CALVARY HEALTH CARE ADELAIDE – HUMAN RESEARCH AND ETHICS COMMITTEE
SAFETY SUMMARY EVENT REPORTING/ IB UPDATES
This form should be used to provide a summary of SUSARs or Investigator Brochure updates.
IB, Line listings or full Safety Reports should be attached to this Summary Report.
Protocol Title:Protocol No:
CHCA HREC Reference No:
Principal Investigator:
Type of document(tick the appropriate box)
Annual Safety Report date from: / / to: / /
OR
6 monthly SUSAR line listing date from: / / to: / /
OR
Investigator’s Brochure/Product Information version no: ______date: / /
Has the sponsor included a statement regarding the implications for participants and conduct of the study?
Yes No
(If No, please request from sponsor)
Action recommended by the Investigator/s
Change to the protocol/monitoring *Yes No
Change to the Participant Information and Consent Form/s * Yes No
Previously Enrolled Participants to be notified Yes No
Study to be suspended Yes No
Study to be stopped Yes No
No action Yes No
* If the report results in changes to the Protocol and/or PICF(s) please also submit the amended documents together a HREC Amendment Form requesting approval of these changes.
Declaration
I confirm that this project is being conducted in keeping with the conditions of approval of the reviewing HREC (and subject to any changes subsequently approved). I confirm that the project is being conducted in compliance with the NHMRC National Statement on Ethical Conduct in Human Research (NHMRC, 2007) or as amended. I confirm that I have not received any information in any form from anyone involved in the trial to suggest this report does not accurately reflect the progress of the project at the above site(s).
The Principal Investigator/Co-investigator has read and agrees that the above information is True.
______
Principal Investigator/Co-investigator Signature
HREC comment:Reviewed and acknowledged
Signature of HREC Chair/Delegate: ______
Date: / /
Notes
Annual safety information (non-sponsored trials): For trials involving an intervention or the administration of a non-approved medicine, the researcher must provide to the committee a detailed listing of serious adverse events as for SUSARS provided for sponsored trials. For non-interventional trials this information may be contained within the Annual Report.
Six Monthly Line Listings/SUSARs/IB:
As per the most recent Safety and Monitoring Guidelines published by the NHMRC in November 2016, researchers are not required to provide a six monthly listing of all SUSARS to CHCA HREC.
The line listings, annual safety reports and investigator brochures are reviewed by the Chairperson of HREC who may refer them to the full Committee if changes impact on issues relating to participants’ safety. If it is judged that the new information warrants further action the Chairperson will communicate this to the researcher and provide a timeline for any remedial action that may be required. Remedial action may be a change in procedures or information sheets, a requirement to notify participants or suspension of recruitment to the trial. Any action will be reviewed following a response from the researcher. The researcher is required to provide their own opinion in regard to potential impact on the need for further action and continuation of the trial using the CHCA HREC SAE Reporting of Summary Events-IB Updates form.
Changes to the Investigator Brochure: For sponsored trials, the committee requires an updated Investigator’s Brochure on an annual basis or more frequently where significant new findings related to the safety of the trial are discovered. The submission of the investigator’s brochure from the sponsor should contain a listing of changes and an indication whether the sponsor considers that the new information has impacted on the safety or ethical nature of the trial. The researcher must review the investigator’s brochure and form his/her own view of whether the new information has impacted on the safety or ethical nature of the trial and provide this information to the committee.
CHCA HREC SUSAR summary report/IB update template Page 1 of 2