Purpose Of The Requirement

B. Purpose of the requirement:

The new requirement was implemented in UK legislation in order to:

1. Enhance the safety of trial subjects/patients by seeking to ensure that the licensing authority is promptly informed of such serious breaches, in order to take appropriate action in response to the breach and/or,

2. To take the information regarding serious breaches into account when assessing future applications for clinical trial authorisation, and applications for marketing authorisation, which include data from trials affected by serious breaches.

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