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Clinical Databases are collections of clinical data which have been created for clinical or administrative use. There are many such databases across the hospital; many of which have been created or modified to allow research as a secondary purpose.
Heads of Department are now responsible for ensuring each clinical database within their department has a Data Custodian. The role of the custodian is to register the database with the Office for Research (OFR), and ensure that data are stored securely, used responsibly and that the privacy of participants is safeguarded. The custodian must also alert the OFR of any changes to the Clinical Database, such as a change in data collected, change in storage or security or change in database custodian.
If you currently have an active clinical audit approved and you wish to continue your audit, please ensure you contact the OFR and submit a DRF/DAF to register the database.
Clinical data is available from either a previously registered clinical database, or a patients medical record. Although the National Statement and the Health Records Act (Vic) 2001 enables clinical data that has already been collected as part of routine clinical care to be accessed for secondary purposes such as evaluation without the need for ethical review, this type of activity still requires review and approval by the OFR prior to accessing and using the data.
To support applications to access clinical data, the OFR have developed the Data Access Form. This review pathway may be used in place of an LNR, when:
This review process does not grant applicants with ethical approval.
It should also be noted that identifiable and re-identifiable health information cannot be transferred outside of the AH IT environment without written consent from participants. There are no exceptions to this in line with the Health Records Act (Vic) 2001 and the Privacy Act (1998).
Please note that if you require any modifications to be made to your approved Database Access Form (DAF), that we require you to submit a new DAF for review and approval, rather than a modification / amendment to your current application.