STAKT Investigator Meeting

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

7. 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

8. 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

9. 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

10. 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