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All projects must be submitted to the Melbourne Health HREC both electronically and in hard-copy format. For details on HREC Project Numbers, number of copies, fees and other requirements, please read below.
MHREC FEES Projects will not be accepted without payment. For comprehensive information on HREC fees, please visit the Application Fees Web Page.
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MHREC PROJECT NUMBERS Prior to submitting your application, please contact Ms Michelle Clemson on (03) 9342 7215 to obtain a Mental Health HREC Project Number. The Project Numbers are given out during the week before the Submission Deadline.
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HARD COPIES For each module completed, submit the original plus ten (x10) collated copies in numerical order of the modules. 10 copies of the Participant Information and Consent Form and Protocol are also required. Please submit the original application single-sided and the ten copies double-sided.
Copies to be sent to: Ms Michelle Clemson 6 East, Main Block The Royal Melbourne Hospital PARKVILLE VIC 3050
The Project Number must appear in the top right-hand corner of all hard copies on each of the Modules.
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ELECTRONIC COPY Researchers must also submit an electronic copy of all parts of their MHREC submission. The MHREC Project Number must be included in both the email subject field and in the individual file names. For further details, read the Electronic Submission Procedure.
Electronic Submission Procedure An e-copy of all the documents, with the exception of Clinical Investigator Brochures, is mandatory. Applications which do not meet the submission requirements in full by 4.00pm on the MHREC deadline day will not be accepted.
The address for electronic submissions is: mhrecsubmissions@mh.org.au
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. Projects submitted that do not follow the format below will not be considered and will be returned via email to sender.
Modules (Word Format Only) Module One MHREC NNNN.NNN Module Two MHREC NNNN.NNN Module Three MHREC NNNN.NNN Module Four MHREC NNNN.NNN Module Six Form 1 MHREC NNNN.NNN Module Six Form 2 MHREC NNNN.NNN Module Six Form 3 MHREC NNNN.NNN Module Six Form 4 MHREC NNNN.NNN Module Six Form 5 MHREC NNNN.NNN Module Six Form 6a MHREC NNNN.NNN Module Six Form 6b MHREC NNNN.NNN Module Six Form 7a MHREC NNNN.NNN Module Six Form 7b MHREC NNNN.NNN Module Six Form 8a 8b MHREC NNNN.NNN Module Six Form 8c MHREC NNNN.NNN Module Six Form 9 MHREC NNNN.NNN Module Six Form 10 MHREC NNNN.NNN Module Six Form 11 MHREC NNNN.NNN Module Six Form 15 MHREC NNNN.NNN
EXAMPLE: For instance, if your MHREC project number is 2006.915, the file name for the first module will be: Module One MHREC 2006.915
Participation and Information Consent Form (Word Format Only) PICF MHREC NNNN.NNN Third Party Information and Consent Form MHREC NNNN.NNN
Protocol (Word or PDF Format) Protocol MHREC NNNN.NNN
Other Enclosures If you have any other enclosures such as questionnaires, patient diary/card or advertisements, please clearly state what they are and then add MHREC NNNN.NNN ____________________________________________________________________________
CLINICAL TRIALS Further documentation is required for Clinical Trials. As well as submitting the original plus ten (x10 copies, you must also submit the following:
Two (x2) copies of the Clinical Investigator's Brochure
One (x1) copy of the CTN Form, signed by the sponsor, per each site
Three (x3) indemnities, signed by the sponsor, per each site
One (x1) copy of the Insurance Certificate
Three (x3) copies of the Clinical Trial Agreement, signed by the sponsor, per each site.
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