Monitoring/Investigating and Reporting Conditions

The level of uncertainty about an adverse effect can usually be significantly reduced by a well designed monitoring or investigation programme. Such conditions can be combined with other conditions designed to address uncertainty, including a trigger and response condition (above) and a review condition (below). Monitoring conditions are particularly important if consent is granted for a short-term because of concerns about a specific adverse effect.

A monitoring/investigation condition can help ensure critical additional information is available as part of a further future process such as: (i) a new consent application, (ii) an application to change or (iii) a review conditions of a consent condition.