Department of Research and Innovation
HREC - Information for sponsors/CROs
Meeting Schedule
CDD HREC meetings are held on the second Tuesday of the month, on a bi-monthly basis, that is, the first meeting of the year is in February and the last in December. Submission Schedule
All submissions must be received by the CDD Research Department 13 working days prior to scheduled meeting. The Research Department will arrange appropriate cover letters and make the submission to the CDD HREC.
Important Dates for 2010/2011
Upcoming meeting dates:
| Meeting Date | Submission Date |
|---|---|
| 9 February 2010 | 22 January 2010 |
| 13 April 2010 | 26 March 2010 |
| 8 June 2010 | 21 May 2010 |
| 10 August 2010 | 23 July 2010 |
| 12 October 2010 | 24 September 2010 |
| 14 December 2010 | 26 November 2010 |
| 8 February 2011 | 21 January 2011 |
New submissions
All new submissions must include:
- x16 copies of the Protocol
- x16 copies of the Patient Information & Consent form*
- x7 copies of the Investigator Brochure
- x16 copies of any other patient materials, including letters, diaries, advertisements etc.
- x16 copies of Notification of HREC Applications in Australia**, if applicable.
*Important Note 1: The CDD HREC has a preferred format for the Patient Information & Consent Form. Please view template via above link. Template is based on a double-blind, randomised, controlled study.
**Important Note 2: The CDD HREC requires notification of other HRECs reviewing/approved the project. Please view template via above link.
CDD will prepare a submission covering letter, as per the CDD HREC preferred standard format. Any specific Sponsor/CRO requirements for Submission Letters i.e. version number/date preferences etc, must be specified to the study coordinator at the time of submission, otherwise standard formatting will be used. Approval Letters will be issued according to the information provided in the Submission Letter. If this information differs to the Sponsor/CRO requirements, and was not communicated to the study coordinator prior to submission then changes to Approval Letter format will not be made retrospectively.
If the Sponsor wishes to submit using the NEAF application, this is acceptable.
Please note that the CDD HREC will only provide an Acknowledgement Letter for submitted Investigator Brochures.
Resubmission / Amendments
All resubmissions and amendments must include:
- x16 copies of all amended documents (except Investigator Brochure)
- x 7 copes of amended Investigator Brochure, if applicable.
- x16 completed Amendment Submission form The Amendment Submission form must be completed by the Sponsor/CRO and signed by an authorised representative. Please use link to access the form.
- x16 copies of Notification of HREC Applications in Australia, if applicable.
Each resubmission or amendment will result in a change in the version number. Preferred version numbering changes would be for example from 'Version 1.0' to 'Version 2.0' etc.
Again, CDD will prepare a submission cover letter, as per the CDD HREC preferred standard format. Any specific Sponsor/CRO requirements for Submission Letters i.e. version number/date preferences etc, must be specified to the study coordinator at the time of submission, otherwise standard formatting will be used. Approval Letters will be issued according to the information provided in the Submission Letter. If this information differs to the Sponsor/CRO requirements, and was not communicated to the study coordinator prior to submission then changes to Approval Letter format will not be made retrospectively.
Administrative Changes
Submission must include:
- x16 copies of protocol
- x16 copies of the Patient Information and Consent form, if applicable
The CDD HREC will only provide Acknowledgment Letters when amendments to the protocol are Administrative Changes Only, i.e. if the changes have no effect on the patient's participation.
If an Administrative change affects the Patient Information and Consent form, then the preferred version number change would be for example from 'Version 2.0' to 'Version 2.1'.
Turn Around Time for Feedback and Approval
The CDD HREC generally is able to provide the Sponsor/CRO with an extract of the applicable section of Meeting Minutes, within 1 week of the meeting date. This extract will contain all requested amendments, or clarifications which need to be addressed before a decision will be made.
If approval is granted, the Approval Letter will be sent the next business day.
If the study is rejected, a Rejection letter with an explanation will be sent within 1 week of the meeting.
Serious Adverse Event Reporting
During the course of a study, the Sponsor/CRO is required to submit all Serious Adverse Event reports via the designated CDD study coordinator.
The CDD HREC does not send an acknowledgement letter for every SAE report received. SAE's submitted for all studies will be discussed at the next HREC Meeting. Unless there is concern over a particular SAE, the minutes will only document that SAEs for the relevant studies were discussed and no concerns were raised. An extract of these minutes can be supplied on request.
If concerns over an SAE are raised prior to, or during the meeting, the CDD HREC will communicate these concerns to the Sponsor/CRO immediately.
Completion / Termination of Study
At the completion, or termination, of a study, CDD is required to complete a Final Study Report and submit this to the CDD HREC. Sponsors/CROs are required to notify CDD when the study is completed at all sites (worldwide) and provide the necessary information. See link to template for details.
