Chief investigators must submit a development safety update report to the MHRA and the REC once a year throughout the clinical trial or on request.
The report should take into account all new available safety information received during the reporting period.
A data lock point should be set based on the date of the first CTA approval of the IMP or, for trials with marketed products, the date of the first marketing authorisation granted in the EU.
The DSUR must be submitted no later than 60 calendar days from the data lock point.
A progress report should be submitted to the main REC annually on the anniversary of the date on which the favourable opinion was given.
A copy must be sent to CTRG and the relevant NHS R&D office (if applicable).
Recruitment numbers must be reported to the host organisation.