FAQs for Invoices
FREQUENTLY ASKED QUESTIONS - Fees for Research Ethics and Governance Review of Clinical Trial Research
This information is in accordance with the NSW Health Information Bulletin ‘Fees for Research Ethics and Governance Review of Clinical Trial Research’ () and the NSW Health Policy Directive Fee Schedule for Research Ethics and Governance Review of Clinical Trial Research (PD2023_015)
1. 1. When should invoice details be submitted?
The study team must provide appropriate invoicing details when submitting their research applications and/or amendments. The sponsor, principal investigator and/or relevant research project contact person is responsible for ensuring the invoice is paid in accordance with details included.
2. 2. How do I submit the invoice details?
Please contact the research office on the details listed below to obtain a link to submit the invoice details securely via REDCap.
3. What is considered a major amendment?
A major amendment is considered more than an administrative change and, in the case of an amendment submitted for Research Ethics Review under Table 1 above, a full review by a Human Research Ethics Committee is required. Examples of major amendments include:
· protocol amendment
· contract amendment
· revision of the study design due to safety issues
· revisions in drug dosage, participant groups and numbers of study participants
· investigator brochure updates, where there are associated changes required to the Participant Information Sheet/ Consent Form (PISCF).
4. What is considered a minor amendment?
A minor amendment is defined as changes to the details of a research project that have no significant implications for the safety of participants or for the conduct, management, or scientific value of the research project. Examples of minor amendments include:
· Participant Information Sheet/ Consent Form amendments with changes not required to be reviewed by the Human Research Ethics Committee.
· Investigator brochure updates where there is no change required to the Participant Information Sheet/ Consent Form.
· Change of Principal Investigator/ Coordinating Principal Investigator.
· Minor updates to existing patient-facing documents, protocol clarification letters, advertising material and single-word changes.
5. What is the fee for adding an additional site?
A fee for an additional site is to be charged when a clinical trial adds a site to a clinical trial study after Human Research Ethics Committee approval has been granted. The fee will be charged for each site being added.
6. What are the fees for Non-Standard Contracts
While no fee may be charged for the presence of a non-standard contract for an institution-sponsored clinical trial, if a review of that contract by an external legal provider is required, research support offices may pass that cost on to the study team/ funder. This includes where an investigator-initiated clinical trial requires a ‘contract for support’ that is entered into with a funder or a provider of study product.
6. Who do I contact if I require assistance?
Research Office (Concord Repatriation General Hospital)
Phone: 02 9767 6233