Introduction
Due to an increase in multi-centre international studies, large volumes of safety reports are being generated from around the world. The following submission guidelines clarify current requirements in relation to reporting to the Eastern Health Research and Ethics Committee.
These guidelines apply to the reporting of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs) and other safety notifications to the Eastern Health Research and Ethics Committee.
General Principles:
- All safety reports must be reviewed by the investigator.
(ii) The investigator should determine the relevance of the information to study conduct and provide a comment to this effect in all submissions.
(iii) Report within 15 days any changes that may:
- Increase risk for participants
- Affect the safety or health of participants
- Affect trial conduct
(iv) Report any new informationthat may:
- Impact on the ethical acceptability of the trial
- Result in a change in protocol
- Alter safety monitoring
(v) Individual reports should not be submitted without contextual information.
LOCAL Eastern Health Serious Adverse Events (SAEs)
- Report within 24 hours of first knowledge
- Initial notification may be done via e-mail: ethics@easternhealth.org.au and must include:
- Name of the event
- Assessment of causality
- Date event occurred
- Ethics reference number
- Eastern Health site eg. Box Hill Hospital
- A paper submission must follow using an EH local SAE notification form with the following inclusion:
- A brief summary of the event eg. whether SAE is a pre-existing condition, if participants continue on study medication and the event outcome.
- The Principal Researcher should provide a comment and sign the form.
- The event will be reported to the Victorian Managed Insurance Authority (VMIA) as required and presented to the Sub-Committee/Committee. An acknowledgement will be provided on the same form submitted.
NON-EASTERN HEALTH safety reports (eg. multi-centre clinical trials):
(I) Other Australian sites - Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Submit monthly on a safety reporting form.
- Attach individual reports.
- The Principal Researcher should provide a comment and sign the safety reporting form.
- An acknowledgement will be provided on the same form submitted.
- Forward any subsequent recommendation from the Therapeutic Goods Administration.
(II) Global sites - Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Submit on a safety reporting form.
- Quarterly to 6 monthly listings should be provided by the Sponsor for ethics submission.
- If no quarterly listings or summaries have been provided by the Sponsor individual events should be listed on the safety reporting form for submission.
- Individual safety reports do not need to be attached but should be available on request.
- The Principal Researcher should provide a comment and sign the safety reporting form.
- An acknowledgement will be provided on the same form submitted.
(III) Global (including other Australian sites) - Serious Adverse Events (SAEs)
- Submit on a safety reporting form.
- Annual global SAE listings should be provided by the Sponsor for ethics submission.
- Do not attach individual reports.
- The Principal Researcher should provide a comment and sign the form.
- An acknowledgement will be provided on the same form submitted.
(IV) Other safety correspondences: eg. Data Safety Monitoring Board (DSMB) memos
- Report these promptly.
- Use the safety reporting form for submissions. Do not submit these using individual cover letters.
- The Principal Researcher should provide a comment and sign the form.
- An acknowledgement will be provided on the same form submitted.
Submission for more than one study
There are occasions where safety reports meet the regulatory requirements for more than one study. This should be clearly stated. Full study titles and ethics reference numbers should be included in the form.
Liaison between Sites
Where existing trials are running at more than one Eastern Health site, researchers must collaborate when submitting SAE’s where appropriate.
Definitions:
Adverse event: any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Comment: An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product, whether or not considered related to the investigational medicinal product.
Adverse reaction: all untoward and unintended responses to an investigational medicinal product related to any dose administered.
Comment:All adverse events judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product qualify as adverse reactions. The expression reasonable causal relationship means to convey in general that there is evidence or argument to suggest a causal relationship.
Unexpected adverse reaction: an adverse reaction, the nature, or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product).
Comments: When the outcome of the adverse reaction is not consistent with the applicable product information this adverse reaction should be considered as unexpected.
Severity: The term “severe” is often used to describe the intensity (severity) of a specific event. This is not the same as “serious,” which is based on patient/event outcome or action criteria.
Serious adverse event or serious adverse reaction: any untoward medical occurrence or effect that at any dose:
- Results in death,
- Is life-threatening
- Requires hospitalisation or prolongation of existing inpatients hospitalisation,
- Results in persistent or significant disability or incapacity,
- Is a congenital anomaly or birth defect.
Comments:
- Life-threatening in the definition of a serious adverse event or serious adverse reaction refers to an event in which the subject was at risk of death at the time of event; it does not refer to an event which hypothetically might have caused death if it were more severe.
- Medical judgement should be exercised in deciding whether an adverse event/reaction is serious in other situations. Important adverse events/ reactions that are not immediately life-threatening or do not result in death or hospitalisation but may jeopardise the subject or may require intervention to prevent one of the other outcomes listed in the definition above, should also be considered serious.
Further reading:
- The Australian Clinical Trial Handbook, A simple practical guide to the conduct of clinical trials to International standards of Good Clinical Practice (GCP) in the Australian context March 2006 (http://www.tga.gov.au/ct/cthandbook.pdf)
|
Eastern Health Research & Ethics Committee
