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The Pharmacist's Role in Aspire - Durban

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<strong>The</strong> Pharmacist’s <strong>Role</strong> <strong>in</strong> <strong>Aspire</strong>Presented by Jeeva MoodleyPharmacist – Isip<strong>in</strong>go CRSHIV Prevention Research UnitSouth AfricanMedical Research CouncilMTN Regional meet<strong>in</strong>gCape TownOctober 2012


CTU Pharmacy DepartmentCRS LeadersCTU PIPharmacy Manager:Jothi MoodleyBack up PharmacistsX 3: Aruna Ratanjee,Faeeza Arbee andMelissa GovenderPharmacist AssistantsX 2: Vanitha Saklooand Nishi Nurshaye<strong>The</strong>se staff are rotatedto the sites on a dailybasis.Botha’s Hill Chatsworth Isip<strong>in</strong>go Verulam Tongaat UmkomaasPoR: NivritiHurbansPoR:ShellendraDevnara<strong>in</strong>PoR: JeevaMoodleyPoR: AlishaNarasPoR: LeanneVallabhjeePoR: LevanyaParamanund


Pharmacist’s Primary <strong>Role</strong>Randomizationto StudyProductDispens<strong>in</strong>g atEnrolment andFollow UpStorage andControl –ma<strong>in</strong>ta<strong>in</strong>bl<strong>in</strong>d<strong>in</strong>gCollection andDestruction ofUnused R<strong>in</strong>gsOrder<strong>in</strong>gandReceiptStudy ProductManagementandAccountabilityInternal QC


Pharmacist’s <strong>Role</strong> <strong>in</strong> <strong>Aspire</strong>DestructionbucketsCondomprovisionEmergencydrugsCalibration andMa<strong>in</strong>tenanceof EquipmentNID’s –STI andContraceptionprovisionPharmacyTemperaturemonitor<strong>in</strong>g


Additional : Pharmacist’s role <strong>in</strong> Cl<strong>in</strong>ic1. QC of Cl<strong>in</strong>ic Study product accountability processes• QC of R<strong>in</strong>g Accountability Records• QC of R<strong>in</strong>g Accountability Cover page• QC of R<strong>in</strong>g Collection/Insertion (RCI-1)CRF2. QC of Ppt Registration Log (to prevent Co-enrolment)3. QC of Screen<strong>in</strong>g Files4. Review of IC’s(3 and 4 above ,done daily or weekly depend<strong>in</strong>g on cl<strong>in</strong>ic requirements. Documented on aPharmacy QC log. Tra<strong>in</strong><strong>in</strong>g on cl<strong>in</strong>ic file review will be provided by site management)


Conclud<strong>in</strong>g Remarks• Pharmacists as part of the research team, play an important role <strong>in</strong> <strong>Aspire</strong>• Requires attention to detail and effective QA/QC to ensure high quality ofwork• Utilise expertise and skills to assist Cl<strong>in</strong>ic to achieve overall quality data• Experience and learn<strong>in</strong>gs from VOICE• Clear communication and standardisation across sites – achieve ourgoalsThank you !

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