Download Database Registration Form (DRF)

DATABASE REGISTRATION FORM
(DRF)
This form is to be used to register an RCH Clinical Database (of RCH patient clinical data) in
which the primary purpose is clinical, however a secondary purpose may be research.
The database may then be access 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 us as a Research database with necessary HREC approval; see New Applications
Please fill this form in electronically and submit to Research Ethics & Governance
(Note: if electronic signatures are not used then a hard copy with signatures is required)
Section 1: Database Details
1.1 Name of the Database
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1.2a Database Custodian Name
i.e. person responsible for the database
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1.2b Database Custodian email
Please provide a valid RCH email address
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1.2c Database Custodian phone number
Please provide a valid RCH phone number
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1.3 RCH Department (if applicable)
i.e. where the Database is/will be maintained
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1.4 MCRI group (if applicable)
i.e. where the Database is/will be maintained
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1.5 Type of Database
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1.6 Location of Database
i.e. describe exactly where information is kept
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1.7 What is / was the date of Database set
up?
Click here to enter a date.
1.8 What is the primary purpose of the
Database?
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1.9 Is new (longitudinal) data being added
to current patients’ data?
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Please comment:
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1.10 Is data on new patients being added to
database?
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Please comment:
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1.11 Will the Database be kept indefinitely?
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Please comment
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Database Registration Form (July 2016)
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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.
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2.2 What data is stored on the Database?
i.e. describe in general, data that is collected
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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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Section 3: Storage & Security
3.1a How are data labelled?
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
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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.
Choose an item.
3.1b If the data are Identifiable, please justify
why?
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3.3 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 (and/or their parents/guardians)
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
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Database Registration Form (July 2016)
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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 signer from the list (i.e. PI
or Database Custodian). Then follow the prompts to insert an electronic signature.
Database Custodian: I have read the read the Registering, Managing and Using Clinical Data for
Research Procedure and undertake to fulfil the responsibilities assigned to the Database Custodian.
Name:
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Signature:
X
Database Custodian
Head of Department (HoD):
I have read the Registering, Managing and Using Clinical Data for Research Procedure.
Name:
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Signature:
X
Head of Department
Research Ethics & Governance (Office use only)
Comments: Click here to enter text.
Database Registration Form (July 2016)
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Name:
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Signature:
X
Director Research Ethics & Governance
DATE:
Database Registration Form (July 2016)
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