Single trial sites
The Sponsor Lead Pharmacist must be involved with the provision of the documentation related to IMP required for regulatory submission and any amendments relating to pharmaceutical aspects of the trial.
This includes, but is not limited to:
- simplified IMPD (sIMPD)
- patient-facing documentation
- cover letters ensuring any necessary clarifications for IMP are appropriate, etc.
Multicentre trial sites
Where the trial is to be hosted by multiple sites within the UK, there is an expectation that the Health Research Authority (HRA) Pharmacy Assurance process is undertaken.
Non-Commercial Sponsors have the option of having the Sponsor Lead Pharmacist complete this without paying HRA review costs rather than submit it at a cost for standard review. Costs relating to HRA review may be incorporated into the funding application if deemed appropriate.