23 May 2013
During a routine inspection
We telephoned one person who had been selected at initial stages to take part in a clinical trail. We asked how much information they had been given on the trial, what the trial involved, and about their experience from beginning to end. They explained to us, "The screening was very extensive; there were lots and lots of questions I had to answer." We asked how well informed they were about the drug involved in the trial. They told us, "I was given a lot of information about what type of drug was being tested and that it would be administered by self injection. I would have been taught to self administer if I had gone on to be suitable for the trial after the initial appointment with the doctor." We asked if this person had consented to their details being held for selection in future drug trials. They confirmed they had been asked for their consent in writing and had been given written information on how their personal details would be stored. They told us "Staff were very good at explaining what was involved at each stage in the process."
Throughout our inspection we found that people involved in clinical trials were well informed and that their well being was protected.