Study start delays and approvals

Hi there,

MHRA and REC assume research commences within 12 months of approval.
Explanations should be provided if it doesn’t commence within 12 months and further explanation after 24 months.
One study I am working on has had more than 32 months delay. What are the chances of the study being terminated or required for resubmission?

It's possible that the study might be subject to scrutiny by the MHRA and REC. They may require a detailed explanation for the delay and assess whether the reasons provided are acceptable. If the explanations are not satisfactory, there is a chance the study could be terminated or required for resubmission.