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United Lincolnshire Hospitals NHS Trust

Lincolnshire Clinical Research Facility

Process for Obtaining Pharmacy Green Light for a Clinical Trial Involving an Investigational Medicinal Product

Pharmacy approval needs to be obtained before a clinical trial; which involves medication can start. Pharmacy approval is the final approval that is needed in conjunction with the R&D approval to start your study. The green light processes below explains how this process occurs.

1. Send copies of all approval documents (see checklist) to Clinical Trials Pharmacist, Pharmacy, Lincoln
2. Pharmacy checks all documents, assembles folder, obtains IMP/s and QP release papers, sets up electronic systems, generates prescriptions SOPs and worksheets for each site running trial
3. Once all processes complete, Clinical Trials Pharmacist signs green light forms for each site; one copy for trial master file, one for pharmacy trial folder
4. Investigator and research staff for trial at each site notified by pharmacy that recruitment to trial may start

Process (in flow chart form)

Pharmacy Research Team