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the categorisation system used across the NHS/HSC to identify which amendments require action by NHS/HSC R&D offices and which do not
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what kind of activities do not need to be notified as amendments
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good practice for grouping amendments together
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good practice for new site amendments
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the process for submitting amendments – which varies depending on which UK nation the lead NHS/HSC R&D office for the study is based.
Mary Cubitt, Four Nations NHS/HSC Compatibility Programme Manager said “It may sound obvious but we strongly recommend that people submitting amendments carefully read all the correspondence they receive after submitting amendments as it will provide information on what to do next and prevent delays and wasted effort.”
Dr Janice Bailie, Assistant Director of HSC R&D Division said "The release of this guidance is the first step towards improving consistency for cross-border studies. I would like to thank colleagues across the HSC R&D Application Gateway and the Trust R&D offices for supporting this process."
For more information and guidance about research approval in HSC click here>