NHS Research Ethics Committees (RECs) are required to monitor research that has received a favourable opinion.
A progress report should be submitted to the REC which gave the favourable opinion (the ‘main REC’) 12 months after the date on which the favourable opinion was given. Annual progress reports should be submitted thereafter until the end of the study.
Study commencement date
The first annual progress report should state the commencement date for the study. This is normally assumed to be the date on which any of the procedures in the protocol are initiated.
If the study has not started within 12 months of the favourable opinion, you should give an explanation for the delay in the first progress report.
Extension of the period of the study
If the chief investigator plans to extend the duration of the study beyond the period specified in the application form, you should notify the main REC in writing, giving reasons for the extra time needed to complete the research.
Extension of the study period is not in itself a substantial amendment, except where it is related to other amendments that would be substantial. You do not need to obtain a favourable ethical opinion from the REC for extension of the study period.