Obtaining regulatory approval for multicentre randomised controlled trials: experiences in the STICH II trial.

@article{Kenyon2011ObtainingRA,
  title={Obtaining regulatory approval for multicentre randomised controlled trials: experiences in the STICH II trial.},
  author={Gillian M Kenyon and Alexander David Mendelow and Barbara Gregson and Elise N. Rowan},
  journal={British journal of neurosurgery},
  year={2011},
  volume={25 3},
  pages={352-6}
}
BACKGROUND AND PURPOSE Centres wishing to participate in international multicentre randomised controlled surgical trials such as STICH II (Surgical Trial in Lobar Intracerebral Haemorrhage) have to go through a number of regulatory hurdles. These depend on the nature of the study. In surgical studies, there is a need to obtain ethical approval and… CONTINUE READING