Pharmacy Site File Documentation
On this page you will find all relevant documents and resources for setting up and conducting the trial at site.
To help you with this, please find a pharmacy version control log listing all of our documents here.
If you wish to print these documents to create a paper PSF, please find an index here. A PSF receipt can be found here.
To request previous document versions please email: stress-l@warwick.ac.uk
1. Protocol
2. Approvals
3. Trial Contact Information / Training / Correspondence
4. Guidelines
5. Randomised Participants
6. Summary of Product Characteristics (SPC)
7. Receipt and Storage Records for IMP
8. Dispensing / Inventory
9. IMP Destruction
1. Protocol
2. Approvals
3. Trial Contact Information / Training / Correspondence
Trial contacts and coordination details
Pharmacy site initiation slides
4. Guidelines
Stability data regarding temperature excursions
Temp deviations due to not stopping logger
5. Randomised Participants
6. Summary of Product Characteristics (SPC)
Summary of product characteristics
7. Receipt and Storage Records for IMP
Manufacturing Import Authorisation
Note to file - Marketing authorisations