Amendments are changes made to a research study after favourable ethical opinion or approval by MHRA has been given. These changes can be made to the protocol, essential documentation considered as part of the NHS Permission process, or other aspects of a study’s arrangements. Any amendment to a research protocol should have a corresponding amendment to the date and version number of the protocol.
An amendment to a research project can be either substantial or minor (non-substantial) in nature. A favourable opinion from the main REC and/or MHRA approval must be received before amendments can be implemented except where Urgent Safety Measures need to be taken.
Amendments to a study are regarded as ‘substantial’ when they have a significant impact on:
- the safety or physical or mental integrity of the subjects
- the scientific value of the project
- the conduct or management of the study
- the quality and safety of any investigational medical product used a clinical trial (CTIMP).
A ‘non-substantial’ amendment can be defined as a change to the details of a study which will have no significant implication for participants, the conduct, management or scientific value of a clinical trial.
The Research Office must be notified of all amendments made to studies sponsored and/or hosted by Royal Brompton and Harefield hospitals. Confirmation of the continuity of NHS Permission must be obtained from the Research Office prior to any substantial amendments being implemented.
Where Royal Brompton and Harefield hospitals is the trial Sponsor of a CTIMP, the Research Office reviews and authorises all study amendments in line with the SOP for management of amendments to CTIMPs sponsored by Royal Brompton and Harefield hospitals. Please send a draft notification of the amendment to firstname.lastname@example.org.
Amendments for NIHR Portfolio studies should be submitted in line with the ‘New process for handling amendments to NIHR CSP studies'. (need link)
For non-NIHR Portfolio studies, all applicable regulatory approvals (REC, MHRA etc) and amended documents, including signatures if required, should be forwarded electronically to the Research Office: (need link)
For non-commercially sponsored studies please contact:
Non-commercial research manager (020 7351 8736).