NORTH METROPOLITAN AREA MENTAL HEALTH SERVICE

RESEARCH ETHICS & GOVERNANCE OFFICE

ANNUAL/FINAL REPORT

(please select one)

Site Investigator:
Mailing Address:
Telephone: / Email Address:
REGO PROJECT No
PROJECT TITLE
APPROVED TO:

This project has approval to the date shown above. If you require an extension please apply in writing.

NOTE: YOUR PROGRESS REPORT IS DUE TWO WEEKS FROM THE DATE OF THIS REQUEST

When answering the questions please tick the appropriate response.

1 / The original expected commencement date was:
2 / The original expected completion date was:
3 / The actual commencement date was:
4 / If complete, the actual completion date was:
5 / Has work on the project been carried out during the past twelve months? / YES / NO
If NO please detail the reasons why in your progress report
If your study involves access to archival tissue or access to records only (no participants required) go to question 14
6 / How many participants will be recruited for this study?
7 / How many participants have been recruited for this study to date?
8 / When do you anticipate recruitment to cease?
9. / Have any participants withdrawn or been asked to withdraw from this study? / YES / NO
If YES please provide details in your attached progress report
10 / Have there been any unfavourable comments from participants concerning the
conduct of this study?If YES please provide details in your attached progress report / YES / NO
11 / Have there been any adverse events experienced by the participants? / YES / NO
If YES please provide details in your attached progress report
12 / Has any investigator, co-investigator, data manager or other employee left or joined
the project in the last twelve months? / YES / NO
If YES please provide details in your attached progress report
13 / Is there any information about the project, which was not available to the HREC when the protocol was approved including changes to the information sheet or consent form?
If YES please provide details in your attached progress report / YES / NO
14 / Has the research been published/presented? / YES / NO
If YES please provide details in your attached progress report

Please attach the progress report (no more than one page) on the past twelve months. Include details if there has been any

  • compliance with the consent procedures and documentation
  • unforeseen events that have occurred
  • proposed changes in the protocol that might affect continued ethical acceptability of the project
  • departure from the approved requirements on maintenance and security of records

Please Note: This report is required to be tabled at a HREC meeting and any annual or final reports submitted without a progress report will be immediately returned to the investigator.

Please sign and date below and return to - Executive Officer, Research Ethics & Governance Office, Gascoyne House, GraylandsHospital, Private Bag No. 1, Claremont, WA 6910
Name
(please print):
Signed: / Date:
REGISTRATION DETAILS
If it has not already been provided please include registration number andthe trial registry that the project is registered with.
Clinical Trials Registry:
Number:

**** Please DO NOT use this annual report form to submit your requests for amendments/changes to your project. Please address these requests to the REGO in a formal letter.

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Annual_Final Report 2012.doc