I have a substantial amendment to make to a study I submitted using the old NRES application form. Can I use IRAS to submit this amendment?
IRAS generates the NRES Notice of Substantial Amendment form, which applies to all research except Clinical Trials of Investigational Medicinal Products (CTIMPs). For studies submitted using the old NRES application form, you may use the Notice of Substantial Amendment form available at http://www.nres.npsa.nhs.uk/applicants/after-ethical-review/amendments/. Alternatively you can create a basic dataset in IRAS based on the information in your original application in the old NRES application form. You can use this basic dataset to generate a Notice of Substantial Amendment. If the research involves a CTIMP then the Notice of Substantial Amendment must be completed in EudraCT. In the future we plan to add functionality to make it possible to complete the EudraCT Notification of Substantial Amendment form in IRAS.
Related Questions
- I have a substantial amendment to make to a study I submitted using the old NRES application form. Can I use IRAS to submit this amendment?
- What are the required documents that need to be submitted along with the application form?
- When should a modification (amendment) to an approved research study be submitted?
