Planning clinical trial

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All research should be fully funded and not subsidised by the NHS; there are many avenues open to researchers for applying for research funding. The funder of the research can be a separate organisation from the Sponsor, and there can be multiple funders and multiple sponsors. If a pharmaceutical company is involved in the provision of their drug for your trial they may also wish to be involved in safety reporting.

You may wish to approach a Clinical Manufacturing Organisation for supply of the IMP including packaging and labelling and randomisation services. Involve the OUH contract team early for support on agreements which may need to be put in place for IMP supply, generation of reports i. DSUR and for the awarding of any educational grant.

Registration is compulsory for every clinical trial with at least one site in the European Community, and provides a unique identification number for the trial, the EudraCT Number. Information regarding the submission process can be found on the MHRA website. Applying to conduct a clinical trial - www. You will need to pay a standard application fee to the MHRA and a fee for any amendments submitted after the initial approval until trial completion.

Most journals require many studies to have been listed on an independent, free to access, validated public register. If any third party including commercial involvement, facilities or services from an NHS trust or other university is involved, then contracts and agreements need to be in place prior to trial start.

The OUH contract team will help put these in place.