The Department of Health has published a list of links to relevant legislation, policies and sources of information relating to the retention of records from research involving the NHS.
The Principal Investigator (PI) is responsible for making arrangements for archiving on completion of the study. The Research & Development Dept. has prepared guidance notes on archiving.
On completion of the study, the PI should submit a Project Archiving Record Form to the Research & Development Dept.
A template is available which should be used to label archive boxes for all CTIMP studies (Clinical Trials of Investigational Medicinal Products). This template is for use with Avery Parcel labels L7165 which can be ordered through the EROS system.
I am the Principal investigator of a study that is approaching its conclusion. The study is questionnaire based and does not involve the use of an Investigational Medicinal Product (IMP). How long do I need to archive study data and essential study documents & records for after the study concludes?
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 and Development Department 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 reason for destruction/disposal of essential documents should be documented and this record should be retained for a further five years from the date of destruction/disposal.
The Department of Health has published a list of links to relevant legislation, policies and sources of information relating to retention of records from research involving the NHS.
See also some frequently asked questions relating to archiving study documents.