The Alfred has developed a policy on long-term storage of research
records. It has been guided by:
-
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
Storage of Research
Records policy and Archive Record form (MS Word)
All clinical and
research records involving
interventional studies are
to be maintained indefinitely by the Hospital, unless deemed otherwise by
the Ethics Committee.
If your
study is interventional and you believe it
does not need to be stored indefinitely, please provide reasons in
your final
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
final
report
is submitted to the Ethics Committee).
Archiving
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
Storage of Research Records policy.
Labeling
instructions, bar coded stickers and transportation details will be
provided by the Research & Ethics Unit once materials have been packed in
the archive boxes and you have forwarded your completed Archive Record
form to us.
Documents
will be stored off-site with Recall Total Information Management and the
cost will be borne by the Hospital.
Archived
material is stored at:
Recall Total Information Management
451-465 Plummer St
Port Melbourne, Victoria
Please
contact
Anna Parker if you have any archiving queries.
Access to stored material
Contact Anna Parker at the
Research & Ethics Unit, if you wish to access or retrieve material once it
has been stored off-site.
Outside agencies
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
Storage of Research
Records policy. 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.
Commercial
sponsors
At
present, some commercial sponsors store completed study documentation
off-site at their own expense. Researchers are to liaise with the Ethics
Manager, Research & Ethics Unit, if they have been involved in studies
stored in this way or if the sponsor requests to store ongoing or future
studies themselves.