The final study is an extended monitoring visit provided by Prodia the CRO which will be checked accordingly and contains certain extra requirements.
1.To account for all drug supplies used and to collect all remaining unused drug supplies or to discuss appropriate destruction of unused supplies if appropriate.
2.To collect all other study supplies (unused case report forms, extra protocols, brochures, unused specimen containers etc.)
3.To review and collect final completed case report forms.
4.To complete documents of study file
5.To remind the investigator concerning his obligation to provide an appropriate clinical report if such has been specified, within the allotted time scale
6.To discuss as necessary, publication plans of the results of the study