The documentation ranges across the whole spectrum
of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide
summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation
of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide
additional analyses or supporting data for any
items of concern.