Management of IMP in Pharmacy Peter Fox STAKT Investigator Meeting Research & Development Pharmacy Services

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

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

Prescription Stage 1

Temperature Monitoring IMP must be stored below 30 o C 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

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

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

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