Study start delays and approvals

[nkaur]

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?

[james21]

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.