| VMIA Guidelines for clinical
trials | CTRA for
non-investigator-initiated trials |
| Other CTRA
| Injury compensation guidelines |
Form of indemnity | CTN
Scheme Form |
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.
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.
guidelines for clinical trials
Trial Research Agreements for non-investigator-initiated 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
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.
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.
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.
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.
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.
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.
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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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.
company supported trials
Investigator-initiated trials should fulfill the following
VMIA criteria for an investigator-initiated trial:
principal investigator or the Hospital/Institution is the primary author
and custodian of the clinical trial protocol
pharmaceutical/device company is not acting as the sponsor for the
purposes of the CTN application
clinical trial addresses relevant clinical questions and not industry
CTRA for investigator initiated studies - Alfred Health (MS Word)
University studies conducted at Alfred Health
The following template,
developed by the VMIA, is to be used for studies devised by
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
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.
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
of indemnity for clinical trials
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
Clinical Trial Notification (CTN) Scheme Form