Chapter III AUTHORISATION PROCEDURE FOR A SUBSTANTIAL MODIFICATION OF A CLINICAL TRIAL

United Kingdom

1. 15General principles
2. 16Submission of application
3. 17Validation of an application for the authorisation of a substantial modification of an aspect covered by Part I of the assessment report
4. 18Assessment of a substantial modification of an aspect covered by Part I of the assessment report
5. 19Decision on the substantial modification of an aspect covered by Part I of the assessment report
6. 20Validation, assessment and decision regarding a substantial modification of an aspect covered by Part II of the assessment report
7. 21Substantial modification of aspects covered by Parts I and II of the assessment report
8. 22Assessment of a substantial modification of aspects covered by Parts I and II of the assessment report — Assessment of the aspects covered by Part II of the assessment report
9. 23Decision on the substantial modification of aspects covered by Parts I and II of the assessment report
10. 24Persons assessing the application for a substantial modification