DATABASE ACCESS FORM
(DAF)
THIS FORM IS TO BE USED WHEN:
o A research project requires ONLY access for research purposes to:
 Clinical data from a REGISTERED clinical database – if the database has not
yet been registered you may NOT use this form. Contact Research Ethics &
Governance (REG) with questions.
 Research data from an approved research database
 Medical records, IBA or CLARA
o A Quality Improvement (QI) project has been completed using existing clinical or research
data and a subsequent decision has been made to publish the results.
THIS FORM IS NOT BE USED IF:
o If the research project involves procedures other than simply accessing a database, in which
case an application to HREC will need to be completed (including contacting patients or their
parent/guardians).
o If identifiable data will be accessed by staff who do not have rightful access and consent was
not obtained to use this data for research; a New Application for ethics approval is required.
o If there is a reasonable expectation that the research findings arising from the project may
have an impact on the clinical care of patients. An application for ethics approval as per the
guidelines on RDE Office website New Application needs to be made.
o If the project is Quality Improvement (QI) and there is no intention to publish the results.
PLEASE NOTE:
1. Please complete either this Data Access Form OR an LNR application NOT BOTH
2. Databases on campus must be registered with Research Development & Ethics before approval
is granted to access them for research purposes using this form. Contact REG with questions.
3. Data Custodians are required to approve access (signature on last page).
Please fill this form in electronically and submit to REG
(Note: if electronic signatures are not used then a hard copy with signatures is required)
Section 1: Application & Applicant Details
1.1 Project Title
Click here to enter text.
1.2 Approval Period Required (up to 5 years)
Choose an item.
1.3 Principal Investigator (PI)
Must be affiliated with MCRI/RCH/UoM
Click here to enter text.
1.4 PI email address
Click here to enter text.
1.5 PI phone number
Click here to enter text.
1.6 RCH Department (if none, type N/A)
Click here to enter text.
1.7 MCRI Department (if none, type N/A)
Click here to enter text.
1.8 University of Melbourne Department
Click here to enter text.
(if none, type N/A)
Section 2: Database Details
2.1 From which clinical database (or research
project) will data be used?
i.e. database/project name or Medical Records
2.2 Database (or HREC) Registration Number
2.3a Do you have rightful access to the data?
i.e. part of the treating team or department (for
clinical data), or part of the investigative team (for
research data)
Comment if necessary
2.3b Are you using De-identified data?
NOTE: if Identifying information will be removed
prior to use then tick Yes.
If no, provide justification:
2.3c Have patients or their parents/guardians
provided consent for their data to be used in
this manner (i.e. for this research project)?
If yes, please attach a copy (example)
Comment (if needed):
Click here to enter text.
Click here to enter text.
Choose an item.
Click here to enter text.
Choose an item.
Click here to enter text.
Choose an item.
Click here to enter text.
If No to ALL of 2.3a-c above, you will need to complete an ethics application at
Research Ethics & Governance: New Applications
2.4a Is data being provided to an institute
external to the campus?
(Must be transferred in a de-identified form)
Choose an item.
2.4b If yes, have you attached the:
1) Institutional HREC approval (from the
external institute); and
2) Material Transfer Agreement
Choose an item.
Section 3: Participant Details
3.1 What patient population is to be studied?
e.g. patients aged between 5-10 yrs who
underwent emergency appendectomy.
Click here to enter text.
3.2 Approximately how many patient medical
records or datasets will be used?
Please notify HIS if large numbers of medical
records are to be requested (>50).
Click here to enter text.
Section 4: Project Protocol
4.1 Provide a background for the project including rationale and aims (1 page) e.g. How will the
information learned from the project allow the researchers to better understand the natural history of the
disease or aid in better diagnosis and outcomes for patients?
Click here to enter text.
Database Access Form (April 2014)
Page 2 of 4
4.2 Describe any foreseeable ethical issues and how they will be addressed; including risk to
patient privacy and relevance to clinical care e.g. will the research generate new information that will
have direct implications for patient clinical management?
Click here to enter text.
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.
Principal Investigator (PI): I agree to access and use data exclusively for the purpose described above,
and will not pass the data on to a third party.
Name:
Click here to enter text.
Signature:
X
Principal Investigator
Database Custodian (for clinical database) OR Principal Investigator (for research databases):
I am satisfied with the proposed use of the data and will allow the Principal Investigator access to reidentifiable or non-identifiable data when approval for the research is granted by the Ethics Office.
Note:
1. Please contact Research Ethics & Governance for the Database Custodian name if unknown.
2. Please print this page multiple times when multiple databases are to be accessed and thus multiple
data custodian sign-offs are required.
3. A signature is not required for Medical Records, IBA or CLARA access.
Name:
Click here to enter text.
Signature:
X
Database Custodian
Research Ethics & Governance (Office use only)
Comments: Click here to enter text.
Name:
Click here to enter text.
Database Access Form (April 2014)
Page 3 of 4
Signature:
X
Director Research Ethics & Governance
Database Access Form (April 2014)
Page 4 of 4