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Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.

January 14, 2021 In 2020, the COVID-19 pandemic taught the world another lesson about the unpredictability of life. Each country responded to the challenges posed by the pandemic in its own way. The German Government in its familiar technocratic and sober approach quickly unlocked massive financial resources to mitigate any immediate economic damage. It supported a further relaxation of the purse strings at EU level and put legislative acts in place that helped manage the uncertainty in the most affected industries for now. Hit by a second wave of the pandemic in an unexpectedly hard way, Ger...

Guidance on submitting clinical trial safety reports How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). From: Print this page You must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways: If you intend to submit SUSARs using one of the new reporting routes, you must register. For trials ongoing in both the UK and in European member states dual reporting is needed. You will need to report each SUSAR to both the MHRA and relevant member states, as well as ...