The Research Governance and Integrity team 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 Research Governance and Integrity team at the contact details below.
Resources
| Type | Where to find |
|---|---|
| Key contacts | Research governance and integrity |
| 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 |