Chapter VII SAFETY REPORTING IN THE CONTEXT OF A CLINICAL TRIAL

United Kingdom

1. 40Electronic database for safety reporting
2. 41Reporting of adverse events and serious adverse events by the investigator to the sponsor
3. 42Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency
4. 43Annual reporting by the sponsor to the Agency
5. 44Assessment by Member States
6. 45Technical aspects
7. 46Reporting with regard to auxiliary medicinal products