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Following approval
Once your study has been granted a favourable opinion from an NHS REC and NHS Permission from the host Trust, you can then start your project (please see note below), but this does not mean that your dealings with Research & Development come to an end.
As part of the duty of care to their patients and staff all NHS Trusts hosting research have a responsibility to monitor the progress of all research to ensure the continued safety and well being of those to which they owe a duty of care. This includes those actively participating in research as well as ensuring that ongoing research does not have any adverse impacts on the services provided by the Trust.
Note
If you require an honorary research contract or Letter of Access for your study, these will, in most circumstances, be issued at the time of NHS Permission. This however may not always be possible, particularly if CRB clearance is required. Although you may start your study you MUST NOT have any patient contact or access to any patient identifiable information until your honorary research contract or Letter of Access has been issued.
If you require an honorary research contract or Letter of Access for your study, these will, in most circumstances, be issued at the time of NHS Permission. This however may not always be possible, particularly if CRB clearance is required. Although you may start your study you MUST NOT have any patient contact or access to any patient identifiable information until your honorary research contract or Letter of Access has been issued.
Monitoring of progress can take several formats:
Review of study amendments
Annual Progress monitoring
Research Audit
Investigation of incidents and complaints
Safety / Adverse Event Reporting
These requirements are in addition to any other monitoring requirements of other review bodies such as the NHS REC or MHRA.
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