Research Development Pharmacy Services STAKT Investigator Meeting Management
- Slides: 11
Research & Development Pharmacy Services STAKT Investigator Meeting Management of IMP in Pharmacy Peter Fox
Pharmacy IMP Management l l l Prescriptions Accountability Logs Dispensing Records Temperature Monitoring Emergency Unblinding
Pharmacy Documents l l Separate Documents for Stage 1 and 2 Documents available for each stage: – – – Prescription Drug Accountability Log Dispensing Record Stage
Prescription Stage 1
Temperature Monitoring l l 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 l l 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 l l 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 l l 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
- Investigator meeting services
- For today's meeting
- Meeting objective
- What is meeting and types of meeting
- Types of meeting
- Sip shared investigator platform
- Did investigator assign exposures
- Deductive reasoning crime scene investigation
- Diversion investigator
- "merry maids"
- Cps special investigator
- Fda clinical investigator training course