The submission of an annual progress report, or a final report in the case of completed research, is a condition of ethics and governance approval.

Responsibilities of investigators with regard to monitoring and reporting on approved research are outlined in:

• National Statement on Ethical Conduct of Human Research – Section 5.5.5  and;
•  ICH-GCP Note for Guidance on Good Clinical Practice – section 4.10 

 

Ethics

The HREC is required to monitor approved research projects to ensure compliance with the conditions of approval and to protect the rights, safety and welfare of participants. This includes review of annual progress reports and final reports.

In Regis these reports are processed through milestones. As the Co-ordinating Principal Investigator (CPI) has overall responsibility of the study, they are required to submit the milestone to the reviewing HREC.

The first milestone report is to be submitted 12 months from the original date of ethical approval. A reminder will be sent from Regis if no report is received after 30 calendar days.

Guidance on how to submit a milestone report can be found on the Regis QRG page  under Ethics: Post-Approval.

 

Governance

Research Governance Officers maintain an oversight of authorized research projects through review of milestones submitted by the Principal Investigator, including any recommendations made by HREC following the review of progress/final reports.

The following governance milestones are required to be submitted via REGIS:

• First Patient In
• Certificate of Currency
• Progress Report – HREC External to NSW/ACT (When ethics application is managed outside of REGIS)

Guidance on how to submit the above milestone reports in REGIS can be found  here .
 

Progress/Final Report, when ethics application is managed within REGIS:

Once the HREC has reviewed and noted the progress/final report, it will be automatically provided to each authorised site listed in REGIS (see Project Details, HREC approved sites, table 1), no additional submission is required for governance review of progress/final report for the NSLHD site(s) authorized in REGIS. NSLHD RGO will only contact the Principal Investigator if they require more information.

 

Progress/Final Report, when ethics application is managed outside REGIS:

Once the HREC has reviewed and noted the progress/final report, please contact the Research Office and request a milestone report be created to allow for submission of the report.