The Royal Melbourne Hospital Research Foundation

The Royal Melbourne Hospital Research Foundation

EASTERN HEALTH RESEARCH AND ETHICS COMMITTEE

PROGRESS REPORT FORM

Progress reports are required to be submitted to the Ethics Committee at least annually (National Statement on Ethical Conduct in Human Research (NHMRC, 2007).

  • Eastern Health Research and Ethics Committee approval of projects is on-going but will lapse if a satisfactory annual progress report is not received by the anniversary of project approval date.
  • All relevant sections must be completed otherwise the report will be considered invalid.
  • All researchers are required to complete Sections A, B, C and E.
  • Section D is required if the project is completed and a final report is being submitted.
  • Please e-mail a copy to and post a hard copy, SIGNED by the Principal Researcher to Eastern Health Research and Ethics, Level 2, 5 Arnold Street, Box Hill 3128.
  • A Final Progress Report must be submitted when study is completed.

PLEASE INDICATE: Annual Report Final Report

A. / PROJECT DETAILS
1. / Ethics Reference Number
2. / Project Title
3. / Project FINAL Approval Date
4. / Eastern Health Sites (eg. Box Hill Hospital)
5. / Principal Researcher/s
6. / Names of associated researchers
7. / Study Coordinator / Contact Person
- Name
- E-mail
- Phone
- Postal address
8. / Has there been any change to research personnel since project approval? / No
Yes If Yes, - has the Committee been notified?
Yes No - You need to notify the Committee using Change of Personnel Form..
B. / PROJECT SUMMARY
1. / Project Commencement Date (if study has not commenced please state reason and expected date of commencement)
2. / Project Estimated Completion Date
3. / Does the Project involve recruitment of participants? / Yes No , go to section C
Number of participants recruited at Eastern Health sites to date? (Examples:. 4 patients and 2 staff members at Box Hill Hospital; 1 patient at Maroondah Hospital, etc)
Recruitment completed? Yes No
Participant involvement completed? Yes No Provide details: (Eg. study treatment is continuing; follow up phase only.)
Number of participants withdrawn from the study?
Reason for withdrawal:
4. / Brief Summary of Project to date
C. / RESEARCH CONDUCT
1. / Amendments
Have there been amendments to the original protocol? / If Yes, please list the amendments
Amendment Version number and date / Ethics Approval Date
3. / Participants Information and Consent Forms (PICFs)
Not applicable: - do not fill in this section if study does not involve the use of a PICF) / Where are the signed originals of PICFs kept?
Have participants been given a copy of the signed PICF?
Yes
No If no, please provide details:
Version Number & date of the most current version / Ethics Approval Date
List below if more than one PICF is in use. Eg. Healthy Volunteer PICF, Optional Pharmacogenetic PICF, Person Responsible PICF, etc.)
Version Number & date of the most current version / Ethics Approval Date
4. / Maintenance and Security of Records
Are records maintained securely according to the NHMRC National Statement on Ethical Conduct in Human Research (2007)? / Yes
Details of where records are kept:
No
Reason for records not being kept securely:
5. / Conditions of Approval
Was final approval subject to certain conditions?
/ Yes No
If yes, please list conditions:
Have these conditions been met? Yes No
If not met, please provide details and reasons:
6. / Adverse Events
Have any local serious adverse events arisen during the course of this study? / Yes No
If yes, were these submitted to the ethics committee?
Yes
No
If not submitted, please state reasons:
How to submit safety notification:
7. / Ethical Issues
Have any unforeseen events occurred that might affect continued ethical acceptability of the project? / Yes
If yes please give details:
No
8. / Insurance
If the study has commercial sponsorship, is the insurance certificate current? / Yes - Please attach a current insurance certificate
No - Please request an insurance certificate as soon as possible
No Commercial Sponsorship
9. / Auditing
Has the project been subject to an external audit during the year? / Yes No
If yes, date of audit:
Please attach a copy of audit report/letter.
Other comments:
D. / FINAL REPORT / Not applicable:
Please complete this section if your project meets the following criteria:
- The results have been published or presented.
- Data analysis is complete and a lay summary of findings is available and included.
- A close out visit has taken place (for an externally sponsored trial).
1. / Date the project was completed
2. / Summary of findings / (Attach separate document if preferred, no more than 500 words. Summary should be in lay language.)
3. / Total number of participants recruited
4. / Details of any presentations, publications accepted or in press / (Attach abstracts.)
If there is no plans for publication, please give reason:
5. / Do you think there should be any changes in practices at Eastern Health as a result of this project?
6. / Where are the records being kept or archived?
E. / DECLARATION – the section must be completed.
1. / I confirm that this project is being conducted/has been conducted as originally approved by the Eastern Health Research & Ethics Committee (and subject to any changes subsequently approved) and that the study is conducted according to the NHMRC National Statement on Ethical Conduct in Human Research (2007).
Signature of Principal Researcher/s: Date:
Signature of Principal Researcher/s: Date:
Signature of Student Researcher/s: Date:
(For Student projects, signatures are also required from the Supervisor/s.)
PLEASE NOW SUBMIT AN ELECTRONIC COPY AND A SIGNED HARD COPY.
Other comments:

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