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| VMIA Guidelines for clinical trials | CTRA for non-investigator-initiated trials |
| Other CTRA | Injury compensation guidelines | Form of indemnity | CTN Scheme Form |

Commercially sponsored applications are usually accompanied by an indemnity statement, an insurance certificate and a clinical trial agreement. However, agreements are also usually provided for other types of studies.

The Alfred Hospital insurers and lawyers have certain requirements regarding the wording of these documents and applicants and commercial sponsors should be familiar with these. The relevant documents are listed below.

VMIA guidelines for clinical trials

Clinical Trial Research Agreements for non-investigator-initiated trials

Drug Trials
Our insurer, VMIA, has provided us with new, interim guidelines regarding Clinical Trial Research Agreements (CTRAs), formerly called Clinical Trial Agreements (CTAs). These guidelines affect the following three Medicines Australia / VMIA CTRA templates:

The CTRA to be used depends solely upon the type of organisation listed as the sponsor in the CTN form and thus, the organisation providing the Medicines Australia Form of Indemnity for Clinical Trials as well. Therefore, if the sponsor in the CTN form is a commercial sponsor, the CTRA for Commercially Sponsored Trials is to be used, whereas if the sponsor on the CTN is a CRO, the CTRA for CROs is to be utilised. If the sponsor on the CTN form is a commercial sponsor, we cannot enter into an agreement with a CRO.

In regards to the commercially sponsored trials, although VMIA encourage us to enter into agreements with the local Australian sponsor as required by the new guideline, we can enter into agreements with international sponsors.

In some instances, the international sponsor may request that both they and the local sponsor be listed in the agreement. This is possible with the use of VMIA-approved wording to be included in Schedule 7 of the CTRA. However, the institution will only have obligations to the local Australian sponsor. Please contact the Ethics Office if the sponsor does not have the VMIA-approved wording and it will be provided.

Please remember, there are to be no changes made to the body of the CTRA. All changes should be clearly detailed in Schedule 7. Many of the sponsors have submitted their Schedule 7 wording to VMIA who have, in collaboration with NSW Health, reviewed and issued us with all of the approved wording. Any other wording will need to be reviewed by Alfred Health which will incur a fee of at least $1,000 plus GST depending on the amount of work involved.

Checklist

In order to expedite the signing of the CTRA and indemnity, a checklist has been developed which researchers can use to check the CTRA before it is submitted to the Ethics Office. If the checklist highlights any of the details as incorrect, please inform the sponsor and request corrected copies.

Device Trials
A CTRA for trials involving devices has been developed by the Medical Technology Association of Australia (MTAA), the VMIA, NSW Health and QLD Health. The Clinical Investigation Research Agreement (CIRA) is to be used by Victorian Public hospitals when they are engaged by a device company to conduct a human trial involving their product. This Agreement has been developed specifically to address the requirements that attach to a device trial which otherwise could not be accommodated for via the other CTRAs currently in place. The CIRA has adopted the same format as per existing CTRAs, bar for industry specific nomenclature.

THE CIRA is to be used in conjunction with the MTAA Standard Indemnity Form for a Clinical Investigation. There is also the MTAA Standard Indemnity Form for a Clinical Investigation for HREC review only.  These indemnities also have specific MTAA Compensation Guidelines.

There will also be specific “Compensation” wording in the Participant Information & Consent Form (PICF) for device trials.  The wording will be available in the PICF template shortly.

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Other Clinical Trial Research Agreements

Clinical Trial Preparation Agreement ("Pre-Nup")
This can be used to cover the start-up fee and should be signed before or during the ethics review, before the main CTRA is executed.

Investigator-initiated, company supported trials
Investigator-initiated trials should fulfill the following VMIA criteria for an investigator-initiated trial:

  • The principal investigator or the Hospital/Institution is the primary author and custodian of the clinical trial protocol
  • A pharmaceutical/device company is not acting as the sponsor for the purposes of the CTN application
  • The clinical trial addresses relevant clinical questions and not industry needs

CTRA for investigator initiated studies - Alfred Health (MS Word)

Monash University studies conducted at Alfred Health
The following template, developed by the VMIA, is to be used for studies devised by University but involving Alfred Health in the conduct of the trial.

Investigator-initiated, multi-centre trials
The following template, developed by the VMIA, is to be used when an Alfred Health, investigator-initiated trial is being conducted at several sites.

Please notify the Ethics Committee of any new sites not included in the original ethics application or any subsequent amendment applications, particularly overseas sites as there may be insurance issues.

Amendments or Addenda to CTRAs
If a CTRA has already been signed and needs to be revised, for example to incorporate additional funding to be provided, the appropriate way to incorporate these changes is to sign an amendment or addendum to the CTRA.

Checklist

In order to expedite the signing of Amendments to the CTRA, a checklist has been developed which researchers can use to check the amendments or addenda before they are submitted to the Ethics Office. If the checklist highlights any of the details as incorrect, please amend and provide corrected copies.

Number of copies of legal documents
Alfred Health lawyers have recommended that the number of copies should correlate with the number of parties. Therefore, only two indemnities and usually two or three CTRAs should be submitted for signing. All other required copies should be photocopies.

Guidelines for compensation for injury resulting from participation in a company-sponsored clinical trial

Form of indemnity for clinical trials

Checklist

The following checklist may be useful when reviewing indemnities. If the checklist highlights any of the details as incorrect, please inform the sponsor and request corrected copies.

Clinical Trial Notification (CTN) Scheme Form

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This page was last modified on 06/01/12


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