Download Database Registration Form (DRF)

AUSTIN HEALTH DATABANK REGISTRATION FORM
This form is to be used to register an Austin Health Clinical Database (of Austin Health patient clinical data) in which the
primary purpose is clinical, however a secondary purpose may be research.
The database may then be accessed for research by submitting a Data Access Form (DAF).
Please note: New databases which are created primarily for research (or contain research information) must be set up as a
research database with necessary HREC approval; see New Applications.
Please fill this form in electronically and submit to the Office for Research
(Note: if digital signatures are not used, then a hard copy with signatures is required, alongside the electronic version).
Section 1: Database Details
1.1 Name of the Database
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1.2a Database Custodian Name
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i.e. person responsible for the database
1.2b Database Custodian email
Please provide a valid Austin Health email address
1.2c Database Custodian phone number
Please provide a valid Austin Health phone number
1.3 Austin Health Department
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i.e. where the database is/will be maintained
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1.4 Location of Database
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i.e. describe exactly where the information is kept
1.5 What is/was the date of database set up?
1.6 What is the primary purpose of the
database?
1.7 Is new (longitudinal) data being added to
current patients’ data?
1.9 Is data on new patients being added to the
database?
1.10 Will the database be kept indefinitely?
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Section 2: Patient (Data) Details
2.1 Participant population
i.e. whose data is included in the database e.g. specific
conditions, clinical characteristics, etc.
2.2 What data is stored on the database?
i.e. describe in general the data that is collected
2.3 What was/is the source(s) of the data?
e.g. medical notes, surgical reports, hospital medical
records, test results
Note: Information may have been collected as part of
routine care, for quality assurance activities or for research
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3.1a How are data labelled?
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Section 3: Storage & Security
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Identifiable – Labeled with identifiers e.g. name,
UR number, DOB, contact details
Re-identifiable – Coded using a numbering
system that is unique to this project and the key
to the code is kept in a separate, secure file
Non-identifiable – All links with the source of the
data are permanently broken and it is not
possible to link the data with the data source
3.1b If the data are identifiable, please justify
why?
3.2 Who has access to the database?
e.g. Head of Dept, Consultants, Dept Staff
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Section 4: Consent
4.1a Was/will consent be sought from patients
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for data to be included in the database?
4.1b If yes, what type of consent (if any) was/will Choose an item.
be sought for data to be used for future
research?
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Specific: For a project or clinical purpose
Extended: Related to certain conditions
Unspecified: For all future research
No consent was sought for research
Any comments regarding consent:
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4.2 Provide a brief description of the database
i.e. patient population and data stored (to be published on the intranet)
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Agreement & Signatures
NOTE: A signatures ribbon will appear at the top of the screen. To add electronic signatures please click ‘view signatures’
and choose ‘sign’ on the appropriate signatory from the list (i.e. PI or database custodian). Then follow the prompts to
insert an electronic signature.
Database Custodian: I have read the (INSERT POLICY/PROCEDURE HERE) and undertake to fulful the
responsibilities assigned to the Database Custodian.
Name:
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Signature:
X________________________________
Database Custodian
Head of Department (HoD): I have read the (INSERT POLICY/PROCEDURE HERE).
Name:
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Signature
X________________________________
Database Custodian
Research Ethics & Governance (Office Use Only)
Comments:
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