Write your trial protocol according to the SPIRIT and TIDIER guidelines https://www.equator-network.org/

Your study sponsor may have a specific protocol template you must use. If not, and if you have a KCTU co-applicant on your grant, they will be able to provide you with a template document.

You will need to apply for ethics approval for all clinical trials. This is usually via NHS ethics https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/hra-approval/

You may need other approvals, depending on your study type and setting (eg prisons) https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/prison-research/

For clinical trials sponsored or co-sponsored by KCL, governance checks are undertaken by the lead partner Trust involved in the study. Once your protocol is written and your ethics submission is drafted, the lead R&D office will undertake sponsor checks. If your study is a CTIMP, the lead R&D office will also allocate a KHP-CTO CRA to support the regulatory compliance of your study.

The SOECAT research element flows to recruiting study sites
The Model non-Commercial Agreement (mNCA) used between the lead organisation and the recruiting sites includes the distribution of SOECAT research funding. Click here

Co-applicant costs flow via a collaboration agreement
After the main funding agreement is signed, the lead organisation will put in place a collaboration agreement between all host organisations of the grant co-applicants.

Other costs will flow via subcontracts
Any subcontracts required must be put in place – for example for placebo manufacture, or any external service providers. Compliance with KCL procurement policies is necessary and some contracts may need to go to tender, so this should be considered when planning grant timelines.