Screenshot showing a box containing Amendment Details. Select the questions sets you wish to modify. The screenshot shows all the following options are deselected; study information, medicines information, is this amendment related to an Urgent Safety Measure (USM)?
The amendment details box then asks you to; Select the review bodies as given in Section 4 of the completed Amendment Tool for this amendment. This field is marked as mandatory. The options that appear are; Component Authority MHRA - Medicines, Research Ethics Committee. The following contextual help appears underneath the Research Ethics Committee option; Use the amendment tool as IRAS Help - Maintaining your approvals- Amendments (myresearchproject.org.uk) to describe your amendment. Select the Competent Authority - MHRA Medicines and/or Research Ethics Committee or both as indicated by section 4 of the completed amendment tool. Upload the completed amendment tool as a document to accompany your amendment.
You must then summarise the amendment changes in 4000 characters or less.
You can then select either a Submit or Save button.