Database Access Form May 2016) Page 2 of 4

DATABASE ACCESS FORM
(DAF)
THIS FORM IS TO BE USED WHEN:
o A project requires access to:
· Clinical data from a REGISTERED RCH clinical database e.g. EMR. 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 (with participant
THIS FORM IS NOT BE USED IF:
o If the research project involves procedures other than simply accessing an RCH clinical database for clinical evaluation or quality assurance type work;
o If patients or parents need to be contacted for further information;
o If data from other organisations will also be used as part of the project;
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; or
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.
NOTE: In each of the above cases a New Application for research ethics approval is required.
PLEASE NOTE:
1. Please complete either this Data Access Form OR an New Application NOT BOTH
2. Databases on campus must be registered with Research Ethics & Governance 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
(if none, type N/A) / Click here to enter text.
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 / Click here to enter text.
2.2 Database (or HREC) Registration Number / Click here to enter text.
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) / Choose an item.
Comment if necessary / Click here to enter text.
2.3b Are you using De-identified data?
NOTE: if Identifying information will be removed prior to use then tick Yes. / Choose an item.
If no, provide justification: / Click here to enter text.
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) / Choose an item.
Comment (if needed): / 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.
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: /
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 re-identifiable 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 EMR or IBA access.
Name: / Click here to enter text.
Signature: /
Research Ethics & Governance (Office use only)
Comments: Click here to enter text.
Name: / Click here to enter text.
Signature: /