Research Governance fees
Research Governance authorisation for clinical trials will not be granted without a completed invoicing authorisation form. This form must accompany every new clinical trial submission and amendment presented to the Research Governance Office.
Please contact the Research Governance Office if you are unsure of whether a fee is applicable to your application.
| Clinical trial application | Institution-sponsored clinical trials | Non-commercial external sponsor (GST exclusive) | Commercial external sponsor (GST exclusive) |
|---|---|---|---|
| Initial site specific application review | $0 | $1,000.00 | $4,500.00 |
| Non-standard contract review | see section 4.6 of PD | $500.00 | $2,000.00 |
| Amendment – major amendment* (Clinical trial only) | $0 | $250.00 | $750.00 |
| Amendment – minor amendment** (Clinical trial only) | $0 | $100.00 | $325.00 |
*Major amendment
- Protocol 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).
**Minor amendment
- 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
Please note that at SCHN, an amendment that involves both major and minor changes will only incur a major amendment fee.
Clinical trial fees are mandated by the NSW Ministry of Health Policy Directive (PD).
Frequently asked questions
What is an invoice authorisation form?
The invoicing authorisation form is a document that SCHN Research Governance uses to process payments relating to research projects.
Does my Research Governance application/amendment need an invoice authorisation form?
An invoice authorisation form is only required if the research project is a clinical trial. Please refer to the below link for specific details:
What is a Major and Minor Amendment?
Please refer to Policy Directive by NSW Ministry of Health for further information:
Please note, at SCHN, an amendment that involves both major and minor changes will only incur a major amendment fee.
What is a standard contract?
Please refer to research agreements in NSW health organisations.
For further information regarding Standard Contracts please contact the SCHN Research Governance Office via email if you are unsure or need further information.
A CTRA is considered a standard contract, why do amendments to the CTRA require an invoice authorisation form?
An amendment to the CTRA is considered a major amendment, thus will incur a major amendment fee for Research Governance review.
Please contact the SCHN Research Governance Office via email for further information.