs
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 10: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/10.jpg)
IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 11: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/11.jpg)
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
![Page 12: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/12.jpg)
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
Store Accountability
![Page 13: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/13.jpg)
IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 14: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/14.jpg)
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
![Page 15: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/15.jpg)
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
Randomisation Schedule Accountability
![Page 16: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/16.jpg)
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
Randomisation Log Accountability
Randomization Log for: ACTIVE IMP Randomization Log for: PLACEBO FOR IMP
![Page 17: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/17.jpg)
IMP/IP
IMP (Investigational Medicinal Product) /
IP (Investigational Product)
1. Sourcing and Receipt
2. Storage
3. Dispensing/Blinding
4. Randomisation
5. Disposal/Destruction
UCT CLINICAL RESEARCH CENTRE | IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
![Page 18: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/18.jpg)
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
![Page 19: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/19.jpg)
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
Destruction Log Accountability
![Page 20: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/20.jpg)
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
![Page 21: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/21.jpg)
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/
![Page 22: The Global Health Network Sourcing, Preparing and Accounting for Investigational Products Nicky Kramer and Wynand Smythe 19TH SEPTEMBER 2014](https://reader038.vdocuments.site/reader038/viewer/2022110320/56649ccd5503460f94998380/html5/thumbnails/22.jpg)
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| IMP MANAGEMENT | GHTSA WORKSHOP | 19 SEP 2014
Questions?