Essential study documents can be defined as those that collectively allow the evaluation of the conduct of the study and the quality of data and results produced. During the study they should all be kept filed in an Investigator Site File or a Study Master File as to assist with the management of the study. The Research & Development Dept. has created a template for an Investigator Site File.
Following conclusion of the study, essential documents and study data should be archived in legible condition for a sufficient length of time to allow for audit and inspection by regulatory authorities and should be available on request. For studies that involve the use of an IMP (Investigational Medicinal Product) the minimum period for archiving following completion of the trial is 15 years (EC commission directive 2003/63/EC).
However, for studies that do not involve regulatory submissions i.e. those that do no involve the use of an IMP, the minimum period for archiving should be at least five years after completion of the study. This is the joint guidance issued by the Department of Health (DoH) and the Medical Research Council (MRC).
Essential documents and data should be stored in a secure lockable location with access restricted to authorised personnel and should be clearly labelled with the earliest possible date on which they can be destroyed or disposed of.
The Department of Health has published a list of links to relevant legislation, policies and sources of information relating to retention of records.