Some noteworthy quotes

"I won't actually be doing the work, my ... will be, but you can't meet them today because they are off somewhere else."

(At a study or site initiation visit): "I'll be getting the patients from several other clinics/outpatients, but I am not quite sure which ones I will use yet, I will let you know."

(At a monitoring visit): "I don't have the patient's records here, but if you know what the questions are, I will follow them up and send the answers to you."

It is common practice, in fact some people would say the norm, for the principal investigator not to be the person who will actually do the work. Under these conditions it is essential that the company be given access to the staff who will be ultimately responsible for carrying out the studies. It is all too easy for a prestigious or busy unit to take on more and more work in the hope, without checking, that the junior staff can cope with it. Under these conditions unreasonable pressures are brought to bear on junior staff, fearful for their future, to complete the studies.

To illustrate some of the problems a further case study is useful.

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