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All substantial amendments will be presented to the METC and to the competent authority.
All substantial amendments to the original approved documents will be also sent to an appropriate Ethics Committee and Regulatory Authority for written approval.
All substantial amendments to the original approved documents will also be sent to an appropriate Ethics Committee (EC) and Regulatory Authority for written approval.
All substantial amendments will be submitted to the ethics committee for their approval prior to implementation (see online supplementary appendix 8).
All substantial amendments made will be reviewed by the sponsor prior to submission to the REC and the MHRA for their approval; substantial amendments will also be notified to all participating research sites.
All substantial and non-substantial amendments as well as respective regulatory approvals will be provided electronically via the Integrated Research Application System (IRAS) to the Clinical Research Network North West Coast who will notify the Research and Development Department at individual participating sites for local approval and implementation.
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