Post Ethics Approval

When the HREC is satisfied with the ethical aspects of a research proposal it will issue a written approval to the (Co-ordinating) Principal Investigator.

1.HREC ANNUAL REPORTS 
It is a requirement of the NHMRC that reports on the progress of all approved studies must be submitted to the Committee at least annually. Reports must include a statement that the study is being/has been undertaken according to the original application (or as amended) and that all data is securely stored.

• Annual progress reports on multicentre studies must include information on the status of the study at all NSW sites for which the Ethics Review Committee is providing ethical oversight. It is the responsibility of the Co-ordinating Investigator to compile this data from advice provided by the site Principal Investigators.
• For clinical trials of drugs or devices being done under the CTN Scheme with SLHD sponsorship, the Committee requires quarterly reporting.
•For all other studies (including clinical trials sponsored by commercial companies), the Committee requires annual reporting.
•For the convenience of investigators, reminder letters and standard report forms are forwarded to the Chief Investigator approximately two weeks before each report is due.
•A final report must be submitted when the study has been completed and the results known. Please note that the Committee does not consider a study complete until the data are analysed and a report of the results written and placed in the public domain.

Ethics approval is for a period of five years subject to the receipt of satisfactory annual reports. The Research Office will send a reminder. 

If the study continues beyond five years then a resubmission request will need to be made and you may need to submit a new ethics application form.

2. RESPONSIBILITIES OF INVESTIGATORS
The HREC requires, as a condition of approval, that Investigators immediately report anything which might warrant a review of the ethical approval of a study. For example:
• Proposed changes in the research protocol or conduct;
• Unforseen events that might affect the continued ethical acceptability of the project;
• Serious or unexpected adverse events (report to their local Research Governance Officer);
• The study is abandoned for any reason. 

3. AMENDMENTS
An application for an amendment should be made through REGIS. The form will require you to include the following:
• The study’s protocol number and title
• Information on the reason why the amendment is needed
• The nature of the amendment
• The revised Protocol in track change with a new version # and date
• If applicable: The revised Participant Information Sheet & Consent Form in track change with a new version # and date
• If applicable, for clinical trials: All updated Investigator's Brochures must be submitted via REGIS.

4. ADVERSE EVENTS IN CLINICAL TRIALS

Check out our Safety Monitoring page.

5. PROTOCOL NON-COMPLIANCE

Protocol deviations / violations

A Protocol ‘deviation’ or ‘violation’ is any breach, divergence or departure from the requirements of Good Clinical Practice (GCP) or a study protocol. Protocol deviations/violations can be minor or major. A minor deviation/violation has low/minimal impact

GCP requires all deviations to be reported to and collated by the sponsor so that corrective and preventative action can be implemented and so that their impact on the analysis of the data can be considered when the clinical study report is produced.

The Principal Investigator should perform a risk assessment to determine the severity and impact and whether the deviation/violation constitutes a serious breach.

Serious Breaches

Serious breaches should be reported in accordance with NHMRC Guidance document: Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods 2018. The NHMRC guidance does not use the terms Protocol Deviation or Protocol Violation.A serious breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree:
• The safety or rights of a trial participant, or
• The reliability and robustness of the data generated in a clinical trial.

Serious breaches should be reported to the reviewing HREC, usually by the Sponsor, within 7 calendar days of confirming a serious breach has occurred. The HREC will review the serious breach to evaluate its impact on the continued ethical acceptability of the study and to satisfy itself that the serious breach is managed appropriately.

It is the responsibility of the Principal Investigator to (i) report any suspected breach to the sponsor within 72 hours of becoming aware of it and (ii) to report to their institution (via the Research Governance Officer) within 72 hours any serious breach that has been confirmed by the sponsor as occurring at their site.

Reporting Responsibilities

SLHD-sponsored clinical trials

Where SLHD has agreed to sponsor an investigator-initiated clinical trial, the Coordinating Principal Investigator / Principal Investigator (at SLHD) must take on sponsor reporting responsibilities.

The Principal Investigator must document all protocol deviations/violations and submit a report to the SLHD HREC and RGO with their annual or quarterly (RPAH) report. The Principal Investigator should perform a risk assessment to determine the severity and impact and whether the deviation/violation constitutes a serious breach. If a serious breach has been determined, the Principal Investigator must report it to the HREC and TGA per the reporting timeframes above. A Corrective and Preventive Action (CAPA) plan should be submitted with the report.  

SLHD researchers are recommended to use the following resources to monitor their trials and conduct self-assessments:

·         Corrective and Preventive Action (CAPA) form

·         SLHD Audit Preparation Tool

·         SLHD Audit-Ready training