When a substantial modification (which needs Research Ethics Committee review) to a Phase 1 healthy volunteer trial is submitted, it will undergo a validation check.
We aim to complete this within 1 working day. If no validation issues are identified, the sponsor will be given confirmation that the submission is valid.
If validation issues are identified, they will be communicated to the sponsor. The sponsor will then have until 7 calendar days from when the modification was submitted to address these validation issues. If the sponsor is able to resolve them in this time, the modification will be categorised as valid.
If the sponsor cannot resolve the issues within this timeframe, the modification will be categorised as invalid. This means the sponsor will then need to resubmit the modification, making sure they address the validation issues that were raised.
Once a modification is confirmed as being valid, an initial review will be carried out by the Research Ethics Committee (REC). Once this is complete, the outcome of the initial review will be communicated to the sponsor. We’ll aim for substantial modifications to Phase 1 healthy volunteer trials to receive an initial outcome from the REC within 21 calendar days of submission.
The outcome of the initial review by the REC will either be a favourable opinion, a favourable opinion with conditions or, if the REC is unable to give a favourable opinion based on the information or documents provided, the REC will send the sponsor a request for further information.
If a request for further information is sent, the sponsor will have up to 60 calendar days to respond. The sponsor can respond at any point within this timeframe.
Once a response to a request for further information is provided, the REC will review it and provide a final decision, which will either be a favourable opinion or unfavourable opinion. This will be done within 10 calendar days of receiving the response.