Access to stored material
The Alfred Hospital
Ethics Committee has developed guidelines
for long-term storage of research
records. The guidelines address:
the need to maintain full study records for
a sufficient time to resolve scientific queries and challenges that may
arise after completion of the study
the need to ensure that study records are
disposed of carefully or in a fashion that will not compromise the
privacy of study participants and confidentiality of the study data
Archiving / Storage of
Research Records Guidelines
Archive Record (MS
All clinical and
research records involving interventional studies are
to be maintained indefinitely by the Hospital, unless deemed otherwise by
the Ethics Committee.
study is interventional and you believe it
does not need to be stored indefinitely, please provide reasons in
progress report. Records for
non-interventional studies, standalone questionnaires and surveys
should be retained for seven years
after completion of the study (taken from the date at which the
is submitted to the Ethics Committee).
On completion of all research studies, sufficient
information should be stored to reconstruct the data analysis if required.
Study records must be
packed and labeled in accordance with the
Archiving / Storage of Research Records
instructions, bar coded stickers and transportation details will be
provided by the Ethics
Office once materials have been packed in
the archive boxes and you have forwarded your completed
Archive Record to us.
will be stored off-site with Recall Total Information Management and the
cost will be borne by the Hospital..
material is stored at:
Recall Total Information Management
451-465 Plummer St
Port Melbourne, Victoria
Anna Parker if you have any archiving queries.
Access to stored material
Anna Parker at the
Ethics Office, if you wish to access or retrieve material once it
has been stored off-site.
Where principal researchers work outside The Alfred, their research
documentation would normally be stored elsewhere, eg at universities and
other institutions. Such documents should now be archived according to the
Research Records Guidelines. Alfred contact persons or co-researchers for such studies should take
steps to communicate this information to outside agencies. A
draft letter can be
used as a template for this purpose
present, some commercial sponsors store completed study documentation
off-site at their own expense. Researchers are to liaise with the Manager,
Ethics & Research Governance, if they have been involved in studies
stored in this way or if the sponsor requests to store ongoing or future