The JRCO will be notified of all amendments (whether substantial or non-substantial) and assess whether there will be any impact on governance arrangements or resources. No amendment can be implemented without JRCO approval.

An amendment is defined as substantial if it is likely to affect, to a significant degree, the safety of the subjects, the scientific value of the trial or the quality or safety of any investigational medicinal product used in the trial. Examples include:

  • change - relating to sponsor(s), inclusion or exclusion criteria, recruitment process
  • appointments - a new chief investigator, a new principal investigator at a research site
  • new research site - requiring a site-specific assessment of local issues in a multi-centre study

In all cases, report amendments to the JRCO at the contact details below.

Resources

TypeWhere to find
Key contacts JRCO
Useful links NIHR CRN - amendments
NIHR Clinical Trials Toolkit - safety measures
NIHR Clinical Trials Toolkit - substantial amendments
NIHR benchmark Post NIHR 70-day benchmark
Process map links This activity occurs in the recruitment stage:
Imperial College London as sponsor
Imperial College Hospital NHS Trust as sponsor
Commercial organisation as sponsor
Non-commercial organisation as sponsor