An Urgent Amendment request is a prospective request to vary the protocol, usually for the benefit of a specific research participant, and must be adequately justified.
In almost all cases, the request is made due to the immediate needs of the research participant. Urgent Amendment Requests will be granted Interim Approval only when there are demonstrated safety concerns or other matters of urgency. Investigators new to the procedure are directed to consult with the Ethics Committee Secretariat or the study coordinator or research nurse.
Urgent Amendment requests usually fall into three categories:
- Request to treat outside the protocol requirements.
- Request to recruit outside the protocol eligibility requirements. In accordance with ICH-GCP, a request to recruit outside protocol eligibility requirements is only permitted if an amendment modifying the eligibility criteria is submitted within 30 days. Please note that although interim approval may be granted, once submitted the amendment will undergo full review at the next scheduled meeting of the Ethics Committee or subcommittee and any queries arising from the review will need to be addressed.
- Safety-related protocol changes affecting all trial participants. These requests should be submitted as a formal amendment. Please note that although interim approval may be granted the amendment will undergo full review at the next scheduled meeting of the Ethics Committee or subcommittee and any queries arising from the review will need to be addressed.
IMPORTANT NOTE: These requests must be submitted to the reviewing HREC for the project.
If Peter Mac Ethics Committee is the reviewing HREC submit as per the instructions in the sections below PREPARING/SUBMITTING YOUR URGENT AMENDMENT REQUEST.
Submission due dates
Submit at any time.
If an external Ethics Committee is the reviewing HREC for the project consult their requirements for urgent amendment submissions. Please notify the Peter Mac Research Governance Officer as advised below in URGENT AMENDMENT: GOVERNANCE NOTIFICATION.
Preparing your urgent amendment request
In order to obtain Interim Approval for an Urgent Amendment, the Principal Investigator must:
- Obtain approval for the proposed action from the project sponsor. If Peter Mac is the sponsor this approval should be obtained from the Sponsorship Committee. Please contact [email protected]
- Draft a Memo to the Ethics Committee including the Peter Mac Project Number, Project Title, participant study ID, and detailing the rationale for the urgent amendment and providing an explanation of the changes/variations. The memo must be signed by the CPI or site PI or their delegate
- Obtain approval for the proposed action, via signature of the Memo, from the Investigator’s department head or their delegate
- Obtain approval for the proposed action, via signature of the Memo, from the Chair of the Peter Mac Clinical Research Committee (CRC) or suitable delegate.
Submitting your urgent amendment request
- Email a scanned copy of your fully signed memo and the sponsor approval for the proposed action to [email protected] including the Project No. and the term ‘Urgent Amendment Request” in the subject line of the email.
The requested Urgent Amendment is considered approved upon receipt by the Ethics Committee Secretariat of the fully signed Memo and evidence of the sponsor approval and the requested action can proceed immediately.
Upon receipt of the fully signed memo and sponsor approval an Interim Approval memo will be issued. The interim approval will be ratified at the next scheduled Ethics Committee meeting and a ratification memo issued.
Urgent amendment: governance notification
The Research Governance Officer, Ethics Committee Secretariat must be notified of any urgent amendments that are approved by an external Ethics Committee for research participants at the Peter Mac site as follows:
- If Peter Mac Ethics Committee is not the reviewing HREC once the Ethical Approval has been issued by the external HREC the Urgent Amendment may then be conducted at Peter Mac. Email a copy of the request to the external reviewing HREC for the Urgent Amendment and the Approval issued by the reviewing HREC to [email protected] including the Project No. and the term ‘Urgent Amendment - Governance’ in the subject line of the email. If the external reviewing HREC requests any follow up or action to be taken also include a copy of these communications.
If the Research Governance Officer, Ethics Committee Secretariat has any queries regarding the notification they will communicate with the Principal Investigator. These notifications will not be acknowledged.