This applies where a research project is being conducted at Eastern Health but the application is being reviewed and approved by another Human Research and Ethics Committee.
You are required to submit a Site Specific Assessment or SSA for a new project.
Use a ‘Research Governance Checklist for Principal Investigators’ – available from the Consultative Council for Clinical Trial Research web-site.
Information and instructions from Consultative Council for Clinical Trial Research web-site is relevant to your submission.
Submit the following documents.
| Documents | Hard Copy | Electronic File |
| Research Governance Checklist for Principal Investigators | Yes | Yes |
| Cover Letter – signed by Principal Investigator |
Yes | Yes – PDF file with signatures |
| Application Fee | No
(unless payment is by cheque) |
Yes |
| Site Specific Assessment Form | Yes – fully signed | Yes – PDF file with signatures |
| Victorian Specific Module (VSM) | No | Yes – with signatures |
| Use of Ionising Radiation
– Section 4 of Victorian Specific Module |
No | Yes – PDF file with signatures |
| Medical Physicist Report | No | Yes – PDF file with signatures |
| Study Protocol | Yes | Yes |
| Investigator Drug Brochure | No | Yes |
| Human Research Ethics Committee Approval correspondence | No | Yes |
| Full set of the documents as approved by the Reviewing Human Research and Ethics Committee | No
(except for Protocol, as in item 6 above) |
Yes |
| Eastern Health specific documents, eg Participant Information and Consent Forms.
EH PICF Must have:
|
No | Yes |
| Clinical Trial Research Agreements | Yes | No
Must use approved templates |
| Indemnity Forms
Must use approved templates. Download from Medicines Australia web-site. |
Yes
Submit minimum of two original documents, signed by the external Sponsor. Eastern Health will retain one fully signed original after final sign off. |
No |
| Evidence of Current Insurance
Insurance must adhere to hospital insurer’s guidelines. See Victorian Managed Insurance Authority (VMIA) web-site. |
No | Yes |
| Clinical Trial Notification Form
Download form from Therapeutic Goods Administration (TGA) website. |
Yes
Submit original CTN form. Submit one original for each site, signed by the Principal Investigator and the reviewing Human Research and Ethics Committee. |
|
| Curriculum Vitae
Applies to researchers who have not submitted a CV in the last two years. CV should be one to two pages only, to include:
Do NOT include an extensive publications list. |
No | Yes |
(1)
Submit the following documents only AFTER APPROVAL by the reviewing Human Research and Ethics Committee (HREC).
| Documents | Hard Copy | Electronic File |
| Application Fee as per fee schedule | No
Unless payment is by cheque |
Yes |
| HREC approval correspondence | No | Yes |
| Protocol amendment | No | Yes |
| Investigator Drug Brochure | No | Yes |
| Administrative Letter | No | Yes |
| Master Participant Information and Consent Form (PICF) | No | Yes |
| Safety Notification – Global, non-Eastern Health specific, including data monitoring committee memos | No | Yes |
Other documents, eg
|
No | Yes |
| Eastern Health specific documents, eg PICF
EH PICF Must have:
|
No | Yes |
(2)
Submit the following documents DIRECTLY to Eastern Health
| Documents | Hard Copy | Electronic File |
Eastern Health local Serious Adverse Event (SAE)
1. A summary of the event eg. whether SAE is a pre-existing condition, if participants continue on study medication and the event outcome. 2. Confirmation of whether the SAE is a suspect unexpected serious adverse reaction (SUSAR). 3. A comment on the impact of the SAE on study conduct and signature by the Principal Investigator.
|
No | Yes – PDF file with signatures |
| Eastern Health Site Specific Progress Reports – annual and final
A progress report must be submitted annually. Submit using the Progress Report. Include information on progress to date, maintenance and security of records, compliance with approved protocol, compliance with conditions of approval, and insurance status (for commercial projects). Ongoing authorization of project is subject to the submission of a satisfactory project report. A final progress report is required when the project is completed. Submit when one the following has occurred:
Use the same Eastern Health Progress Report Form, checking the box for ‘final’ report. |
No | Yes – PDF file with signatures |
Clinical Trial Research Agreement addendum or amendment
|
Yes | No |
| Updated insurance certificates
In accordance with Victorian Managed Insurance Authority (VMIA) guidelines.
|
No | Yes |