Reporting

Safety Reporting

The safety reporting process to the CRGH RGO is as follows:  

Research Governance Officers (RGO) will receive: All significant safety issues (SSIs), any local SUSARs/ Unanticipated Serious Adverse Device Effects (USADEs)/ Unexpected and Related Serious Adverse Event (URSAEs) arising from the site and any research-related events that meet the definition of an incident. These will be submitted via REGIS by the investigator to the local RGO. To access the quick reference guide for Safety Reporting in REGIS, please click on the link below.

 
https://regis.health.nsw.gov.au/media/1725/qrg-resapp-clinical-trial-safety-reporting.pdf

SSI occurring within the CRGH zone: For all clinical trials:

(i) Submit SSI notification to the Research Governance Officer within 72 hours.  (i.e. no need to submit to HREC) including Urgent Safety Measures (USM).

(ii) For drug trials: Any suspected (related) unexpected serious adverse reaction (SUSAR) involving a SLHD Hospital research participant.

(iii) For device trials: Any unanticipated serious adverse device effect (USADE) involving a SLHD Hospital research participant.

(iv) For non-therapeutic goods trials (eg surgical trial): Any unexpected and related serious adverse event (URSAE) involving a SLHD Hospital research participant.

You are not required to submit Quarterly or 6 monthly SUSAR line-listings to the RGO.

SAE occurring at site outside the SLHD zone: Do not submit to RGO unless the event is considered possibly, probably or definitely related to the study conduct and the SAE had an effect on the conduct of the study (requiring any or all of the following):

1.     Protocol changes

2.     Investigator Brochure changes

3.     Participant Information Sheet changes

For clinical trials: 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.

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.

The NHMRC guidance does not use the term Protocol Violation.

It is the responsibility of the SLHD Principal Investigator to:

1) Report any suspected breach to the sponsor within 72 hours of becoming aware

of it.

2) Report to the SLHD RGO within 72 hours any serious breach that has been confirmed by the sponsor as occurring at CRGH.

Serious breaches should be reported to the HREC, usually by the Sponsor, within 7 calendar days of confirming a serious breach has occurred.

There is no requirement to submit an Updated Investigator’s Brochure or Annual Safety Report to the RGO. 

Protocol Deviations/Violations

A Protocol Deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the HREC. 

A Protocol Violation is any change, divergence, or departure from the study design or procedures of a research protocol that affects the participant's rights, safety, or well-being and/or the completeness, accuracy and reliability of the study data. 

1. Minor protocol deviations: If these do not carry significant ethical / administrative implications or consequences they do not need to be reported to the HREC.

    However, please record all such deviations in the study file and report them to the sponsor.

1. Major deviations and protocol violations: If these pose a risk to patient safety, or have ethical or significant administrative implications they must be reported to the HREC and the Sponsor as soon as possible.

Annual Reporting (Milestones) should be submitted via REGIS

When Ethics is in REGIS, a governance milestone is not created for a progress report. When approved/achieved by Ethics, it is shared with each site in REGIS and if the RGO requires further information, the PI will be notified. 

External HREC: Where Ethics is outside of REIGS and is being managed in another jurisdiction, the HREC approved annual progress reports must be submitted to the sites as a Milestone in REGIS.

Quick Reference Guide link below:

https://regis.health.nsw.gov.au/media/1730/qrg-resapp-submitting-governance-milestones.pdf