The Research and Development (R&D) Governance team must be notified of any minor, substantial or urgent safety study ammendments. Many study amendments will run in parallel with gaining R&D approval.
A substantial amendment is defined as a change that is likely to affect any of the following to a significant degree:
- Safety or physical or mental integrity of trial participants
- Scientific value of a trial
- Conduct or management of a trial
- Quality or safety of investigational medicinal products used in a trial
Substantial amendments include:
- a change of sponsor
- appointing a new chief investigator
- a new research site in a study requiring a site specific assessment consideration of local issues in a multi-centre study
- appointing a new research site principal investigator
- changing inclusion or exclusion criteria
- recruitment process changes
- extending a study that has the potential to generate significant cost implications
Researchers must not implement substantial amendments until receiving approval from the Medicines and Healthcare products Regulatory Agency (MHRA), Research Ethics Committee (REC) and the R&D team, unless patient safety would be compromised.
Minor amendments cover changes such as:
- correcting typographical errors in protocol or other study documentation
- appointing new support staff
- documentation changes for recording study data
- logistical arrangement changes for storing or transporting samples
Although R&D approval is not required for minor amendments, the principal investigator must notify R&D Governance of all study amendments.
Who decides if an amendment is substantial?
Trial sponsors have the legal duty to decide on medicinal product clinical trial amendments. The R&D Governance team should be contacted if University Hospitals Birmingham NHS Foundation Trust (UHB) is the trial sponsor. The REC will make decisions on all other research.
Contact the R&D Governance team or the REC for further advice on submitting a minor or substantial amendment.
The R&D Governance team should be notified of all amendments.
Study amendments can be reported by sending copies of the National Research Ethics Service (NRES) amendment form and new versions of the protocol or supporting documentation to the R&D Governance team.
Failure to notify the R&D Governance team of an amendment could result in the study being suspended, closed or investigated under the scientific misconduct procedure.
As well as notifying the R&D Governance team, the chief investigator or sponsor may also be required to report amendments to:
- REC – for all substantial amendments
- MHRA – for substantial amendments to a clinical trial of an investigational medicinal product (CTIMP)
- the participating site principal investigator and R&D offices – for all amendments
Full R&D approval will be issued once REC and MHRA approvals have been provided to the R&D Governance team. Substantial amendments will be authorised by the head of R&D Governance.
See the NHS Health Research Authority (HRA) website for more information on reporting amendments.
Urgent safety measures
In the interest of study participants, urgent safety measures may be implemented without delay.
The REC, MHRA, study sponsor and R&D must be notified of any urgent safety measure amendments immediately. A substantial amendment should be reported within three days that documents the reasons for the measures taken.
Last reviewed: 28 April 2021