Annual Project Progress Report (PPR)

and Extension Request

Under the terms of the National Statement on Ethical Conduct in Human Research 2007 (NS), researchers are required to submit an annual report on the progress of current trials/studies.

ACT Health Human Research Ethics Committee requires a progress report to be submitted at least annually.

To assist you with this requirement, please complete the following:

Project Title:
Principal Investigator:
ACTH-HREC reference number: ETH.
Date of Approval: / dd/mm/yyyy
Reporting Period / yyyy - yyyy
Date:

Section 1: Status of Study

Is this a final report? / Yes/No
If yes, please complete the Final Report template

Annual Project Progress Report

Section 2: Summary of Progress (NS5.5.5(a))

Summarise study progress over the last 12 months or since the last progress report date
· 

Section 3: Participants and Consent

Have participants been recruited during the reporting period? / Yes/No/NA
If yes, how many?
Have the approved consent procedures been followed? / Yes/No/NA
If no, have the breaches been previously reported? / Yes/No
Comments
· 

Section 4: Compliance (NS5.5.5 (c) and (d))

Has the project been conducted according to the approved proposal or protocol / Yes/No
Has the project been conducted according to the conditions of ethical approval / Yes/No

Section 5: Privacy and Data Security (NS5.5.5(b))

Have the approved confidentiality and data security procedures been followed? / Yes/No
If not, give details
· 

Request for Extension of Ethical Approval Period

Note: an extension may be requested up to 12 months ahead of the expiry date of the current approval period. Late extension requests will not be applied retrospectively. Approval will be granted from the date of HREC meeting.

Section 6: Extension of Ethical Approval

Is an extension of approval required? / Yes/No / 1yr - 2yrs - 3yrs - 4yrs - 5yrs
Briefly describe reasons for extension:
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Section 7: Reporting – All Projects

Has all reporting been completed and submitted to the HREC as follows:
Address each item and where compliance has not been maintained, please include an explanation
Annual Project Progress Report / Yes/No
Amendments to the study proposal or protocol / Yes/No
Amendments to the participant information and consent forms (PICF) / Yes/No
Changes of investigator or other personnel / Yes/No
Any events that may affect the continued ethical acceptability of the study / Yes/No
Comments
· 

Reporting – As Applicable

Has all reporting been completed and submitted to the HREC as follows:
Address each item and where compliance has not been maintained, please include an explanation
SUSAR/Line listing – if applicable / Yes/No
Data safety and monitoring board (DSMB) reports / Yes/No
Serious Adverse Event (SAE) reports / Yes/No
Changes in clinical practice that may affect the study / Yes/No
Comments
· 

Investigator Declaration

I confirm the above details are true and correct

Signature: / Date:

Please return the completed report via email to .a

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