Amendments to your clinical trial

If you have to make any changes to your research after it has been approved, you will need to seek approval from the relevant regulatory bodies. The changes will be classified as substantial or non-substantial amendments.

If Lancaster University is the Sponsor then all substantial amendments must be approved by the Clinical Trials Sponsorship Committee (CTSC) before submission to NHS REC, HRA, MHRA, NHS Trusts or other clinical trial authorisation.

Non-substantial amendments do not need approval by the CTSC but they do need to be informed of the changes. Please email approval notification from the regulatory bodies to

It is essential to inform the CTSC as they can ensure that indemnity is not affected by the change(s) made to the trials.

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