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The JRO is piloting a self-service process to review and approve simple, non-substantial amendments for UCL/UCLH sponsored studies within one working day of receipt.
For UCL and UCLH sponsored studies, the JRO is piloting a self-service amendment process. This pilot aims to speed up the JRO review of simple, non-substantial amendments, allowing researchers to proceed to submit to regulators (NHS REC, HRA) quickly.
Under the pilot, the JRO will review and approve eligible non-substantial amendments of UCL and UCLH sponsored studies in one working day of receipt.
The pilot will initially run for a period of 6 months – from 1 October 2025 – and will be subject to review. If successful, the process may be extended and applied to a wider amendment cohort.
Eligibility Criteria
To be eligible for the self-service amendment process, the following criteria must be met:
- The research study must be an existing UCL or UCLH sponsored and not a trial under MHRA remit.
- Researchers should complete the relevant self-service amendment’ form (links below), and as part of this process, provide:
- a completed ‘Amendment Tool’ – access guidance for completing the tool
- clean and tracked-change versions of all documents affected by the amendment
The amendment must be for one or a combination of the following:
- change of Chief Investigator of the study
- change of Principal investigator at a research site
- change(s) to participant inclusion or exclusion criteria/s
- change(s) to participant-facing document(s) - excluding any changes in study procedure(s)
- addition or removal of any patient facing document(s)
- correcting any typo / error in study document(s)
Submission
Researchers should complete the appropriate self-service amendment form below. Please use the form which applies to your study– for either ‘UCL sponsored studies’ or ‘UCLH sponsored studies’. Within each form, users can upload their completed amendment tool and all documents affected by the amendment. Within the form, users can submit all documents and information directly to the JRO.
Upon submission, researchers will receive an automated acknowledgement. The JRO will review and approve eligible amendments within one working day. Researchers may then proceed to submit their amendment to the NHS REC and/or HRA in line with usual process.