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Transcript
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 Click here to enter text. 1.2a Database Custodian Name Click here to enter text. 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 Click here to enter text. Click here to enter text. i.e. where the database is/will be maintained Click here to enter text. 1.4 Location of Database Click here to enter text. 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? Click here to enter text. Click here to enter text. Choose an item. Choose an item. 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 Database Registration Form V1.0 20161108 Click here to enter text. Click here to enter text. Click here to enter text. 1 3.1a How are data labelled? Section 3: Storage & Security Choose an item. 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 Click here to enter text. Click here to enter text. Section 4: Consent 4.1a Was/will consent be sought from patients Choose an item. 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? 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: Click here to enter text. 4.2 Provide a brief description of the database i.e. patient population and data stored (to be published on the intranet) Click here to enter text. Database Registration Form V1.0 20161108 2 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: Click here to enter text. Signature: X________________________________ Database Custodian Head of Department (HoD): I have read the (INSERT POLICY/PROCEDURE HERE). Name: Click here to enter text. Signature X________________________________ Database Custodian Research Ethics & Governance (Office Use Only) Comments: Click here to enter text. Database Registration Form V1.0 20161108 3