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 /
1.2a Database Custodian Name
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 Healthphone number /
1.3 Austin Health Department
i.e. where the database is/will be maintained /
1.4 Location of Database
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? / Choose an item. /
1.9 Is data on new patients being added to the database? / Choose an item. /
1.10 Will the database be kept indefinitely? / Choose an item. /
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 /
Section 3: Storage & Security
3.1a How are data labelled?
  • 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
/ Choose an item. /
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 /
Section 4: Consent
4.1a Was/will consent be sought from patients for data to be included in the database? / Choose an item. /
4.1b If yes, what type of consent (if any) was/will be sought for data to be used for future research?
  • Specific: For a project or clinical purpose
  • Extended: Related to certain conditions
  • Unspecified: For all future research
  • No consent was sought for research
/ Choose an item. /
Any comments regarding consent:

4.2 Provide a brief description of the database
i.e. patient population and data stored (to be published on the intranet)
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: /
Signature: / X______
Database Custodian
Head of Department (HoD): I have read the (INSERT POLICY/PROCEDURE HERE).
Name: /
Signature / X______
Database Custodian
Research Ethics & Governance (Office Use Only)
Comments:

Database Registration Form V1.0 20161108 1