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The Alfred Research & Ethics Unit |
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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
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.
Checklist for non-investigator-initiated trials (MS Word) 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.
Clinical Investigation Research Agreement (CIRA) 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. MTAA
Standard Indemnity Form for a Clinical Investigation There
will also be specific “Compensation” wording in the Participant [ ^ ] Other Clinical Trial Research Agreements
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
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 Monash University but involving Alfred Health in the conduct of the trial.
VMIA CTRA for an investigator initiated study (MS Word)
Investigator-initiated, multi-centre trials 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. VMIA CTRA for an investigator initiated study (MS Word) 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.
Checklist for amendments or addenda (MS Word) 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 Medicines Australia - Guidelines for Compensation (87 KB, PDF) Form of indemnity for clinical trials Form of Indemnity for Clinical Trials (76 KB, MS Word) 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. Checklist for indemnities (MS Word) Clinical Trial Notification (CTN) Scheme Form
[ ^ ] This page was last modified on 21/07/10 |