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.
A transition statement
provides the written tool for collecting and sharing information
about a student between professionals and families that includes the student's profile of abilities and strengths,
additional needs that require support, a summary of previous assessments, reports and other relevant
documentation, and the student's current learning profile.