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STAKT Investigator Meeting

Research & Development Pharmacy Services. STAKT Investigator Meeting. Management of IMP in Pharmacy Peter Fox. Pharmacy IMP Management. Prescriptions Accountability Logs Dispensing Records Temperature Monitoring Emergency Unblinding. Pharmacy Documents.

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STAKT Investigator Meeting

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  1. Research & DevelopmentPharmacy Services STAKT Investigator Meeting Management of IMP in Pharmacy Peter Fox

  2. Pharmacy IMP Management • Prescriptions • Accountability Logs • Dispensing Records • Temperature Monitoring • Emergency Unblinding

  3. Pharmacy Documents • Separate Documents for Stage 1 and Stage 2 • Documents available for each stage: • Prescription • Drug Accountability Log • Dispensing Record

  4. Prescription Stage 1

  5. Temperature Monitoring • IMP must be stored below 30oC • Pharmacies will be expected to monitor storage temperatures • A record form will be designed for use if the Pharmacy does not have an in-house policy • A procedure for dealing with temperature excursions will be written

  6. Emergency Unblinding • An Emergency Unblinding Service will be provided by the Pharmacy, Royal Derby Hospital • Available 24 hours a day, 7 days a week • Provided by Pharmacy Clinical Trial Team during Office hours and On-call service outside these hours • In the unlikely event of the RDH service being unavailable Cenduit will be able to unblind in emergency situations

  7. Emergency Unblinding • It is expected that the request for unblinding will come from the study team, however unblinding requests would be accepted from others in emergency situations • The RDH staff will not be able to judge the appropriateness of the request and will always provide the information

  8. Emergency Unblinding • The RDH staff will take details of the patient, reason for request, name and contact details of the requester • They will get the patients treatment allocation from the IWRS system and then phone back. The phone call will be followed by a confirmatory fax

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